A Phase 4 interventional study of Mass treatment with oral azithromycin to an entire community 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, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-09-09.
Sponsored by University of California, San Francisco · Phase 4, Interventional, and Treatment
The WHO has initiated a program to eliminate trachoma, blinding eye infection caused by Chlamydia trachomatis, in large part by mass distributions of oral azithromycin. The proposed study will determine the frequency and treatment target of community-wide mass antibiotic treatment. We will also study the impact of mass antibiotic distribution on antibiotic-resistance in pneumococcus.
The proposed study is a group-randomized trial to determine the frequency and treatment target of community-wide mass antibiotic treatment to eliminate trachoma. We will also study the impact of community-wide antibiotic distribution on antibiotic-resistance in pneumococcus. Communities in Goncha Siso Enese district of East Gojam Zone, Ethiopia will be randomly assigned to different treatment schemes and monitored to study the following research questions:
Specific Aim 1. To determine whether biannual mass treatments is more likely to eliminate ocular chlamydia from hyper-endemic communities than annual mass treatments.
Specific Aim 2. To determine whether children form a core group for the transmission of trachoma.
Specific Aim 3. To determine whether latrine construction prevents the return of infection into a community after mass treatment.
Specific Aim 4. To determine the effect of mass azithromycin treatments on antibiotic resistance in pneumococcus and the reduction in mortality.
Specific Aim 5. To determine whether annual mass treatments are more likely to eliminate ocular chlamydia from hyper-endemic communities than biennial mass treatments.
39 studies on the registry are indexed under Trachoma; 3 are open to participants now.
This study's enrollment of 33,000 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.
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Exclusion Criteria:
Individuals in these three exclusion criteria will not be given the study antibiotic azithromycin, but offered the current WHO-recommended alternative treatment to azithromycin for active trachoma, which is 1% tetracycline eye ointment, to be used twice a day, topically to both eyes, for six weeks. Note that the exclusion criteria refer to the exclusion to the treatment drug, but not to the monitoring, treatment of trachoma, and examinations.
Annual mass treatment
Drug: Mass treatment with oral azithromycin to an entire community
Biannual mass treatment
Drug: Mass treatment with oral azithromycin to an entire community
Mass administration of antibiotic; treatment of children (1-10 years of age) only
Drug: Mass treatment with oral azithromycin to an entire community
Delayed initiation of mass administration of antibiotic
One-time mass administration only
Drug: Mass treatment with oral azithromycin to an entire community
One-time mass administration of antibiotics, plus intensive latrine construction
Drug: Mass treatment with oral azithromycin to an entire community
For baseline and follow-up surveys prior to azithromycin distribution, a stratified random sample from two age groups will be chosen: 1) 60 study participants younger than 10 years old and 2) 60 study participants aged 10 years and above. Clinical examination will be performed and conjunctival swabs will be taken from all the study participants. For study arm C and D, nasopharyngeal swabs will be collected from 10 randomly selected children among the 60 participants under 10 who were recruited for conjunctival swabbing. Then a single dose of azithromycin will be distributed according to study design: in tablet form for adults; a weight-adjusted tablet dose for children ages 8-10; and pediatric suspension for children ages 1 - 7.
The average prevalence of ocular chlamydia infection in communities in an arm as determined by pooled NAAT (Nucleic Acid Amplification Test)(at 42 months for Aim 1, at 12 months for Aim 2, post-treatment relative to pre-treatment for Aim 3)
Time frame: 42 months
Clinical active trachoma in community, as determined by the WHO simplified grading system
Time frame: 42 months
Childhood (>= 1 year of age) mortality, analyzed as 1-5, 6-10 years of age, and total
Time frame: 42 months
Macrolide resistance in pneumococcus (% resistance over time, clustered by randomization unit)
Time frame: 42 months
Average prevalence of ocular chlamydia infection in annually and biennially treated communities as determined by pooled NAAT (Nucleic Acid Amplification Test)
Time frame: 48 months
Diversity measure in the conjunctival and nasopharyngeal microbiomes of children (age 0-9)
Time frame: 0, 6, 12, 18, 24, 30, 36, 42, and 48 months
This study is completed, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.
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