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## Complete Summary

#### GUIDELINE TITLE

2006 UK national guideline for the management of genital tract infection
with *Chlamydia trachomatis*.

#### BIBLIOGRAPHIC SOURCE(S)

Horner PJ, Boag F. 2006 UK national guideline for the management of
genital tract infection with Chlamydia trachomatis. London (UK): British
Association of Sexual Health and HIV (BASHH); 2006. 24 p. \[76
references\]

#### GUIDELINE STATUS

This is the current release of the guideline.

This guideline updates a previous version: Association for Genitourinary
Medicine (AGUM), Medical Society for the Study of Venereal Disease
(MSSVD). 2002 national guideline for the management of *Chlamydia
trachomatis* genital tract infection. London: Association for
Genitourinary Medicine (AGUM), Medical Society for the Study of Venereal
Disease (MSSVD); 2002. Various p.

### \*\* REGULATORY ALERT \*\*

#### FDA WARNING/REGULATORY ALERT

**Note from the National Guideline Clearinghouse (NGC)**: This guideline
references a drug(s) for which important revised regulatory and/or
warning information has been released.

-   [July 08, 2008, Fluoroquinolones (ciprofloxacin, norfloxacin,
    ofloxacin, levofloxacin, moxifloxacin,
    gemifloxacin)](http://www.fda.gov/medwatch/safety/2008/safety08.htm#Fluoroquinolone):
    A BOXED WARNING and Medication Guide are to be added to the
    prescribing information to strengthen existing warnings about the
    increased risk of developing tendinitis and tendon rupture in
    patients taking fluoroquinolones for systemic use.

### COMPLETE SUMMARY CONTENT

 \*\* REGULATORY ALERT \*\*\
 SCOPE\
 METHODOLOGY - including Rating Scheme and Cost Analysis\
 RECOMMENDATIONS\
 EVIDENCE SUPPORTING THE RECOMMENDATIONS\
 BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS\
 CONTRAINDICATIONS\
 QUALIFYING STATEMENTS\
 IMPLEMENTATION OF THE GUIDELINE\
 INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT
CATEGORIES\
 IDENTIFYING INFORMATION AND AVAILABILITY\
 DISCLAIMER

### SCOPE

#### DISEASE/CONDITION(S)

*Chlamydia trachomatis* genital tract infection

#### GUIDELINE CATEGORY

Diagnosis\
Evaluation\
Management\
Prevention\
Treatment

#### CLINICAL SPECIALTY

Infectious Diseases\
Obstetrics and Gynecology\
Urology

#### INTENDED USERS

Physicians

#### GUIDELINE OBJECTIVE(S)

-   To reduce the number of sexually transmitted infections and
    complications of *Chlamydia trachomatis* genital tract infection

-   To offer recommendations on the diagnostic tests, treatment
    regimens, and health promotion principles needed for the effective
    management of *Chlamydia trachomatis*

#### TARGET POPULATION

Men and women in the United Kingdom aged 16 year or older either
presenting with signs and symptoms of a sexually transmitted infection
or undergoing investigation for possible *Chlamydia trachomatis* genital
tract infection

