A Phase 4 interventional study of Azithromycin and Azithromycin in Trachoma, sponsored by Johns Hopkins University. Completed at 3 sites in 2 countries. Open to participants aged Up to 5 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-07-18.
Sponsored by Johns Hopkins University · Phase 4, Interventional, and Treatment
Trachoma, an ocular infection caused by C. trachomatis, is the second leading infectious cause of blindness worldwide. Years of repeated infection with C. trachomatis cause the eyelid to scar and contract and ultimately to rotate inward such that the eyelashes rub against the eyeball and abrade the cornea (trichiasis). The World Health Organization (WHO) has endorsed a multi-faceted strategy to combat trachoma, which includes the use of antibiotic treatment to reduce the community pool of infection with C. trachomatis. The objective of this study is to conduct a randomized, community-based trial in three countries (Niger, Tanzania and The Gambia), representing different baseline endemicities, of alternative coverages and frequencies of administration of mass antibiotic treatment as well as to determine the cost-effectiveness of these different strategies from a program perspective.
A randomized, 2x2 factorial designed trial will be implemented in each of the three countries. Communities will be randomized to two different coverage targets (80%-89% versus ≥90%) for three years of mass treatment.
In The Gambia and Tanzania, communities will be further randomized to yearly mass treatment versus mass treatment at baseline followed by yearly mass treatment only if trachoma prevalence in sentinel children is greater than 5%. The communities will continue to be followed and treatment will resume if trachoma prevalence is found to be 20% or greater at the 12 or 18 month surveys.
In Niger, communities will be randomized to the different coverage levels for annual mass azithromycin distribution and further randomized to biannual treatment at the two coverage targets for children ages twelve or younger.
Cross-sectional rates of trachoma and infection will be determined by examining sentinel children, age five years or younger, randomly selected from each community based on a community census. The census will be updated each year, and villages will be monitored at baseline, 6, 12, 18, 24, 30, and 36 months for infection and clinical disease.
The three-year study is in accord with the WHO guidelines which recommend three years of annual mass treatment followed by a re-survey to determine need for further treatment. The investigators will evaluate the efficacy of guiding further mass treatment according to a laboratory test for Chlamydia or WHO guidelines. Where investigators estimate communities have infection rates less than 5% in sentinel children, or trachomatous inflammation (TF) ( rates less than 5%, the community will be "graduated" from further mass treatment and followed for up to three years to look for evidence of re-emergent infection and disease. If rates of infection are found to be 20% or more return at the 12 or 18 month survey, mass treatment will be re-initiated.
39 studies on the registry are indexed under Trachoma; 3 are open to participants now.
This study's enrollment of 128 is below the median of 1,300 across 31 interventional studies indexed under Trachoma.
Browse Trachoma studies →Johns Hopkins University is the lead sponsor of 1,815 studies on the registry; 315 are open to participants now.
Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion criteria for communities:
If a community meets the inclusion criteria and community leaders consent to have the community enrolled, then sentinel children will be selected based on the following criteria:
Selected communities will receive mass treatment annually for three years.
Drug: Azithromycin
Selected communities will receive mass treatment annually for three years.
Drug: Azithromycin
Treatment to be administered at baseline then continued yearly if trachoma prevalence is greater than 5% In Niger, treatment will be every 6-months for children ages twelve and under.
Drug: Azithromycin
Treatment to be administered at baseline then continued yearly if trachoma prevalence is greater than 5% In Niger, treatment will be every 6-months for children ages twelve and under.
Drug: Azithromycin
Comparison of community coverage rate
Also known as: Zithromax
Comparison of coverage levels at baseline treatment followed by annual treatment if prevalence of trachoma is \>5%. In Niger, there will be a comparison of coverage levels in everyone versus in children ages twelve and under who are treated every 6-months.
