The Effect of Oral Azithromycin in the Treatment of Chlamydial Conjunctivitis

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.

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Key information

Conditions

Chlamydial Conjunctivitis Bacterial Infections Bacterial Infections and Mycoses Chlamydia Infections Chlamydiaceae Infections Conjunctival Diseases Conjunctivitis Conjunctivitis, Bacterial Conjunctivitis, Inclusion Eye Diseases Eye Infections Eye Infections, Bacterial Gram-Negative Bacterial Infections Infections

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital

Taipei, 100, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Azithromycin

Drug

Oral Azithromycin in the Treatment of Chlamydial Conjunctivitis

Other names: zithromax(Pfizer)

Primary outcomes

Total Number of Participants With Negative Chlamydia Direct Fluorescent Antibody (DFA) Test Results After Oral Azithromycin Treatments

Time frame: 4 weeks, 8 weeks and 12 weeks after the first dose of the medication

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.

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Important dates

Study start: 2007
Primary completion: 2007
Study completion: 2007
First posted: Aug 10, 2010
Registry last updated: Oct 27, 2010

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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