Trachoma Clinical Trial
Official title:
Impact of Two Alternative Dosing Strategies for Trachoma Control in Niger
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 adults. Infection is more widespread. It is anticipated that 25% of the
children will be blinded by this disease if they live to be 60 years of age. The blindness
rates are higher in women, presumably because of their closer contact with children who can
infect them and add to damage from infections the women had while young.
This proposal is to better define how azithromycin in community-based treatment can be used
to eliminate blinding trachoma. We will also take the opportunity to join these field
studies with genetic epidemiologic studies to better understand the dynamic epidemiology of
Chlamydia trachomatis infection in a trachoma endemic area. The empiric data generated from
the treatment/follow-up studies, together with the information on sources and spread
patterns from genetic epidemiology will be used to generate more robust models to guide
future treatment/re-treatment protocols.
We propose to conduct a randomized, community based trial in the Maradi region of Niger to
test the hypothesis that two community wide azithromycin treatments, spaced one month apart,
are significantly more effective in reducing ocular C. trachomatis infection and trachoma at
one year compared to a single mass azithromycin treatment.
Status | Completed |
Enrollment | 1139 |
Est. completion date | August 2009 |
Est. primary completion date | May 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | N/A and older |
Eligibility |
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. Inclusion Criteria: - To be eligible to participate in this study the subject must live in one of the villages selected for this study. Exclusion Criteria: - 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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Niger | Programme National de Lutte Contre la Cécité | Niamey | |
United States | Chlamydia Research Laboratory | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco | National Institute of Allergy and Infectious Diseases (NIAID) |
United States, Niger,
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* Note: There are 20 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Infection With Chlamydia Trachomatis Diagnosed by Use of NAATs [Nucleic Acid Amplification Test] | 1-year post-treatment | No |
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