A Phase 4 interventional study of Azithromycin in Trachoma, sponsored by University of California, San Francisco. Withdrawn at 1 site in United States. Per ClinicalTrials.gov, last updated 2012-04-16.
Sponsored by University of California, San Francisco · Phase 4, Interventional, and Treatment
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
This is operational research aimed at better defining the use of oral azithromycin as part of the SAFE strategy to eliminate blinding trachoma.
After the results are obtained from the nucleic acid amplification testing performed at the laboratory in San Francisco, treatment for trachoma will be done with a single-dose of oral azithromycin (20 mg/kg body weight in children, 1.0 gm adults). The azithromycin will be donated by Pfizer International. Young children will be weighed to determine the dose of azithromycin and the doses administered by a health aide under direct supervision of an Egyptian physician (Dr. Mahfouz). One set of subjects (1 or 2 villages depending upon population size, in order to generate meaningful numbers) will receive an initial treatment of 1.0 gm azithromycin; while the second set of subjects will receive an initial treatment of 1.0 gm azithromycin, followed by a second dose of 1.0 gm azithromycin at 30 days post treatment.
If the prevalence of clinical trachoma is over 20% in children 10 and under, everyone in the village will be treated with oral azithromycin.
After initial azithromycin treatment, follow-up examinations and specimen collection will be done 2, 12, and 24 months post-treatment for trachoma and chlamydial infection.
If the prevalence is 10% to 20%, all children 10 and under, and the families of those children with active trachoma, will be treated.
After initial azithromycin treatment, follow-up examinations and specimen collection will be done 2, 12, and 24 months post-treatment for trachoma and chlamydial infection.
Adults and older children will be told that azithromycin can cause nausea, vomiting, or loose stools or vomiting in some children and adults, and can occur in up to 5% (1 person in 20) of those treated.
It should be noted that in our previous ACT study, more than 8,000 people received azithromycin with no complaints beyond minor gastro-intestinal upset.
39 studies on the registry are indexed under Trachoma; 3 are open to participants now.
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Exclusion Criteria:
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); will be treated with Azithromycin at Day 30; will be re-screened (clinical evaluation and swab specimen of R eye collected) at Day 60; and again at Day 360.
Drug: Azithromycin
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 Azithromycin; will receive a second dose of Azithromycin at Day 30; will be re-screened (clinical evaluation and swab specimen of R eye collected) at Day 60; and again at 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.
Also known as: Zithromax, Zmax
Infection with Chlamydia trachomatis diagnosed by use of NAAT
Time frame: One-year
The record gives a start of Jun 2005, a primary completion of Aug 2007 and a completion of Aug 2009. It does not say whether these dates are actual or estimated.
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This study is withdrawn, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Azithromycin
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