- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01178762
The Effect of Oral Azithromycin in the Treatment of Chlamydial Conjunctivitis
October 5, 2010 updated by: National Taiwan University Hospital
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
42
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Taipei, Taiwan, 100
- National Taiwan University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Observation
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Oral Azithromycin in the Treatment of Chlamydial Conjunctivitis
Other Names:
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What is the study measuring?
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
Time Frame: 4 weeks, 8 weeks and 12 weeks after the first dose of the medication
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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.
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4 weeks, 8 weeks and 12 weeks after the first dose of the medication
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Yu-Chih Hou, MD, National Taiwan University Hospital
- Study Director: Fung-Rong Hu, MD, National Taiwan University Hospital
- Principal Investigator: Yan-Ming Chen, MD, National Taiwan University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2007
Primary Completion (Actual)
November 1, 2007
Study Completion (Actual)
December 1, 2007
Study Registration Dates
First Submitted
August 31, 2008
First Submitted That Met QC Criteria
August 9, 2010
First Posted (Estimate)
August 10, 2010
Study Record Updates
Last Update Posted (Estimate)
October 27, 2010
Last Update Submitted That Met QC Criteria
October 5, 2010
Last Verified
September 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Eye Diseases
- Gram-Negative Bacterial Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Conjunctival Diseases
- Corneal Diseases
- Chlamydiaceae Infections
- Eye Infections, Bacterial
- Eye Infections
- Chlamydia Infections
- Conjunctivitis, Bacterial
- Conjunctivitis
- Trachoma
- Conjunctivitis, Inclusion
- Anti-Infective Agents
- Anti-Bacterial Agents
- Azithromycin
Other Study ID Numbers
- 200709013R
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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