Also known as: Zithromax
Community Prevalence of Trachoma and Ocular C. Trachomatis (CT) Infection at Baseline
Mass drug administration (MDA) with azithromycin or topical tetracycline is recommended by World Health Organization (WHO) for 3 years in districts where the prevalence of trachoma is\>=10 % in children aged 1-9 years. The prevalence of trachoma (TF) was measured using the Simplified WHO Grading System. Both eyelids were everted and tarsal conjunctiva graded for signs of clinical trachoma. Ocular photographs of right eye were taken on random samples of sentinel children to determine the drift in grading over time. To detect CT infection, an ocular swab of the right eye using a Dacron swab was collected from the sentinel kids. The swab was stored dry, and frozen until shipped and processed in the laboratory. Air control swabs were also taken to test for field and laboratory contamination.
Time frame: At baseline
Community Prevalence of Trachoma and Ocular C. Trachomatis (CT) Infection at 36 Months
100 random sentinel children aged 0- 5 years per community were to be examined for prevalence of trachoma \& CT infection in Tanzania \& Gambia. 50-100 random sentinel children aged 0-5 years per community were to be examined in Niger per community for prevalence of TF and CT infection. Outcomes are reported at the community level because raw data could not be accessed. There is no way to determine how many participants were examined in each arm.
Time frame: 3 years
The study recruited communities with trachoma rates 20 % or higher from 3 countries - Tanzania, Gambia and Niger. Protocol Enrollment refers to the number of communities, not the number of participants enrolled. The final analysis was done at community level.
| Milestone | ≥90% Coverage With Azithromycin Target | 80%-89% Coverage With Azithromycin Target | ≥90% Coverage With Azithromycin , Treatment Based | 80%-89% Coverage With Azithromycin : Treatment Based |
|---|---|---|---|---|
| Started | NA | NA | NA | NA |
| Niger | NA | NA | NA | NA |
| Gambia | NA | NA | NA | NA |
| Tanzania | NA | NA | NA | NA |
| Completed | NA | NA | NA | NA |
| Not completed | NA | NA | NA | NA |
| Milestone | ≥90% Coverage With Azithromycin Target | 80%-89% Coverage With Azithromycin Target | ≥90% Coverage With Azithromycin , Treatment Based | 80%-89% Coverage With Azithromycin : Treatment Based |
|---|---|---|---|---|
| Started | NA | NA | NA | NA |
| Niger | NA | NA | NA | NA |
| Gambia | NA | NA | NA | NA |
| Tanzania | NA | NA | NA | NA |
| Completed | NA | NA | NA | NA |
| Not completed | NA | NA | NA | NA |
Mass drug administration (MDA) with azithromycin or topical tetracycline is recommended by World Health Organization (WHO) for 3 years in districts where the prevalence of trachoma is\>=10 % in children aged 1-9 years. The prevalence of trachoma (TF) was measured using the Simplified WHO Grading System. Both eyelids were everted and tarsal conjunctiva graded for signs of clinical trachoma. Ocular photographs of right eye were taken on random samples of sentinel children to determine the drift in grading over time. To detect CT infection, an ocular swab of the right eye using a Dacron swab was collected from the sentinel kids. The swab was stored dry, and frozen until shipped and processed in the laboratory. Air control swabs were also taken to test for field and laboratory contamination.
| community | ≥90% Coverage With Azithromycin Target | 80%-89% Coverage With Azithromycin Target | ≥90% Coveage With Azithromycin , Treatment Based | 80%-89% Coverage With Azithromycin : Treatment Based |
|---|---|---|---|---|
| Prevalence of trachoma in Tanzania at baseline | 30.7 ± 16.3 | 30.3 ± 13.5 | 31.1 ± 9.5 | 30.5 ± 10.4 |
| C.trachomatis infection in Tanzania at baseline | 24.6 ± 12.4 | 17.8 ± 10.3 | 23.0 ± 11.2 | 22.4 ± 23.3 |
| prevalence of trachoma in Gambia at baseline | 7.4 ± 26.1 | 5.6 ± 23.1 | 6.2 ± 24.1 | 6.1 ± 23.8 |
| C.trachomatis infection in Gambia at baseline | 0.9 ± 9.9 | 0.7 ± 8.6 | 1.2 ± 10.8 | 0.2 ± 2.9 |
| prevalence of trachoma in Niger at baseline | 28.4 ± 13.9 | 27.0 ± 17.3 | 23.9 ± 12.0 | 24.7 ± 13.0 |
| C.trachomatis infection in Niger at baseline | 21.9 ± 16.7 | 20.5 ± 16.8 | 15.6 ± 8.8 | 24.9 ± 14.1 |
100 random sentinel children aged 0- 5 years per community were to be examined for prevalence of trachoma \& CT infection in Tanzania \& Gambia. 50-100 random sentinel children aged 0-5 years per community were to be examined in Niger per community for prevalence of TF and CT infection. Outcomes are reported at the community level because raw data could not be accessed. There is no way to determine how many participants were examined in each arm.