#### INTERVENTIONS AND PRACTICES CONSIDERED

**Diagnosis**

1.  Nucleic acid amplification techniques (NAAT)

2.  Cell culture (routine use not recommended)

3.  Direct fluorescent antibody (DFA) (not recommended routinely)

4.  Enzyme immunoassays (EIA) (not recommended routinely)

**Treatment/Management**

1.  Antibiotics including doxycycline, azithromycin, erythromycin,
    ofloxacin, Deteclo, oxytetracycline, amoxicillin

2.  Patient education

3.  Partner notification

4.  Follow-up, including test of cure in pregnant women or if
    noncompliance or re-exposure is suspected

#### MAJOR OUTCOMES CONSIDERED

-   Sensitivity and specificity of diagnostic tests

-   Microbiological cure rate

-   Partner notification rate

### METHODOLOGY

#### METHODS USED TO COLLECT/SELECT EVIDENCE

Searches of Electronic Databases

#### DESCRIPTION OF METHODS USED TO COLLECT/SELECT THE EVIDENCE

An extensive literature review was carried out using Medline searches
for the years 1970 to 2001 using keywords \"Chlamydia trachomatis\" in
association with \"polymerase chain reaction\" or \"PCR\" or \"ligase
chain reaction\" or \"lcr\" or \"lcx\" and \"immunoenzyme techniques\"
or \"enzyme linked immunosorbent assay.\" \"Chlamydia trachomatis\"
combined with the following keywords: \"detection,\" \"diagnosis,\"
\"treatment.\" The Cochrane Library: \"Chlamydia trachomatis.\" This
literature search was updated in 2005 and included \"nucleic acid
amplification technique,\" \"Aptima,\" \"Probetec\" and \"SDA\".

#### NUMBER OF SOURCE DOCUMENTS

Not stated

#### METHODS USED TO ASSESS THE QUALITY AND STRENGTH OF THE EVIDENCE

Weighting According to a Rating Scheme (Scheme Given)

#### RATING SCHEME FOR THE STRENGTH OF THE EVIDENCE

**Levels of Evidence**

**Ia**

-   Evidence obtained from meta-analysis of randomised controlled trials

**Ib**

-   Evidence obtained from at least one randomised controlled trial

**IIa**

-   Evidence obtained from at least one well designed controlled study
    without randomisation

**IIb**

-   Evidence obtained from at least one type of well designed
    quasi-experimental study

**III**

-   Evidence obtained from well designed, non-experimental descriptive
    studies, such as comparative studies, correlation studies, and case
    control studies

**IV**

-   Evidence obtained from expert committee reports or opinions and/or
    clinical experience of respected authorities

#### METHODS USED TO ANALYZE THE EVIDENCE

Review of Published Meta-Analyses\
Systematic Review

#### DESCRIPTION OF THE METHODS USED TO ANALYZE THE EVIDENCE

Not stated

#### METHODS USED TO FORMULATE THE RECOMMENDATIONS

Expert Consensus

#### DESCRIPTION OF METHODS USED TO FORMULATE THE RECOMMENDATIONS

This guideline has been produced by medical specialists from relevant
disciplines with input from patients attending United Kingdom
genitourinary medicine (GUM) clinics.

#### RATING SCHEME FOR THE STRENGTH OF THE RECOMMENDATIONS

**Grading of Recommendations**

**A (Evidence Levels Ia, Ib)**

-   Requires at least one randomised controlled trial as part of the
    body of literature of overall good quality and consistency
    addressing the specific recommendation

**B (Evidence Levels IIa, IIb, III)**

-   Requires availability of well conducted clinical studies but no
    randomised clinical trials on the topic of recommendation

**C (Evidence Level IV)**

-   Requires evidence from expert committee reports or opinions and/or
    clinical experience of respected authorities

-   Indicates absence of directly applicable studies of good quality

#### COST ANALYSIS

Published cost analyses were reviewed.

It is estimated that complications cost at least 100 million pounds
sterling annually in the United Kingdom. The majority of health economic
valuations demonstrate that chlamydia screening is cost effective.

#### METHOD OF GUIDELINE VALIDATION

External Peer Review\
Internal Peer Review

#### DESCRIPTION OF METHOD OF GUIDELINE VALIDATION

The initial versions of the guidelines were sent to the following for
review:

-   Clinical Effectiveness Group (CEG) members

-   Chairs of UK Regional GU Medicine Audit Committees who had responded
    to an invitation to comment on the guidelines

-   Chair of the Genitourinary Nurses Association (GUNA)

-   President of the Society of Health Advisers in Sexually Transmitted
    Diseases (SHASTD)

-   Clinical Effectiveness Committee of the Faculty of Family Planning
    and Reproductive Health Care (FFP)

Successive drafts have been reviewed by Genitourinary Medicine (GUM)
patients, GUM physicians, nurses, health advisers, and key professional
organisations.

