Clinical trial NCT01178762: The Effect of Oral Azithromycin in the Treatment of Chlamydial Conjunctivitis
Official title: The Effect of Oral Azithromycin in the Treatment of Chlamydial Conjunctivitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chlamydial Conjunctivitis
Keywords: Oral Azithromycin
Chlamydial Conjunctivitis
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2010-08-10
Enrollment: 42
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Chlamydia trachomatis is one of the major causes of sexually transmitted disease and also the leading infectious cause of blindness in the world.Treatment of C. trachomatis eye infection has involved for a long time. The efficacy of single dose azithromycin has already been demonstrated as effective in the treatment of both trachoma and adult inclusion conjunctivitis.However, in our clinical experience, some patients of chlamydial conjunctivitis may require augmented single dose azithromycin treatments before C. trachomatis is eradicated. In this way, we would like to known the efficacy of single dose and augmented single dose azithromycin in the treatment of chlamydial conjunctivitis.

Detailed description: Medical records of patients with clinically suspected chlamydial conjunctivitis between January 1, 2006 and December 31, 2006 at one cornea specialist's (Y.C.H) out-patient clinic were retrospectively reviewed. At this clinic, patients of both sexes with acute, chronic or recurrent follicular conjunctivitis with the symptoms and signs of chlamydial conjunctivitis suspected were tested for Chlamydia direct fluorescent antibody (DFA) tests and arranged for next time out-patient clinic follow up 1-2 weeks later. The patients who attended the follow up visit with positive DFA results were treated with oral azithromycin. These patients received a single dose oral azithromycin (400mg\~1000mg, according to their age and body weight) once a week for consecutive two weeks. Repeated DFA examinations were performed 4 to 6 weeks later. If the DFA examinations still showed positive results, augmented single dose oral azithromycin once a week for one week was given again till the DFA showed negative results. The occurrence and frequency of adverse events recorded in the medical charts were reviewed as well.

Eligibility criteria: Inclusion Criteria:

* Patients of clinically chlamydial conjunctivitis suspected and proven by direct fluorescent antibody(DFA)results

Exclusion Criteria:

* Patients with pregnancy or lactation, history of allergy to macrolides, evidence or history of hepatic, renal, hematological or cardiovascular disease

Primary outcomes:
measure: Total Number of Participants With Negative Chlamydia Direct Fluorescent Antibody (DFA) Test Results After Oral Azithromycin Treatments
timeFrame: 4 weeks, 8 weeks and 12 weeks after the first dose of the medication
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Yu-Chih Hou, MD
role: STUDY_DIRECTOR
affiliation: National Taiwan University Hospital
name: Fung-Rong Hu, MD
role: STUDY_DIRECTOR
affiliation: National Taiwan University Hospital
name: Yan-Ming Chen, MD
role: PRINCIPAL_INVESTIGATOR
References: