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| Descriptive Information Fields | |||||
| Brief Title † | Trachoma Elimination Follow-up | ||||
| Official Title † | Trachoma Elimination With Repeated Mass Azithromycin Treatments | ||||
| Brief Summary | The WHO has initiated a program to eliminate blinding trachoma by the year 2020, in large part by mass oral azithromycin distributions. It is not clear how frequently or for how long these treatments are necessary. Here we assess the frequency and duration of treatment. |
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| Detailed Description | 40 villages in the Gurage Zone of Ethiopia were randomly assigned to biannual treatment, annual treatment, and a single treatment. Each treatment consisted of a single dose of oral azithromycin to the entire population over the age of 1 year (when the study was started, azithromycin had not yet been approved for ages below 1 year). We assess the prevalence the ocular chlamydia that causes trachoma in the peak prevalence age of 1-5 years at baseline, and 2, 6, 12, 18, and 24 months post treatment. An extension of the study monitors infection at 30 and 36 months post treatment. Untreated villages from the same area are enrolled in a step-wedge design to assess the presence of a secular trend. A random sample of those not within the 1-5 year old age group are examined to assess the prevalence of infection in the entire community. |
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| Study Phase | Phase IV | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Single Blind, Dose Comparison, Single Group Assignment, Efficacy Study | ||||
| Primary Outcome Measure † | The prevalence of ocular chlamydia infection in a village as determined by PCR | ||||
| Secondary Outcome Measure † | Clinical active trachoma, as determined by the WHO simplified grading system, by village | ||||
| Condition † | Trachoma Chlamydia |
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| Intervention † | Drug: Mass treatment with oral azithromycin to an entire village | ||||
| MEDLINE PMIDs | 15304470, 15494901, 17683646, 17255240, 16522834 | ||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Active, not recruiting | ||||
| Enrollment † | 20000 | ||||
| Start Date † | March 2003 | ||||
| Completion Date | April 2005 | ||||
| Eligibility Criteria † | Inclusion Criteria: Age 1 to 5 years old in a village in the Gurage zone with endemic trachoma Exclusion Criteria: Refusal of village chief (for village inclusion), or refusal of parent or guardian (for individual inclusion) |
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| Gender | Both | ||||
| Ages | 1 Year and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | Ethiopia | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00221364 | ||||
| Organization ID | TEF | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | University of California, San Francisco | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | University of California, San Francisco | ||||
| Verification Date | April 2008 | ||||
| First Received Date † | September 14, 2005 | ||||
| Last Updated Date | April 1, 2008 | ||||
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