### RECOMMENDATIONS

#### MAJOR RECOMMENDATIONS

Levels of evidence (I-IV) and grades of recommendation (A-C) are defined
at the end of the \"Major Recommendations\" field.

**[Diagnosis]{.underline}**

-   Although the technology for diagnosing *Chlamydia trachomatis*
    continues to be a rapidly developing field, the standard of care for
    all cases, including medico legal cases, is a nucleic acid
    amplification technique (NAAT).

-   NAATs are more sensitive and specific than enzyme immunoassays
    (EIAs) and the Department of Health has recently advised that the
    use of sub-optimal EIAs is no longer appropriate and has provided
    funding to support laboratories moving from EIAs to NAATs
    (Department of Health, 2003). However no test is 100% sensitive or
    specific (Skidmore, Horner, & Mallinson, 2006).

-   Reactive tests should be confirmed in the laboratory either using
    the same NAAT platform but if possible a second platform is to be
    preferred (Skidmore, Horner, & Mallinson, 2006; Health Protection
    Agency, 2004). This improves specificity by countering processing
    errors but at the expense, which is usually judged acceptable, of a
    small reduction in sensitivity caused by specimens with a low
    organism load being missed at re-test (Skidmore, Horner, &
    Mallinson, 2006). Thus therapy should be offered to all patients
    with unconfirmed reactive NAAT results but the significance of this
    result must be discussed with them (Johnson et al., 2002). The
    laboratory report should request an additional specimen for further
    testing when reporting an unconfirmed reactive test, but this may be
    not be possible (Skidmore, Horner, & Mallinson, 2006; Health
    Protection Agency, 2004).

-   An inhibitory control should be used for each specimen (Skidmore,
    Horner, & Mallinson, 2006; Health Protection Agency, 2004) as
    substances may be present in biological fluids which can inhibit
    NAATs. Failure to use an inhibitory control with each specimen will
    lead to false negative results (Horner et al., 2005; Mahony et al.,
    1998; Chong et al., 2003). The Gen-Probe APTIMA system includes a
    nucleic acid extraction stage which removes the majority of
    inhibitors and thus the manufacturers state that no inhibitory
    control is needed (Chong et al., 2003).

-   In general NAATs are 90 to 95% sensitive with the majority of
    studies indicating that as either the number of sites sampled
    increases, or the number of different NAAT used increases, the
    greater the detection of *C. trachomatis* in any given population.

**Sites to Be Sampled**

*Women*

-   A cervical swab (Grade of Recommendation B) or vulvo-vaginal swab
    (Grade of Recommendation C) are specimens of choice. To collect
    cervical specimens, a speculum examination is performed and as the
    sample must contain cervical columnar cells (Loeffelholz et al.,
    2001; Welsh, Quinn, & Gaydos, 1997), swabs should be inserted inside
    the cervical os and firmly rotated against the endocervix.
    Inadequate specimens reduce the sensitivity of NAATs.

-   The vulvo-vaginal swab has a sensitivity of 90 to 95% (Carder et
    al., 1999; Macmillan et al., 2000; Wiesenfeld et al., 1996; Gaydos
    et al., 2003) and can be either taken by the patient or health care
    worker (Schachter et al., 2003). Studies indicate that sensitivities
    similar to a cervical swab are obtainable. Currently, only the
    APTIMA system (Gen-Probe Inc., San Diego, CA) has U.S. Food and Drug
    Administration (FDA) approval for this specimen type.

-   If a speculum examination is not possible then urine (Grade of
    Recommendation B) samples can be utilized.

-   Variable sensitivities (65 to 100%) have been reported using the
    first catch urine (FCU) specimen (McCartney, Walker, & Scoular,
    2001; Schachter et al., 2003; Van Der Pol et al., 2001; Jensen,
    Thorsen, & Moller, 1997; Moncada et al., 2004). When processed by
    inexperienced staff it may perform with sensitivity \<90% (Schachter
    et al., 2003). Patients should hold their urine for at least 1 hour
    (Johnson et al., 2002) (maybe 2 hours with some kits, check
    manufacturer\'s instructions) before providing a FCU specimen.

