The Effect of Oral Azithromycin in the Treatment of Chlamydial Conjunctivitis

This study has been completed.
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01178762
First received: August 31, 2008
Last updated: October 5, 2010
Last verified: September 2010

August 31, 2008
October 5, 2010
September 2007
November 2007   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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.
negative Chlamydia direct fluorescent antibody (DFA) test results [ Time Frame: 4 weeks 8 weeks and 12 weeks later ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01178762 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
The Effect of Oral Azithromycin in the Treatment of Chlamydial Conjunctivitis
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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Chlamydial Conjunctivitis
Drug: Azithromycin
Oral Azithromycin in the Treatment of Chlamydial Conjunctivitis
Other Name: zithromax(Pfizer)
Experimental: Observation
Intervention: Drug: Azithromycin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
December 2007
November 2007   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT01178762
200709013R
Yes
Yan-Ming Chen / Yu-Chih Hou, National Taiwan University Hospital
National Taiwan University Hospital
Not Provided
Study Director: Yu-Chih Hou, MD Department of Ophthalmology, National Taiwan University Hospital
Study Director: Fung-Rong Hu, MD Department of Ophthalmology, National Taiwan University Hospital
Principal Investigator: Yan-Ming Chen, MD Department of Ophthalmology, National Taiwan University Hospital
National Taiwan University Hospital
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP