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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00618449 |
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Date of registration:
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06/02/2008 |
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Primary sponsor: |
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Public title:
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Impact of Two Alternative Dosing Strategies for Trachoma Control in Niger
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Scientific title:
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Impact of Two Alternative Dosing Strategies for Trachoma Control in Niger |
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Date of first enrolment:
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January 2008 |
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Target sample size:
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1139 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00618449 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
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Countries of recruitment
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Niger
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United States
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Contacts
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Name:
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Abdou Amza, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Programme National de Lutte Contre la Cécité |
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Name:
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Julius Schachter, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of California, San Francisco |
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Key inclusion & exclusion criteria
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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
Age minimum:
N/A
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Chlamydia Trachomatis
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Trachoma
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Intervention(s)
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Drug: Azithromcyin
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Drug: Azithromycin
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Primary Outcome(s)
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Infection With Chlamydia Trachomatis Diagnosed by Use of NAATs [Nucleic Acid Amplification Test]
[Time Frame: 1-year post-treatment]
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Secondary ID(s)
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5R01AI048789
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H1079-31932
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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