*Men*

-   First voided urine sample is reported to be as good as a urethral
    swab. (Van Der Pol et al., 2001; Chernesky et al., 2005; Crotchfelt
    et al, 1997; Young et al, 1998; Sugunendran et al., 2001) Urine
    samples are easy to collect, do not cause discomfort and thus are
    preferable to urethral swabs. Urethral swabs should be inserted 2 to
    4 cm inside the urethra and rotated once before removal (Grade of
    Recommendation C).

-   Patients should hold their urine at least 1 hour before being tested
    (Johnson et al., 2002), (maybe 2 hours with some kits, check
    manufacturer\'s instructions).

*Rectal, Pharyngeal and Conjunctival Specimens, Men and Women*

-   Currently none of the NAATs have FDA approval for these sites. Only
    culture or direct fluorescent antibody (DFA) are recommended (Grade
    of Recommendation A). However, in the absence of culture or DFA
    tests, NAATs may be used (Grade of Recommendation C).

> Rectal swabs should be obtained via proctoscopy in symptomatic
> patients, but can be taken blind from the rectal mucosa in
> asymptomatics.

-   Due to the emergence of rectal Lymphogranuloma venereum (LGV)
    infection in men who have sex with men (French, Ison, & Macdonald,
    2005), the current (2006) recommended method of detecting rectal LGV
    infection is to perform a rectal NAAT which, if positive, is sent to
    the Health Protection Authority for confirmation.

**Medico Legal Cases**

For medico legal cases a NAAT should be taken from all the sites where
penetration has occurred. This guideline recommends NAAT rather than
culture due to the low sensitivity (60 to 80%) of culture and its lack
of availability in many centres (Grade of Recommendation D).

-   A reactive NAAT result must be confirmed using a different NAAT
    (Johnson et al., 2002). Ideally, two swabs should be taken from each
    site, one for testing and one for confirmation if the initial test
    is positive. This avoids potential compatibility problems when
    retesting specimens using a different platform (Skidmore, Horner, &
    Mallinson, 2006). There is evidence that the Becton Dickinson
    ProbeTec ET strand displacement amplification (SDA) assay has a
    lower analytical sensitivity than Roche Cobas Amplicor PCR (Chalker
    et al., 2005) for some serotypes, which means that SDA may not be
    suitable for the confirmation of PCR results. There are also data to
    suggest that Gen-Probe APTIMA system has a higher sensitivity than
    the other two assays discussed (Schacter et al., 2005). Although,
    this system does have its own confirmatory assay with matching
    sensitivity it uses the same methodology, on the same specimen, thus
    theoretically some causes of false positives may not be eliminated
    (Johnson et al., 2002).

**Cell Culture**

-   Sensitivity 60 to 80%

-   100% specificity

-   Expertise essential

-   Expensive---and only limited availability nationally

-   Can be used on all specimen types

-   Routine use is not recommended due to high cost and low sensitivity.

**Enzyme Immunoassays (EIAs)**

-   The sensitivity of the majority of EIAs is probably only 40 to 70%
    and their use is not recommended. This guideline recommends
    laboratories to move to the use of NAATs utilizing Department of
    Health dedicated funding (Westrom, 1994).

-   Should be not used on non-invasive specimens in women, nor on rectal
    or throat specimens in women or men.

**Direct Fluorescent Antibody (DFA)**

-   Routine use is not recommended.

-   Labour intensive, and although a \>80% sensitivity is achievable,
    this requires skilled personnel using a cut off of 2 elementary
    bodies.

-   Unsuitable for large numbers of specimens (\>30/day).

-   Will accommodate all specimen types including rectal and pharyngeal

**[Management]{.underline}**

**General Advice**

Ideally, treatment should be effective (microbiological cure rate
\>95%), easy to take (not more than twice daily), with a low side effect
profile, and cause minimal interference with daily lifestyle (Grade of
Recommendation C). Uncomplicated genital tract infection with *C.
trachomatis* is not an indication for removal of an intrauterine system
(IUS) or intrauterine device (IUD).

