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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: | NCT00286026 |
Purpose
Trachoma is the world's leading cause of preventable blindness. This disease, caused by Chlamydia trachomatis, is endemic in many parts of the developing world. In 1990s we evaluated the use of community-wide treatment with oral azithromycin in a project called Azithromycin in Control of Trachoma (ACT).
This approach resulted in clinical improvement and dramatic reduction in prevalence of chlamydial infection through a 1-year follow-up. We enrolled the ACT villages, as well as an additional village that had not had any prior treatments, in our ACT II (2005) study and performed clinical surveys to assess trachoma activity testing conjunctival swabs for the presence of C. trachomatis by nucleic acid amplification tests (NAATs). Thus, we hoped to determine the long-term (10 year) effects of azithromycin treatment.
We have completed the census and clinical survey of the initial three villages. Mass treatment with azithromycin would not be justified with such low rates (1.8 - 4%) of ocular chlamydial infection. We have treated only those living in households with one or more cases of chlamydial infection and we will not follow up on these individually treated families.
In order to achieve the goals of our study, we now propose to identify other more remote villages with trachoma infection rates of 20% or more to evaluate the effect of community-wide treatment with single dose of oral azithromycin. If one or more of these villages (dependent upon population) has trachoma rates of 20% or more they will be invited to participate in the azithromycin treatment. In one set of subjects (1 or 2 villages, dependent upon population and infection rate) we will perform treatment, and follow them up at 2-, 12-, and 24-months post-treatment to ascertain infection rates. In a second set of subjects (1 or 2 villages, dependent upon population and infection rate) we will perform treatment, then perform re-treatment at 30-days post initial treatment, and follow them up at 2-, 12-, and 24-months post-treatment to ascertain infection rates. This should help us determine the need for/and the best time for re-treatment to eliminate blinding trachoma, as some recent studies suggest there is a 2-4% failure rate in the initial treatment. In sum, this study should provide a rational approach to use of community-wide azithromycin treatment to eliminate blinding trachoma as a public health problem
| Condition | Intervention | Phase |
|---|---|---|
|
Trachoma Chlamydia Trachomatis |
Drug: Azithromycin |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Single Blind (Investigator), Active Control, Single Group Assignment, Efficacy Study |
| Estimated Enrollment: | 4500 |
| Study Start Date: | June 2005 |
| Estimated Study Completion Date: | May 2009 |
| Primary Completion Date: | August 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Arm 1: Experimental
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); treated with Azithromycin at Day 30; re-screened (clinical evaluation and swab specimen of R eye collected) at Day 60 and Day 360.
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Drug: Azithromycin
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. One dose vs 2 doses given 30 days apart.
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|
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 initial treatment with Azithromycin; receive a second dose of Azithromycin at Day 30; re-screened (clinical evaluation and swab specimen of R eye collected) at Day 60 and Day 360.
|
Drug: Azithromycin
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. One dose vs 2 doses given 30 days apart.
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Show Detailed Description Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| University of California, San Francisco | |
| San Francisco, California, United States, 94143 | |
| Principal Investigator: | Julius Schachter, PhD | University of California, San Francisco |
| Principal Investigator: | Chandler R Dawson, MD | University of California, San Francisco |
More Information
| Responsible Party: | Univ of CA, San Francisco ( Julius Schachter, PhD ) |
| Study ID Numbers: | H1079-17254 |
| Study First Received: | January 31, 2006 |
| Last Updated: | May 21, 2008 |
| ClinicalTrials.gov Identifier: | NCT00286026 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Trachoma Chlamydia trachomatis |
|
Bacterial Infections Eye Infections, Bacterial Corneal Diseases Conjunctivitis, Bacterial Eye Diseases Eye Infections Conjunctivitis |
Conjunctival Diseases Trachoma Gram-Negative Bacterial Infections Anti-Bacterial Agents Azithromycin Chlamydia Infections |
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Bacterial Infections Anti-Infective Agents Eye Infections, Bacterial Corneal Diseases Conjunctivitis, Bacterial Eye Diseases Eye Infections Conjunctivitis Infection |
Pharmacologic Actions Conjunctival Diseases Trachoma Gram-Negative Bacterial Infections Anti-Bacterial Agents Chlamydiaceae Infections Therapeutic Uses Azithromycin Chlamydia Infections |
