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## Complete Summary

#### GUIDELINE TITLE

Chlamydial urethritis and cervicitis.

#### BIBLIOGRAPHIC SOURCE(S)

Finnish Medical Society Duodecim. Chlamydial urethritis and cervicitis.
In: EBM Guidelines. Evidence-Based Medicine \[Internet\]. Helsinki,
Finland: Wiley Interscience. John Wiley & Sons; 2006 Jun 13 \[Various\].

#### GUIDELINE STATUS

This is the current release of the guideline.

This guideline updates a previous version: Finnish Medical Society
Duodecim. Chlamydial urethritis and cervicitis. In: EBM Guidelines.
Evidence-Based Medicine \[CD-ROM\]. Helsinki, Finland: Duodecim Medical
Publications Ltd.; 2005 Mar 30 \[Various\].

### \*\* 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\
 IMPLEMENTATION OF THE GUIDELINE\
 INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT
CATEGORIES\
 IDENTIFYING INFORMATION AND AVAILABILITY\
 DISCLAIMER

### SCOPE

#### DISEASE/CONDITION(S)

Chlamydial urethritis and cervicitis

#### GUIDELINE CATEGORY

Diagnosis\
Evaluation\
Management\
Prevention\
Screening\
Treatment

#### CLINICAL SPECIALTY

Family Practice\
Internal Medicine\
Obstetrics and Gynecology\
Urology

#### INTENDED USERS

Health Care Providers\
Physicians

#### GUIDELINE OBJECTIVE(S)

Evidence-Based Medicine Guidelines collect, summarize, and update the
core clinical knowledge essential in general practice. The guidelines
also describe the scientific evidence underlying the given
recommendations.

#### TARGET POPULATION

-   Young adult and adult men and women with (or with symptoms
    suggestive of) chlamydial urethritis or cervicitis (*Diagnosis,
    Treatment, Management, Secondary Prevention*)

-   Family planning clinic customers and, in general, young women who
    see their physician to renew their contraceptive pill prescription
    (*Screening*)

-   Partners of patients diagnosed with chlamydial infections
    (*Screening*)

#### INTERVENTIONS AND PRACTICES CONSIDERED

**Evaluation/Diagnosis**

1.  Assessment of clinical symptoms and signs

2.  Laboratory diagnostics

    -   Gene amplification methods, such as polymerase chain reaction
        (PCR) and ligase chain reaction (LCR)

    -   First-void urine samples or alternatives (e.g., analyses of
        samples from the urethra, cervix, or cornea of the eye by gene
        amplification methods)

    -   Chlamydial serology for chronic infections

    -   Immunoglobulin G (IgG) antibody titres

**Treatment/Management**

1.  Pharmacologic treatment

    -   Azithromycin as the treatment of choice for chlamydial infection

    -   Other alternatives: tetracycline or doxycycline

    -   Combination of antibiotics in pelvic infections

2.  Testing of the permanent sexual partner of the index patient before
    treating partner

3.  Post-treatment follow-up and tracing the contacts of the patient

**Screening/Prevention**

1.  Targeted and/or systematic screening for asymptomatic infections

2.  Tracing contacts and partner screening

#### MAJOR OUTCOMES CONSIDERED

-   Sensitivity and specificity of diagnostic methods for chlamydial
    infection

-   Microbiological cure rate after treatment

-   Treatment efficacy (defined as the number of subjects who completed
    their course of antibiotics with negative test of cure)

-   Complications of chlamydial infection, such as pelvic inflammatory
    disease and ectopic pregnancy

-   Rate of contact referral and rate of partners presenting for medical
    evaluation

-   Rate of mother-to-child transmission of chlamydial infection

-   Adverse effects of treatment

-   Cost effectiveness of screening interventions

### METHODOLOGY

#### METHODS USED TO COLLECT/SELECT EVIDENCE

Hand-searches of Published Literature (Primary Sources)\
Hand-searches of Published Literature (Secondary Sources)\
Searches of Electronic Databases

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

The evidence reviewed was collected from the Cochrane database of
systematic reviews and the Database of Abstracts of Reviews of
Effectiveness (DARE). In addition, the Cochrane Library and medical
journals were searched specifically for original publications.

