Impact of Two Alternative Dosing Strategies for Trachoma Control in Niger
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00618449|
Recruitment Status : Completed
First Posted : February 20, 2008
Results First Posted : May 8, 2012
Last Update Posted : May 8, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Trachoma Chlamydia Trachomatis||Drug: Azithromcyin Drug: Azithromycin||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1139 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Impact of Two Alternative Dosing Strategies for Trachoma Control in Niger|
|Study Start Date :||January 2008|
|Actual Primary Completion Date :||May 2009|
|Actual Study Completion Date :||August 2009|
Experimental: Arm 2
Subjects residing in villages assigned to treatment arm 2 will receive a clinical evaluation for trachoma and provide a swab specimen of conjunctivae of the R eye at enrollment (Day 0), as well as receive an initial treatment with 1 gm oral dose of Azithromycin; receive a second 1 gm oral dose of Azithromycin at Day 30; be re-screened (clinical evaluation and swab specimen of R eye collected) at Day 60 and Day 360.
1 gm Azithromycin orally, provided as four 250 mg tablets for adults; pediatric suspension will be provided to children > 1 year old (20 mg/kg body weight) to a maximal dose of 500 mg - Given 30 days apart; at Day 0 & Day 30 for a total of 2 doses.
Active Comparator: Arm 1
Subjects residing in villages assigned to treatment arm 1 will receive a clinical evaluation for trachoma and provide a swab specimen of conjunctivae of the R eye at enrollment (Day 0); be treated at Day 30 with the WHO standard of care for trachoma - 1 gm oral dose of Azithromycin; be re-screened (clinical evaluation and swab specimen of R eye collected) at Day 60 and Day 360.
1 gm Azithromycin orally, provided as four 250 mg tablets for adults; pediatric suspension will be provided to children > 1 year old (20 mg/kg body weight) to a maximal dose of 500 mg - Given at Day 30 for a total of 1 dose.
- Infection With Chlamydia Trachomatis Diagnosed by Use of NAATs [Nucleic Acid Amplification Test] [ Time Frame: 1-year post-treatment ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00618449
|United States, California|
|Chlamydia Research Laboratory|
|San Francisco, California, United States, 94110|
|Programme National de Lutte Contre la Cécité|
|Principal Investigator:||Julius Schachter, PhD||University of California, San Francisco|
|Study Director:||Abdou Amza, MD||Programme National de Lutte Contre la Cécité|