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Impact of Two Alternative Dosing Strategies for Trachoma Control in Niger
NCT00618449 · View on ClinicalTrials.gov ↗
Study 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 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.
Conditions Studied
Interventions
- DRUG Azithromycin
- DRUG Azithromcyin
Study Locations (2)
California
- Chlamydia Research Laboratory — San Francisco
Other
- Programme National de Lutte Contre la Cécité — Niamey
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,139 participants |
| Start Date | 2008-01 |
| Est. Completion | 2009-08 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00618449
The ClinicalTrials.gov registry entry for NCT00618449 describes a study currently listed as completed. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,139 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Francis, which has 1,574 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Trachoma appearing as the primary indexed condition, and to 2 interventions — of which Azithromycin is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00618449 reports 2 study locations spanning 2 distinct geographic areas — top geographies include California, Other. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00618449 about?
NCT00618449 is a clinical study titled "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...
What is the current status of trial NCT00618449?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 1,139 participants. The study started on 2008-01. Estimated completion is 2009-08.
What conditions does trial NCT00618449 study?
This clinical trial studies the following conditions: Trachoma, Chlamydia Trachomatis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00618449?
The interventions under investigation include: Azithromycin (DRUG), Azithromcyin (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00618449?
This trial is sponsored by University of California, San Francis, which has 1,574 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00618449 being conducted?
This trial has 2 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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