#### 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**

A.  Strong research-based evidence. Multiple relevant, high-quality
    scientific studies with homogenic results.

B.  Moderate research-based evidence. At least one relevant,
    high-quality study or multiple adequate studies.

C.  Limited research-based evidence. At least one adequate scientific
    study.

D.  No research-based evidence. Expert panel evaluation of other
    information.

#### 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

Not stated

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

Not applicable

#### COST ANALYSIS

Guideline developers reviewed a cost-benefit analysis of first-void
urine in a Chlamydia trachomatis screening programme. Screening for
chlamydial infection was found to be cost-effective if the prevalence of
chlamydial infection exceeded 3% in the population screened.

#### METHOD OF GUIDELINE VALIDATION

Peer Review

#### DESCRIPTION OF METHOD OF GUIDELINE VALIDATION

Not stated

### RECOMMENDATIONS

#### MAJOR RECOMMENDATIONS

The levels of evidence \[A-D\] supporting the recommendations are
defined at the end of the \"Major Recommendations\" field.

**Aims**

-   To diagnose the disease and treat the patient in time to avoid the
    serious complications of prolonged or recurrent infection (pelvic
    inflammatory disease, infertility, ectopic pregnancy)

-   To examine and treat the person who is the source of the infection
    and any other persons who might have been subsequently infected, in
    order to prevent the spread of the chlamydial infection

**Epidemiology**

-   Young adults with many sexual contacts are especially at risk, and
    the use of oral contraceptives increases the likelihood of
    contracting the disease (Hiltunen-Back et al., 2001).

-   Asymptomatic infections promote the spread of the disease. The time
    from infection to diagnosis is on average four weeks but may be up
    to many months (Hiltunen-Back et al., 2001).

-   By the time of diagnosis, a quarter of patients have already had a
    new sexual relationship, which presents a challenge for tracing the
    infection (Hiltunen-Back et al., 2001).

-   On the basis of extensive material, men are most commonly (60%)
    infected by a temporary sexual partner and women by a permanent
    partner (Hiltunen-Back et al., 2001). Prostitutes and foreigners do
    not constitute a significant source of infection in most countries.

**Early Symptoms**

-   The \"incubation period\" from chlamydial infection to the emergence
    of symptoms is one to three weeks (i.e. longer than in gonorrhoea).
    About a quarter of men and most women experience no particular early
    symptoms from chlamydial infection, and many of them become
    asymptomatic carriers of chlamydial disease.

-   In men, urethritis is marked by scant, watery (later mucous)
    discharge from the urethra. Other symptoms include an aching pain
    and dysuria. In women, there is dysuria, pollakisuria, and mild
    leucorrhoea. Cervicitis is a relatively common finding. It is
    manifested as mucopurulent discharge and oedema or bleeding tendency
    of the orifice of the uterus.

**Late Symptoms and Complications**

-   In women, prolonged chlamydial infection often results in
    **endometritis** and **salpingitis**. These conditions are not
    always associated with severe symptoms; the patient may have just
    slight fever or mild lower abdominal pain. Endometritis may also
    cause irregular uterine bleeding. **Pelvic inflammatory disease
    (PID)** is an important late complication of chlamydial infection;
    it generally requires inpatient treatment. Perihepatitis is a rare
    complication of chlamydial infection.

-   Late complications of extensive and, especially, recurrent
    chlamydial infection also include tubal damage, which in turn causes
    **infertility** and **ectopic pregnancies** (Scholes et al., 1996;
    Egger et al., 1998).

-   In men, chlamydial infection is an important cause of
    **epididymitis**, whereas the etiological significance of chlamydia
    in prostatitis is considered small.

-   Chlamydial infection can trigger the development of **reactive
    arthritis** (uroarthritis, Reiter\'s disease) in both men and women.

**Diagnostics**

**Clinical Symptoms and Signs**

-   Chlamydial infection can be suspected but never diagnosed on the
    basis of symptoms alone. A burning sensation and mucous discharge
    from the urethra are common symptoms in men after unprotected sexual
    intercourse with a temporary partner. Although Gram or methylene
    blue stains of plain smear specimens are usually rich in white blood
    cells, chlamydia is found to be the cause of the infection in only
    half the patients. A reliable diagnosis of chlamydial infection in
    both men and women can therefore be reached only by appropriate
    microbiological sampling.

**Laboratory Diagnostics**

-   Gene amplification methods have replaced previous techniques, and
    first-void urine samples have acquired an established position in
    chlamydial diagnostics in both men and women.