Patients should be advised to avoid sexual intercourse (including oral
sex) until they and their partner(s) have completed treatment (or wait 7
days if treated with azithromycin). Advice regarding appropriate action
if using hormonal contraceptives is also required.

Patients should be given detailed explanation of their condition with
particular emphasis on the long--term implications for them and their
partner(s). This should be reinforced by giving them clear, accurate
written information.

**Further Investigation**

All patients diagnosed with *C .trachomatis* should be encouraged to
have screening for other sexually transmitted infections (STIs),
including a human immunodeficiency virus (HIV) test and, where
indicated, hepatitis B screening and vaccination (Grade of
Recommendation C). If the patient is within the window period for HIV
and syphilis, these should be repeated at an appropriate time interval.
All contacts of *C. trachomatis* should be offered the same screening
tests.

**Treatment of Genital, Rectal and Pharyngeal Uncomplicated Infection
(see appropriate guidelines for treatment of complications) and
Epidemiological Treatment**

*Recommended Regimens* (Grade of Recommendation A)

-   Doxycycline 100 mg twice a day (bd) for 7 days (contraindicated in
    pregnancy)

> *or*

-   Azithromycin 1 g orally in a single dose

*Alternative Regimens* (Grade of Recommendation A)

-   Erythromycin 500 mg bd for 10 to 14 days

> *or*

-   Ofloxacin 200 mg bd or 400 mg once a day for 7 days

**Studies of Anti-Microbial Efficacy**

*Doxycycline and Azithromycin*

For information on the studies of the efficacy of azithromycin and
doxycycline, see the original guideline document.

*Other Anti-Microbials*

The information from published studies on efficacy of other
anti-microbials is considerably less than that available for
azithromycin and doxycycline. It should not be assumed that these are
more efficacious than either doxycycline or azithromycin.

[Ofloxacin (Grade of Recommendation B)]{.underline}

-   It is unknown whether 200 mg twice a day is superior to 400 mg once
    a day (Kitchen et al., 1990).

-   Ofloxacin has similar efficacy to doxycycline and a better
    side-effect profile but is considerably more expensive, so is not
    recommended as first-line treatment.

-   Resistance to ofloxacin has been demonstrated in vivo and in vitro,
    but appears to be rare (64).

-   No long term follow up (\>6 weeks) data.

[Erythromycin (Grade of Recommendation A)]{.underline}

-   Erythromycin is less efficacious than either azithromycin or
    doxycycline.

-   When taken four times a day, 20 to 25% may experience side effects
    sufficient to cause the patient to discontinue treatment (Linneman,
    Heaton, & Ritchey, 1987).

-   There are only limited data on erythromycin 500 mg twice a day, with
    efficacy reported to be between 73 and 95%. A 10 to 14 day course
    appears to be more efficacious than a 1-week course of 500 mg twice
    a day, with a cure rate \>95% (Tobin, Harindra, & Mani, 2004; Ross,
    Crean, & McMillan, 1996).

-   Resistance to erythromycin has been demonstrated in vivo and appears
    to be rare. It has not been documented to be significant in vivo.

[Other Tetracyclines (Grade of Recommendation A)]{.underline}

-   \"Deteclo\" (registered trademark) is probably as efficacious as
    doxycycline (Munday et al., 1995). However, photosensitivity occurs
    more frequently and there are insufficient data on efficacy if
    compliance is poor.

-   Oxytetracycline 500 mg bd 10 days has also been shown to be
    effective (Tobin, Harindra, & Mani, 2004)

**Pregnancy and Breast Feeding**

*Recommended Regimens* (Grade of Recommendation A)

-   Erythromycin 500 mg four times a day for 7 days

> *or*

-   Erythromycin 500 mg twice a day for 14 days

> *or*

-   Amoxicillin 500 mg three times a day for 7 days

> *or*

-   Azithromycin 1 g stat (see caution below from the British National
    Formulary \[BNF\])

Due to higher positive chlamydia tests after treatment in pregnancy,
attributed to either less efficacious treatment regime, non compliance,
or re-infection, it is recommended that pregnant woman must have a test
of cure 5 weeks after completing therapy, 6 weeks later if given
azithromycin.

