A Phase 4 interventional study of mass treatment with oral azithromycin in Trachoma and Chlamydia, sponsored by University of California, San Francisco. Completed at 1 site in Ethiopia. Open to participants aged 1 Day and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-10-11.
Sponsored by University of California, San Francisco · Phase 4, Interventional, and Treatment
Mass antimicrobial administrations have been remarkably successful in reducing the prevalence of the ocular strains of Chlamydia that cause trachoma. Repeated distributions progressively lower the prevalence of infection, and in some cases may even result in local elimination. Mass treatments cannot be continued forever, due to concerns about cost and antibiotic resistance. The hope has been that other measures such as latrine construction and hygiene programs would prevent infection from returning. Unfortunately, no non-antibiotic measure has yet demonstrated an effect on infection.
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 continue to monitor a sub-set of communities from our TANA study, in Goncha Siso Enese district of East Gojam Zone, Ethiopia. Here we evaluate how infection returns when antibiotics are discontinued, whether infection can be predictably eliminated, and whether infection can be prevented from returning with targeted treatment strategies:
Specific Aim 1. To determine whether antibiotics can be stopped after 4 years.
Specific Aim 2. To determine whether infection can be completely eliminated if mass treatments continue for seven years.
Specific Aim 3. To determine whether treatment targeted to pre-school aged children, or to households in which a pre-school aged child has clinically active trachoma, will prevent infection from returning into the community.
Specific Aim 4: To determine whether mass azithromycin distributions reduce visits to local health clinics due to all causes and infectious causes.
Specific Aim 5: To determine whether mass azithromycin distributions result in better growth metrics (weight-for-height, height-for age, weight-for-age, middle upper arm circumference) compared to no treatment.
Specific Aim 6: To determine whether under-5 mortality is lower in communities treated with mass azithromycin compared to no treatment
Specific Aim 7: To determine whether macrolide resistance in Streptococcus pneumoniae, Hameophilus influenzae, and Staphylococcus aureus is more prevalent in communities treated with biannual mass azithromycin compared to communities treated with annual mass azithromycin, and to determine whether targeted azithromycin treatments result in less macrolide resistance compared to mass azithromycin distributions.
39 studies on the registry are indexed under Trachoma; 3 are open to participants now.
This study's enrollment of 29,000 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.
Stop Annual Treatment
Stop Biannual Treatment
Continue Annual Treatment
Drug: mass treatment with oral azithromycin
Continue Biannual Treatment
Drug: mass treatment with oral azithromycin
Targeted Treatment by Age
Drug: mass treatment with oral azithromycin
Targeted Treatment by Clinical Exam
Drug: mass treatment with oral azithromycin
Drug page: Azithromycin
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. Nasopharyngeal swabs will be collected in each community from 15 randomly selected children among the 60 participants under age 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.
Also known as: Zithromax
The average prevalence of ocular chlamydia infection in communities in an arm as determined by pooled NAAT (Nucleic Acid Amplification Test)(at 36 months versus 0 months for Aim 1, at 36 months for Aim 2 and Aim 3)
Time frame: 36 months
Clinical active trachoma in community, as determined by the WHO simplified grading system
Time frame: 36 months
Childhood mortality (6 months -5 years of age), 6-10 years of age, and >10 years
Time frame: 36 months
Macrolide resistance in pneumococcus, Haemophilus influenzae, and Staphylococcus aureus (% resistance over time, clustered by randomization unit)
Time frame: 36 months
Anthropometric measurements (weight and height), as outlined by WHO child growth standards (0-5 years of age)
Time frame: 3, 12, 24, and 36 months after baseline
Health clinic visits (due to all causes and due to infectious causes) in children aged 6 months-5 years, 6-10 years, and >10 years
Time frame: 36 months
Prevalence of anemia (hemoglobin levels in 0-9 year olds) and the prevalence of malaria
Time frame: 36 months
Clinically active trachoma in a school (all children under age 10), as determined by the WHO simplified grading system
Time frame: 36 months
Cost-effectiveness of mass azithromycin administration, per infection year prevented and cost per eliminated village
Time frame: 0, 12, 24, and 36 months
Estimate of chlamydial load from real-time, qPCR
Time frame: 0, 12, 24, 36 months
The record gives a start of Nov 2010, a primary completion of Nov 2013 and a completion of May 2014. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Oct 2017. 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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