The Effect of Oral Azithromycin in the Treatment of Chlamydial Conjunctivitis
Primary Purpose
Chlamydial Conjunctivitis
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Azithromycin
Sponsored by
About this trial
This is an interventional treatment trial for Chlamydial Conjunctivitis focused on measuring Oral Azithromycin, Chlamydial Conjunctivitis
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
Sites / Locations
- National Taiwan University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Observation
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01178762
First Posted
August 31, 2008
Last Updated
October 5, 2010
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01178762
Brief Title
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
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chlamydial Conjunctivitis
Keywords
Oral Azithromycin, Chlamydial Conjunctivitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Observation
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Azithromycin
Other Intervention Name(s)
zithromax(Pfizer)
Intervention Description
Oral Azithromycin in the Treatment of Chlamydial Conjunctivitis
Primary Outcome Measure Information:
Title
Total Number of Participants With Negative Chlamydia Direct Fluorescent Antibody (DFA) Test Results After Oral Azithromycin Treatments
Description
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.
Time Frame
4 weeks, 8 weeks and 12 weeks after the first dose of the medication
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yu-Chih Hou, MD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Fung-Rong Hu, MD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Yan-Ming Chen, MD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
12. IPD Sharing Statement
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/19893589
Description
Publication provided
Learn more about this trial
The Effect of Oral Azithromycin in the Treatment of Chlamydial Conjunctivitis
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