-   Doxycycline and ofloxacin are contraindicated in pregnancy

-   Azithromycin is probably less than 95% effective (Jacobson et al.,
    2001; Kacmar et al., 2001; Brocklehurst & Rooney, 2000). The safety
    of azithromycin in pregnancy and lactating mothers has not yet been
    fully assessed, although available data indicate that it is safe
    (Brocklehurst & Rooney, 2000). World Health Organization (WHO)
    Guidelines recommend 1 g stat to treat *C. trachomatis* in
    pregnancy; the BNF recommends its use in pregnancy and lactation
    only if no alternative is available.

-   Erythromycin has a significant side effect profile and is less than
    95% effective. There are no trials of erythromycin 500 mg twice a
    day for 14 days, which would be better tolerated than four times a
    day although the follow-up data from the Portsmouth pilot study
    suggests it is efficacious (Tobin, Harindra, & Mani, 2004).

-   Amoxycillin had a similar cure rate to erythromycin in a
    meta-analysis and had a much better side effect profile
    (Brocklehurst & Rooney, 2000). However, penicillin in vitro has been
    shown to induce latency and re-emergence of infection at a later
    date is a theoretical concern of some experts.

**Compliance with Therapy**

In general, compliance with therapy is improved if there is a positive
therapeutic relationship between the patient and the doctor
(Sanson-Fisher, Bowman, & Armstrong, 1992) and/or nurse.

This can probably be improved if the following are applied (Grade of
Recommendation C):

Discuss with patient and provide clear written information on:

-   What *C. trachomatis* is and how it is transmitted

    -   It is primarily sexually transmitted.

    -   If asymptomatic there is evidence that it could have persisted
        for months or years.

-   The diagnosis of *C. trachomatis*, particularly

    -   It is often asymptomatic in both men and women.

    -   Whilst tests are accurate, no test is absolutely so.

-   The complications of untreated *C. trachomatis*

-   Side effects and importance of complying fully with treatment and
    what to do if a dose is missed

-   Advice regarding antibiotics and hormonal contraception

-   The importance of their sexual partner(s) being evaluated and
    treated

-   Advice to abstain from sexual intercourse until they and their
    partner(s) have completed therapy (and waited 7 days if treated with
    azithromycin)

-   Advice on safer sexual practices, including advice on correct,
    consistent condom use

**Reducing the Risk of Individuals Retesting Chlamydia-Positive
Following Treatment**

*Recommendations*

-   Advise (and document that advice given) no genital, oral, or anal
    sex, even with a condom, until both index patient and their
    partner(s) have completed treatment or if the partner(s) choose
    testing only until the partner(s) have a negative test.

-   Abstain as above from sexual activity, for one week after
    azithromycin 1 g stat.

*Management of Sexual Partners*

-   All patients identified with *C. trachomatis* should have partner
    notification discussed at treatment by a health care professional.

-   The method of partner notification agreed for each partner/contact
    identified should be documented, as should partner notification
    outcomes.

-   All sexual partners should be offered, and encouraged to take up a
    full STI screen, including HIV test and if indicated hepatitis B
    screening +/- vaccination.

-   Epidemiological treatment for *C. trachomatis* should be offered. If
    declined, patients must be advised to abstain from sex until they
    have received a negative result. If found to be positive, any other
    potentially exposed partner(s) needs screening and the offer of
    epidemiological treatment.

[Look Back Period]{.underline}

Only limited evaluation has taken place of the incubation period
following exposure to the development of symptoms. In the United Kingdom
a cut-off of 4 weeks is used to identify those sexual partner(s)
potentially at risk if the index patient is symptomatic. If the index
case is asymptomatic, an arbitrary cut off of 6 months, or until the
last previous sexual partner (whichever is the longer time period), is
used. Common sense needs to be used in assessing which sexual partner(s)
may have been at risk in these situations.

