The Effect of Oral Azithromycin in the Treatment of Chlamydial Conjunctivitis

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect of Oral Azithromycin in the Treatment of Chlamydial Conjunctivitis

Conditions
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Chlamydial Conjunctivitis

Intervention / Treatment
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* Drug: Azithromycin


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Observation<br> | Drug: Azithromycin<br>* Oral Azithromycin in the Treatment of Chlamydial Conjunctivitis<br>* Other names: zithromax(Pfizer);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Number of Participants With Negative Chlamydia Direct Fluorescent Antibody (DFA) Test Results After Oral Azithromycin Treatments | We performed direct fluorescent antibody (DFA) tests for Chlamydia by swabbing across the lower and upper tarsal conjunctiva four times after topical application of 0.5% proparacaine. All of the DFA tests were examined by the same experienced microbiologist who was masked to the identities and clinical conditions of the patients. Each DFA slide was read under a fluorescent microscope and was observed for discrete fluorescent chlamydial elementary bodies (EBs).The DFA test was considered positive if above 10 EBs were counted per high-power field. | 4 weeks, 8 weeks and 12 weeks after the first dose of the medication | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oral Azithromycin, Chlamydial Conjunctivitis