A Phase 4 interventional study of Mass treatment with oral azithromycin to an entire village in Trachoma and Chlamydia, sponsored by University of California, San Francisco. Completed at 1 site in Ethiopia. Open to participants aged 1 Year and older. Per ClinicalTrials.gov, last updated 2015-07-15.
Sponsored by University of California, San Francisco · Phase 4, Interventional, and Treatment
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.
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.
39 studies on the registry are indexed under Trachoma; 3 are open to participants now.
This study's planned enrollment of 20,000 is above the median of 1,300 across 31 interventional studies indexed under Trachoma.
Browse Trachoma studies →University of California, San Francisco is the lead sponsor of 2,169 studies on the registry; 372 are open to participants now.
Of its 267 completed or terminated interventional studies of FDA-regulated products, 202 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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)
The prevalence of ocular chlamydia infection in a village as determined by PCR
Clinical active trachoma, as determined by the WHO simplified grading system, by village
The record gives a start of Mar 2003, a primary completion of Apr 2005 and a completion of Apr 2005. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of California, San Francisco →