Those at risk should be informed and invited to attend for evaluation
and epidemiological treatment even if tests are negative. This may be
patient led or provider led.

[Follow Up]{.underline}

Follow up by phone may be both more efficacious and cost effective than
by re-attendance.

This is an important part of the management of chlamydial infection and
it has a number of objectives including:

-   Following up partner notification

-   Reinforcing health education

-   Ensuring compliance with treatment and abstinence from sexual
    intercourse until partner(s) have completed antibiotics (if treated
    with azithromycin waiting seven days)

-   There is evidence to suggest that follow-up by phone may be more
    efficacious than asking the patient to re-attend. It is therefore
    likely that the former method is more cost effective (Apoola,
    Boothby, & Radcliffe, 2004).

-   Re-treat non-compliant and/or re-exposed individuals

*Test of Cure*

A test of cure is not routinely recommended but should be performed in
pregnancy or if non-compliance or re-exposure is suspected. It should be
deferred for 5 weeks (6 weeks if azithromycin given) after treatment is
completed.

**[Definitions]{.underline}**:

**Grading of Recommendations**

**A (Evidence Levels Ia, Ib)**

-   Requires at least one randomised controlled trial as part of the
    body of literature of overall good quality and consistency
    addressing the specific recommendation

**B (Evidence Levels IIa, IIb, III)**

-   Requires availability of well conducted clinical studies but no
    randomised clinical trials on the topic of recommendation

**C (Evidence Level IV)**

-   Requires evidence from expert committee reports or opinions and/or
    clinical experience of respected authorities

-   Indicates absence of directly applicable studies of good quality

**Levels of Evidence**

**Ia**

-   Evidence obtained from meta-analysis of randomised controlled trials

**Ib**

-   Evidence obtained from at least one randomised controlled trial

**IIa**

-   Evidence obtained from at least one well designed controlled study
    without randomisation

**IIb**

-   Evidence obtained from at least one type of well designed
    quasi-experimental study

**III**

-   Evidence obtained from well designed, non-experimental descriptive
    studies, such as comparative studies, correlation studies, and case
    control studies

**IV**

-   Evidence obtained from expert committee reports or opinions and/or
    clinical experience of respected authorities

#### CLINICAL ALGORITHM(S)

None provided

### EVIDENCE SUPPORTING THE RECOMMENDATIONS

#### REFERENCES SUPPORTING THE RECOMMENDATIONS

[References open in a new
window](http://www.guideline.gov/summary/select_ref.aspx?doc_id=10176)

#### TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The type of supporting evidence is graded and identified for selected
recommendations (see \"Major Recommendations\").

### BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS

#### POTENTIAL BENEFITS

Appropriate diagnosis, treatment, and management of patients with
*Chlamydia trachomatis* genital tract infection and prevention of *C.
trachomatis* infection in sexual partners

#### POTENTIAL HARMS

-   Erythromycin is less efficacious than either azithromycin or
    doxycycline. When taken four times a day, 20 to 25% may experience
    side-effects sufficient to cause the patient to discontinue
    treatment.

-   Amoxycillin had a similar cure rate to erythromycin in a
    meta-analysis and had a much better side effect profile. However,
    penicillin in vitro has been shown to induce latency, and
    re-emergence of infection at a later date is a theoretical concern
    of some experts.

### CONTRAINDICATIONS

#### CONTRAINDICATIONS

Doxycycline and ofloxacin are contraindicated in pregnancy.

### QUALIFYING STATEMENTS

#### QUALIFYING STATEMENTS

The recommendations in this guideline may not be appropriate for use in
all clinical situations. Decisions to follow these recommendations must
be based on the professional judgement of the clinician and
consideration of individual patient circumstances and available
resources. All possible care has been undertaken to ensure the
publication of the correct dosage of medication and route of
administration. However, it remains the responsibility of the
prescribing physician to ensure the accuracy and appropriateness of the
medication they prescribe.

