Trachoma Elimination Follow-up (TEF)
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Purpose
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 |
|---|---|---|
|
Trachoma Chlamydia |
Drug: Mass treatment with oral azithromycin to an entire village |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind Primary Purpose: Treatment |
| Official Title: | Trachoma Elimination With Repeated Mass Azithromycin Treatments |
- The prevalence of ocular chlamydia infection in a village as determined by PCR
- Clinical active trachoma, as determined by the WHO simplified grading system, by village
| Estimated Enrollment: | 20000 |
| Study Start Date: | March 2003 |
| Study Completion Date: | April 2005 |
| 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.
Eligibility| 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)
Contacts and Locations More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Thomas M. Lietman, Professor, University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT00221364 History of Changes |
| Other Study ID Numbers: | 10-02630 |
| Study First Received: | September 14, 2005 |
| Last Updated: | May 20, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of California, San Francisco:
|
Trachoma Chlamydia Azithromycin |
Additional relevant MeSH terms:
|
Chlamydia Infections Trachoma Chlamydiaceae Infections Gram-Negative Bacterial Infections Bacterial Infections Sexually Transmitted Diseases, Bacterial Sexually Transmitted Diseases Infection Genital Diseases, Male Genital Diseases, Female Conjunctivitis, Bacterial |
Eye Infections, Bacterial Eye Infections Conjunctivitis Conjunctival Diseases Eye Diseases Corneal Diseases Azithromycin Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013