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Sponsored by: |
University of California, San Francisco |
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Information provided by: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT00221364 |
The WHO has initiated a program to eliminate blinding trachoma by the year 2020, in large part by mass oral azithromycin distributions. It is not clear how frequently or for how long these treatments are necessary. Here we assess the frequency and duration of treatment.
Condition | Intervention | Phase |
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Trachoma Chlamydia |
Drug: Mass treatment with oral azithromycin to an entire village |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Dose Comparison, Single Group Assignment, Efficacy Study |
Official Title: | Trachoma Elimination With Repeated Mass Azithromycin Treatments |
Estimated Enrollment: | 20000 |
Study Start Date: | March 2003 |
Estimated Study Completion Date: | April 2005 |
Estimated Primary Completion Date: | April 2005 (Final data collection date for primary outcome measure) |
40 villages in the Gurage Zone of Ethiopia were randomly assigned to biannual treatment, annual treatment, and a single treatment. Each treatment consisted of a single dose of oral azithromycin to the entire population over the age of 1 year (when the study was started, azithromycin had not yet been approved for ages below 1 year). We assess the prevalence the ocular chlamydia that causes trachoma in the peak prevalence age of 1-5 years at baseline, and 2, 6, 12, 18, and 24 months post treatment. An extension of the study monitors infection at 30 and 36 months post treatment. Untreated villages from the same area are enrolled in a step-wedge design to assess the presence of a secular trend. A random sample of those not within the 1-5 year old age group are examined to assess the prevalence of infection in the entire community.
Ages Eligible for Study: | 1 Year and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Age 1 to 5 years old in a village in the Gurage zone with endemic trachoma
Exclusion Criteria:
Refusal of village chief (for village inclusion), or refusal of parent or guardian (for individual inclusion)
Responsible Party: | Proctor Foundation ( Thomas Lietman, MD ) |
Study ID Numbers: | TEF |
Study First Received: | September 14, 2005 |
Last Updated: | April 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00221364 |
Health Authority: | United States: Institutional Review Board |
Trachoma Chlamydia Azithromycin |
Bacterial Infections Corneal Diseases Eye Infections, Bacterial Conjunctivitis, Bacterial Eye Diseases Eye Infections Conjunctivitis Genital Diseases, Male |
Conjunctival Diseases Trachoma Gram-Negative Bacterial Infections Genital Diseases, Female Azithromycin Chlamydia Infections Sexually Transmitted Diseases |
Anti-Infective Agents Anti-Bacterial Agents Sexually Transmitted Diseases, Bacterial Chlamydiaceae Infections |
Therapeutic Uses Infection Pharmacologic Actions |