| community | ≥90% Coverage With Azithromycin Target | 80%-89% Coverage With Azithromycin Target | ≥90% Coveage With Azithromycin, Treatment Based | 80%-89% Coverage With Azithromycin: Treatment Based |
|---|---|---|---|---|
| Prevalence of trachoma (TF) in Tanzania at 3 years | 9.0 ± 5.9 | 6.1 ± 4.0 | — | — |
| C.trachomatis infection in Tanzania at 3 years | 5.4 ± 3.7 | 4.0 ± 2.7 | — | — |
| Prevalence of trachoma (TF) in Gambia at 3 years | 3.0 ± 17.1 | 2.3 ± 14.9 | 3.2 ± 17.6 | 2.5 ± 15.7 |
| C.trachomatis infection in Gambia at 3 years | 0.2 ± 4.1 | 1.0 ± 9.5 | 0.7 ± 8.2 | 0.2 ± 4.2 |
| Prevalence of trachoma (TF) in Niger at 3 years | 8.9 ± 8.8 | 7.1 ± 7.8 | 5.4 ± 3.9 | 10.1 ± 10.5 |
| C.trachomatis infection in Niger at 3 years | 7.1 ± 6.8 | 4.6 ± 7.9 | 3.3 ± 3.6 | 4.4 ± 6.0 |
Collected over 3 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ≥90% Coverage With Azithromycin Target | — | 0/32 (0%) | 0/32 (0%) |
| 80%-89% Coverage With Azithromycin Target | — | 0/32 (0%) | 0/32 (0%) |
| ≥90% Coverage With Azithromycin , Treatment Based | — | 0/32 (0%) | 0/32 (0%) |
| 80%-89% Coverage With Azithromycin : Treatment Based | — | 0/32 (0%) | 0/32 (0%) |
For the final analysis the main effect of stop rule was not considered in Tanzania since no communities had prevalence \< 5%.Only the main effect of coverage was analyzed there. In Gambia and Niger stop rule was applied and analyzed along with the main effect of coverage.
| Age, Customized(community) | ≥90% Coverage With Azithromycin Target | 80%-89% Coverage With Azithromycin Target | ≥90% Coverage With Azithromycin , Treatment Based | 80%-89% Coverage With Azithromycin : Treatment Based | Total |
|---|---|---|---|---|---|
| Age not analyzed | NA | NA | NA | NA | NA |
| Sex/Gender, Customized(community) | ≥90% Coverage With Azithromycin Target | 80%-89% Coverage With Azithromycin Target | ≥90% Coverage With Azithromycin , Treatment Based | 80%-89% Coverage With Azithromycin : Treatment Based | Total |
|---|---|---|---|---|---|
| Sex/Gender not analyzed | NA | NA | NA | NA | NA |
| Region of Enrollment(community) | ≥90% Coverage With Azithromycin Target | 80%-89% Coverage With Azithromycin Target | ≥90% Coverage With Azithromycin , Treatment Based | 80%-89% Coverage With Azithromycin : Treatment Based | Total |
|---|---|---|---|---|---|
| Tanzania | 16 | 16 | 0 | 0 | 32 |
| Gambia | 12 | 12 | 12 | 12 | 48 |
| Niger | 12 | 12 | 12 | 12 | 48 |
Plan to share: No
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Studies of the drug tested here: Azithromycin