The Effect of Oral Azithromycin in the Treatment of Chlamydial Conjunctivitis

Chlamydial Conjunctivitis Clinical Trial

Official title:

The Effect of Oral Azithromycin in the Treatment of Chlamydial Conjunctivitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01178762
• Other study ID #: 200709013R
• Status: Completed
• Phase: N/A
• First received: August 31, 2008
• Last updated: October 5, 2010
• Start date: September 2007
• Est. completion date: December 2007

Study information

• Verified date: September 2010
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: December 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chlamydial Conjunctivitis
• Conjunctivitis

Intervention

Drug:
• Azithromycin
Oral Azithromycin in the Treatment of Chlamydial Conjunctivitis

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No

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