-   Gene amplification methods, such as polymerase chain reaction (PCR)
    and ligase chain reaction (LCR), are based on multiplication of
    chlamydial nucleic acids with specific probes. The main assets of
    the methods are their high sensitivity and the fact that they,
    unlike culture methods, yield a positive result also when there is
    no living chlamydia in the sample. Compared with traditional culture
    methods, gene amplification methods reveal 5 to 7% more cases of
    chlamydial infection, and false positives are practically
    nonexistent (Pasternack, Vuorinen, & Miettinen, 1997; Puolakkainen
    et al., 1998). The price of these tests has come down to an
    acceptable level. Today chlamydia and gonorrhoea can be analysed on
    the same sample if required.

-   First-void urine samples are used for chlamydial diagnostics in both
    men and women. Samples are taken when at least five to seven days
    have passed since the potential time of acquirement of infection.
    The patient has to refrain from voiding for 2 hours before urine
    sampling. The sample (10 ml) is sent to a laboratory in the normal
    way. If needed, the sample may be kept refrigerated for one or two
    days.

-   As an alternative to first-void urine, women may give urethral and
    cervical swab samples that are then analysed by the same gene
    amplification methods. Even samples from the cornea of the eye can
    be examined by gene amplification techniques.

-   Gene amplification is a rapid method, with results being available
    within as little as 24 hours. In practice, large laboratories
    analyse samples two or three times a week.

-   First-void urine samples are well suited for home screening of risk
    groups or sexual partners (Östergaard et al., 1998).

-   Chlamydial serology may be useful in chronic infections. High
    immunoglobulin G (IgG) antibody titres are often present in pelvic
    infections and also in other complications. An isolated positive
    test indicates that the patient has a history of chlamydial
    infection.

**Treatment of Chlamydial Infection**

-   Chlamydia trachomatis is sensitive to macrolides and tetracyclines.
    Clindamycin is also relatively effective against this species,
    fluoroquinolones less so. The common cephalosporins and penicillin
    have poor efficacy.

-   **Azithromycin 1 g as a single dose** is the treatment of choice for
    chlamydial infection. It is suitable also during pregnancy
    (Brocklehurst & Rooney, 1998) \[**B**\]. Alternatives include
    tetracycline 500 mg x 3 or doxycycline 100 mg x 2 for 7 to 10 days.

-   Some 10% of patients get mild gastric side effects from azithromycin
    and tetracyclines. Azithromycin therapy has the benefit of 100%
    compliance; it is more expensive than the common tetracyclines,
    however. Controlled studies have shown similar therapeutic outcomes
    for these drugs, with 95 to 97% of patients being cured.

-   Chlamydial infections of the throat, anus, or eyes are treated with
    azithromycin for three to five days. For mild complications,
    patients are given tetracycline or doxycycline for two to three
    weeks, for reactive arthritis triggered by chlamydial infection even
    longer. In pelvic infections, combinations of antibiotics are used,
    as other bacteria, such as anaerobes, may be involved.

-   The permanent sexual partner of the index patient should be tested
    before any treatment since the partner is not necessarily infected.
    The suitability of the antibiotic for the partner should also be
    ascertained, as well as ensuring that the female partner to be
    treated is not pregnant. Furthermore, the partner may have
    transmitted the infection to other persons; an issue that can only
    be clarified by having the partner visit the physician or clinic.

**Post-treatment Follow-up and Tracing the Contacts of the Patient**

-   A follow-up visit should only take place after three to four weeks
    because the presence of gene traces may produce a false positive
    result in an earlier re-test.

-   Every physician treating patients with chlamydial infections is
    required to trace the sexual contacts of their patients (Mathews et
    al., 2001) \[**B**\]. The physician should enquire the index patient
    whether the person who is the source of the infection and any
    persons potentially infected have been tested for chlamydia and
    received treatment as needed. If desired, the attending physician
    may delegate the screening of sexual partners to a physician
    responsible for communicable diseases.

**Screening for Asymptomatic Infections**

-   It has been shown that targeted screening for chlamydial infections
    is effective in preventing pelvic inflammatory disease (PID) and
    ectopic pregnancies (Scholes et al., 1996; Egger et al., 1998;
    Pimenta et al., 2000).

-   Screening for chlamydial infection is cost-effective if the
    prevalence of chlamydia infection exceeds 3% in the population
    screened (Paavonen et al., 1998). Systematic screening for
    chlamydial infection has been considered relevant among family
    planning clinic customers and in general those young women who see
    their physician to renew their contraceptive pill prescription,
    especially if there is a history of temporary sexual partners.

-   Tracing the contacts of the patient is the most effective way of
    combating the disease. Partner screening normally yields 20 to 30%
    positive cases. The practice of taking first-void urine samples from
    the partner at home has increased the number of detected infections
    by 50% compared with the usual practice of partner notification
    (Östergaard et al., 1998). Many young people are unaware that
    chlamydial infection is often asymptomatic, which reduces and delays
    testing for chlamydia.

