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| Sponsors and Collaborators: |
University of California, San Francisco National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Information provided by: | University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT00618449 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Trachoma Chlamydia Trachomatis |
Drug: Azithromcyin |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Impact of Two Alternative Dosing Strategies for Trachoma Control in Niger |
| Estimated Enrollment: | 1400 |
| Study Start Date: | January 2008 |
| Estimated Study Completion Date: | March 2009 |
| Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Arm 2: Experimental
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.
|
Drug: Azithromcyin
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.
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Arm 1: Active Comparator
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.
|
Drug: Azithromcyin
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.
|
Show Detailed Description Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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:
Exclusion Criteria:
All subjects meeting any of the exclusion criteria will be excluded from study participation. Exclusion criteria include:
Contacts and Locations| Contact: Abdou Amza, MD | +227 752906 | pnlcc@intnet.ne |
| Contact: Julius Schachter, PhD | 415 824 5115 | Julius.Schachter@ucsf.edu |
| United States, California | |
| Chlamydia Research Laboratory | Recruiting |
| San Francisco, California, United States, 94110 | |
| Contact: Julius Schachter, PhD 415-824-5115 Julius.Schachter@ucsf.edu | |
| Niger | |
| Programme National de Lutte Contre la Cécité | Recruiting |
| Niamey, Niger | |
| Contact: Abdou Amza, MD +227 752906 pnlcc@intnet.ne | |
| Principal Investigator: Abdou Amza, MD | |
| Principal Investigator: | Julius Schachter, PhD | University of California, San Francisco |
| Study Director: | Abdou Amza, MD | Programme National de Lutte Contre la Cécité |
More Information
| Responsible Party: | University of California, San Francisco ( Julius Schachter, PhD ) |
| Study ID Numbers: | H1079-31932, 5R01 AI48789 |
| Study First Received: | February 6, 2008 |
| Last Updated: | March 16, 2009 |
| ClinicalTrials.gov Identifier: | NCT00618449 History of Changes |
| Health Authority: | United States: Institutional Review Board; Niger: Institutional Review Board |
|
Trachoma Chlamydia trachomatis |
|
Bacterial Infections Corneal Diseases Eye Infections, Bacterial Conjunctivitis, Bacterial Azithromycin Eye Diseases |
Eye Infections Chlamydia Infections Conjunctivitis Conjunctival Diseases Gram-Negative Bacterial Infections Trachoma |
|
Bacterial Infections Eye Infections, Bacterial Corneal Diseases Conjunctivitis, Bacterial Eye Diseases Eye Infections Conjunctivitis |
Infection Conjunctival Diseases Trachoma Gram-Negative Bacterial Infections Chlamydiaceae Infections Chlamydia Infections |
