Partnership for Rapid Elimination of Trachoma (PRET)
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| ClinicalTrials.gov Identifier: NCT00792922 |
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Recruitment Status :
Completed
First Posted : November 18, 2008
Results First Posted : July 18, 2017
Last Update Posted : July 18, 2017
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Trachoma | Drug: Azithromycin | Phase 4 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 128 participants |
| Allocation: | Randomized |
| Intervention Model: | Factorial Assignment |
| Intervention Model Description: | The study was a factorial study model to begin with in all 3 countries (Niger,Tanzania and Gambia) but because we never stopped treatment in Tanzania and Niger site.Hence the study design was collapsed to a simple design in Tanzania and Niger.The study model was kept as a factorial design for the Gambia site. Protocol Enrollment refers to the number of communities, not the number of participants enrolled. |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Research to Programs for Trachoma Elimination: Antibiotic Trial |
| Study Start Date : | May 2008 |
| Actual Primary Completion Date : | June 2013 |
| Actual Study Completion Date : | June 2014 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: ≥90% coverage with azithromycin target
Selected communities will receive mass treatment annually for three years.
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Drug: Azithromycin
Comparison of community coverage rate
Other Name: Zithromax |
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Active Comparator: 80%-89% coverage with azithromycin target
Selected communities will receive mass treatment annually for three years.
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Drug: Azithromycin
Comparison of community coverage rate
Other Name: Zithromax |
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Active Comparator: ≥90% coverage with azithromycin , treatment based
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 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.
Other Name: Zithromax |
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Active Comparator: 80%-89% coverage with azithromycin : treatment based
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 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.
Other Name: Zithromax |
- Community Prevalence of Trachoma and Ocular C. Trachomatis (CT) Infection at Baseline [ Time Frame: 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.
- Community Prevalence of Trachoma and Ocular C. Trachomatis (CT) Infection at 36 Months [ Time Frame: 3 years ]
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.
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| Ages Eligible for Study: | up to 5 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Inclusion criteria for communities:
- Communities are located in the target districts and accessible by vehicle
- The community leaders consent to have the community enrolled
- Rapid assessment and/or available data suggest trachoma rates are higher than 20% in the community.
- The community size is <5,000 persons or >250 persons.
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:
- The child is age 5 years or younger
- The child must be a resident in an eligible, sample community (defined as either living in the community since birth, or moved in with parents or guardians).
- The child must not have an ocular condition that would preclude grading trachoma or taking an ocular specimen.
- The child must be willing to have a swab taken as part of being a sentinel child (this is critical for The Gambia and Tanzania, as each swab result counts towards meeting the stopping rule)
- The child must have an identifiable guardian capable of providing consent to participate.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00792922
| United States, California | |
| UCSF Proctor Foundation | |
| San Francisco, California, United States, 94143 | |
| United States, Maryland | |
| Johns Hopkins University | |
| Baltimore, Maryland, United States, 21205 | |
| United Kingdom | |
| London School of Hygiene and Tropical Medicine | |
| London, United Kingdom, WC1E 7HT | |
| Principal Investigator: | Sheila West, PhD | Johns Hopkins University |
| Responsible Party: | Johns Hopkins University |
| ClinicalTrials.gov Identifier: | NCT00792922 |
| Other Study ID Numbers: |
NA_00018439 |
| First Posted: | November 18, 2008 Key Record Dates |
| Results First Posted: | July 18, 2017 |
| Last Update Posted: | July 18, 2017 |
| Last Verified: | June 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
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Trachoma Azithromycin Mass treatment |
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Trachoma Conjunctivitis, Bacterial Eye Infections, Bacterial Bacterial Infections Chlamydia Infections Chlamydiaceae Infections Gram-Negative Bacterial Infections Eye Infections |
Infection Conjunctivitis Conjunctival Diseases Eye Diseases Corneal Diseases Azithromycin Anti-Bacterial Agents Anti-Infective Agents |