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NCT00618449 · ClinicalTrials.gov registry record · Phase 4

Impact of Two Alternative Dosing Strategies for Trachoma Control in Niger

A Phase 4 study of Trachoma and Chlamydia Trachomatis, sponsored by University of California, San Francisco.

Completed
Registry status
Phase 4
Development phase
1,139
Enrollment target
2
Study locations

NCT00618449: Completed Phase 4 study of Trachoma and Chlamydia Trachomatis, sponsored by University of California, San Francisco.

NCT00618449 is a Phase 4 study of Trachoma and Chlamydia Trachomatis that has completed, run by University of California, San Francisco. The registered enrollment target is 1,139 participants, below the 80,281-participant average among 4 other Trachoma trials with a reported enrollment target (99% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00618449, a Phase 4 study of Trachoma and Chlamydia Trachomatis, has completed, sponsored by University of California, San Francisco.

COMPLETED
Registry status
Phase 4
Development phase
1,139 participants
Enrollment target
2
Study locations

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.

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

FieldValue
Enrollment Target 1,139 participants
Start Date 2008-01
Est. Completion 2009-08
Phase Phase 4

What the finished NCT00618449 record still lists

NCT00618449 is an interventional study that assigns participants to a tested intervention. Its 1,139 participants enrollment target places it among the larger protocols in the corpus, below the 80,281-participant average among 4 other Trachoma trials with a reported enrollment target (99% lower).

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.

NCT00618449 reports a single indexed study location in California, Other.

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.

What interventions are being tested in trial NCT00618449?

The interventions under investigation include: Azithromycin (DRUG), Azithromcyin (DRUG).

Who is sponsoring clinical trial NCT00618449?

This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.

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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Source: ClinicalTrials.gov NCT00618449, the US trial registry maintained by the National Library of Medicine. NCT00618449 (large enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.