-   Recent seroepidemiological studies have indicated an association
    between a history of chlamydial infection and the development of
    cervical carcinoma (Koskela et al., 2000; Anttila et al., 2001). The
    exact causal relationship remains to be determined, however.
    Therefore, no seroepidemiological screening programmes have been
    undertaken as yet.

**Related Evidence**

-   Patient assistance at facilitating patient referral and provider
    referral may increase partner notification for sexually transmitted
    diseases (Oxman et al., 1994 \[**C**\].

-   Provider referral and contract referral are more effective than
    patient referral among patients in increasing the rate of partners
    presenting for medical evaluation (Mathews et al., 2001) \[**B**\].

-   Amoxicillin and erythromycin are equally effective for antenatal
    chlamydial cervicitis (Turrentine & Newton, 1995) \[**B**\].

**Definitions**:

**Levels of Evidence**

A.  Strong research-based evidence. Multiple relevant, high-quality
    scientific studies with homogenic results.

B.  Moderate research-based evidence. At least one relevant,
    high-quality study or multiple adequate studies.

C.  Limited research-based evidence. At least one adequate scientific
    study.

D.  No research-based evidence. Expert panel evaluation of other
    information.

#### 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=9852)

#### TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

Concise summaries of scientific evidence attached to the individual
guidelines are the unique feature of the Evidence-Based Medicine
Guidelines. The evidence summaries allow the clinician to judge how
well-founded the treatment recommendations are. The type of supporting
evidence is identified and graded for select recommendations (see the
\"Major Recommendations\" field).

### BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS

#### POTENTIAL BENEFITS

Appropriate identification, diagnosis, and treatment of the patient with
chlamydial urethritis and cervicitis may help avoid the serious
complications of prolonged or recurrent infection (e.g., pelvic
inflammatory disease, infertility, ectopic pregnancy) as well as prevent
the spread of infection.

#### POTENTIAL HARMS

Adverse effects of medications: Some 10% of patients get mild gastric
side effects from azithromycin and tetracyclines.

### IMPLEMENTATION OF THE GUIDELINE

#### DESCRIPTION OF IMPLEMENTATION STRATEGY

An implementation strategy was not provided.

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

#### IOM CARE NEED

Getting Better\
Staying Healthy

#### IOM DOMAIN

Effectiveness

### IDENTIFYING INFORMATION AND AVAILABILITY

#### BIBLIOGRAPHIC SOURCE(S)

Finnish Medical Society Duodecim. Chlamydial urethritis and cervicitis.
In: EBM Guidelines. Evidence-Based Medicine \[Internet\]. Helsinki,
Finland: Wiley Interscience. John Wiley & Sons; 2006 Jun 13 \[Various\].

#### ADAPTATION

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

#### DATE RELEASED

2001 Jun 5 (revised 2006 Jun 13)

#### GUIDELINE DEVELOPER(S)

Finnish Medical Society Duodecim - Professional Association

#### SOURCE(S) OF FUNDING

Finnish Medical Society Duodecim

#### GUIDELINE COMMITTEE

Editorial Team of EBM Guidelines

#### COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

*Primary Author*: Timo Reunala

#### FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

Not stated

#### GUIDELINE STATUS

This is the current release of the guideline.

This guideline updates a previous version: Finnish Medical Society
Duodecim. Chlamydial urethritis and cervicitis. In: EBM Guidelines.
Evidence-Based Medicine \[CD-ROM\]. Helsinki, Finland: Duodecim Medical
Publications Ltd.; 2005 Mar 30 \[Various\].

#### GUIDELINE AVAILABILITY

This guideline is included in \"EBM Guidelines. Evidence-Based
Medicine\" available from Duodecim Medical Publications, Ltd, PO Box
713, 00101 Helsinki, Finland; e-mail: <info@ebm-guidelines.com>; Web
site: [www.ebm-guidelines.com](http://www.ebm-guidelines.com/).

#### AVAILABILITY OF COMPANION DOCUMENTS

None available

#### PATIENT RESOURCES

None available

#### NGC STATUS

This summary was completed by ECRI on December 17, 2002. The information
was verified by the guideline developer as of February 7, 2003. This
summary was updated by ECRI on September 8, 2004, June 14, 2005, and
December 22, 2006. 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

#### NGC DISCLAIMER

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© 1998-2008 National Guideline Clearinghouse

Date Modified: 11/3/2008