### IMPLEMENTATION OF THE GUIDELINE

#### DESCRIPTION OF IMPLEMENTATION STRATEGY

The following auditable outcome measures are provided:

-   Compliance with clinical standards of care

-   Partner notification

#### IMPLEMENTATION TOOLS

Audit Criteria/Indicators

For information about
[availability](#identifying-information-and-availability), see the
\"Availability of Companion Documents\" and \"Patient Resources\" fields
below.

### INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT CATEGORIES

#### IOM CARE NEED

Getting Better\
Staying Healthy

#### IOM DOMAIN

Effectiveness\
Patient-centeredness

### IDENTIFYING INFORMATION AND AVAILABILITY

#### BIBLIOGRAPHIC SOURCE(S)

Horner PJ, Boag F. 2006 UK national guideline for the management of
genital tract infection with Chlamydia trachomatis. London (UK): British
Association of Sexual Health and HIV (BASHH); 2006. 24 p. \[76
references\]

#### ADAPTATION

Not applicable: The guideline was not adapted from another source.

#### DATE RELEASED

1999 Aug (revised 2006)

#### GUIDELINE DEVELOPER(S)

British Association for Sexual Health and HIV - Medical Specialty
Society

#### SOURCE(S) OF FUNDING

No specific or external funding was sought or provided in the
development of this guideline.

#### GUIDELINE COMMITTEE

Clinical Effectiveness Group (CEG) and British Association for Sexual
Health and HIV (BASHH)

#### COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

*Authors*: Patrick J Horner, Department of Genitourinary Medicine, The
Milne Centre, Bristol Royal Infirmary, Bristol; and Fiona Boag,
Consultant Physician, Department of GUM, Chelsea & Westminster Hospital,
London

*Clinical Effectiveness Group (CEG) Members*: Keith Radcliffe (Chair);
Imtyaz Ahmed-Jushuf; David Daniels; Mark FitzGerald; Neil Lazaro;
Gillian McCarthy; Guy Rooney

#### FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

P. Horner - none.\
F. Boag - none.

#### GUIDELINE STATUS

This is the current release of the guideline.

This guideline updates a previous version: Association for Genitourinary
Medicine (AGUM), Medical Society for the Study of Venereal Disease
(MSSVD). 2002 national guideline for the management of *Chlamydia
trachomatis* genital tract infection. London: Association for
Genitourinary Medicine (AGUM), Medical Society for the Study of Venereal
Disease (MSSVD); 2002. Various p.

#### GUIDELINE AVAILABILITY

Electronic copies: Available from the [British Association for Sexual
Health and HIV Web site](http://www.bashh.org/guidelines).

#### AVAILABILITY OF COMPANION DOCUMENTS

The following are available:

-   Specifications for the development of UK guidelines on the
    management of sexually transmitted infections (STIs) and closely
    related conditions 2005. London (UK): British Association of Sexual
    Health and HIV (BASHH); 2005. 14 p. Electronic copies: Available in
    Portable Document Format (PDF) from the [British Association for
    Sexual Health and HIV Web
    site](http://www.bashh.org/documents/25/25.pdf).

Additionally, auditable outcome measures can be found in the [original
guideline document](http://www.bashh.org/documents/61/61.pdf).

#### PATIENT RESOURCES

None available

#### NGC STATUS

This summary was completed by ECRI on June 15, 2000. The information was
verified by the guideline developer on October 13, 2000. This summary
was updated by ECRI on June 24, 2002. The updated information was
verified by the guideline developer on February 6, 2007. This summary
was updated by ECRI Institute on July 28, 2008 following the U.S. Food
and Drug Administration advisory on fluoroquinolone antimicrobial drugs.

#### COPYRIGHT STATEMENT

This NGC summary is based on the original guideline, which is subject to
the guideline developer\'s copyright restrictions.

### DISCLAIMER

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Date Modified: 11/10/2008