Status:
COMPLETED
Impact of Two Alternative Dosing Strategies for Trachoma Control in Niger
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Trachoma
Chlamydia Trachomatis
Eligibility:
All Genders
Phase:
PHASE4
Brief Summary
Trachoma is a disease of poverty, which in the hyperendemic areas affects all individuals by the time they are two years old. Active disease is concentrated in children and occurs sporadically in adul...
Detailed Description
Population We will take advantage of the ongoing work in the ten villages currently being studied in Kornaka West. They have never had mass treatment with azithromycin, and the baseline trachoma and ...
Eligibility Criteria
Inclusion
- Subjects live in a village in Niger that exhibits a high prevalence of clinically active trachoma (\>15%) amongst the children living in that village. This prevalence of clinical disease is a marker for much higher infection rates, thus justifying community wide treatment.
- To be eligible to participate in this study the subject must live in one of the villages selected for this study.
Exclusion
- All subjects meeting any of the exclusion criteria will be excluded from study participation. Exclusion criteria include:
- history of allergy to ANY macrolide antibiotic
- severe nausea or diarrhea after the first dose of azithromycin
- inability to tolerate oral therapy
- pre-existing serious illness
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
1139 Patients enrolled
Trial Details
Trial ID
NCT00618449
Start Date
January 1 2008
End Date
August 1 2009
Last Update
May 8 2012
Active Locations (2)
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1
Chlamydia Research Laboratory
San Francisco, California, United States, 94110
2
Programme National de Lutte Contre la Cécité
Niamey, Niger