- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00347763
Effect of Intensive Fly Control on Trachoma and Ocular Chlamydia Infection in Tanzania
Strategies for the Control of Blinding Trachoma: Effect of Fly Spray
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Trachoma is the leading infectious cause of blindness in the world. The World Health Organization (WHO), recognizing the important public health impact of trachoma, has adopted a resolution to eliminate blinding trachoma by the year 2020 (3). In order to accomplish this ambitious goal, WHO recommends the use of "SAFE" strategy for countries implementing trachoma control programs. This multi-faceted approach includes Surgery for trichiasis cases, Antibiotics to treat the community pool of infection, Face washing to reduce transmission, and Environmental change.
The environmental change component currently rests largely on efforts to reduce the fly populations in these communities. A pilot study and clinical trial using intense insecticide spraying reduced both flies and trachoma in a trachoma hypo-endemic area of The Gambia. In The Gambia setting, flies appear to be an important vector for trachoma, but it is not clear that flies are equally important in areas with hyper-endemic trachoma, nor is it known if fly control adds value to the provision of mass antibiotic treatment for active trachoma as part of the SAFE strategy.
The purpose of this community-based randomized trial was to determine, in trachoma hyper-endemic communities of Tanzania, the added value of intensive spraying to control flies on the fly population and on trachoma and ocular C. trachomatis infection at 6 months and one year after mass antibiotic treatment. Neighborhoods with intensive spraying (Intervention) and neighborhoods with no spraying (control) all received mass antibiotic treatment with azithromycin immediately prior to the start of the study, enabling us to evaluate the additional impact of fly control on trachoma.
Kongwa district in central Tanzania has been shown to have a high prevalence of active trachoma, and was chosen as the site of this study. We randomized sixteen balozi to receive either mass treatment with azithromycin alone (control), or mass treatment plus an intensive fly spraying program (intervention). Pre-school aged children are the reservoirs of infection and disease within these communities. Therefore, within each balozi, all children aged less than eight served as sentinel markers for the status of trachoma at baseline, 6 months, and one year after baseline. In the eight intervention balozi, 119 children from 87 families were enrolled at baseline, and in the eight control balozi, 183 children from 145 families were enrolled.
The balozis were surveyed and an area surrounding the intervention balozis was targeted for insecticide spray. A solution of 10% permethrin in water was used with a Hudson and MicronAir sprayer machines, At the outset, spraying was carried out every two days for two weeks (attack phase) then once per week (maintenance phase) for the rest of the study.
Two sticky traps, fly paper strips were placed in each balozi to capture flies. The traps were changed every week, and the number of flies captured were counted. If the average number in the intervention balozis exceeded 25% of that in the control balozis, an attack phase, as described above, was reinstituted to keep the fly population low in the intervention group.
The primary outcome was the prevalence of trachoma in the pre-school aged children at 6 months and one year post mass antibiotic treatment.Outcomes are reported based on masked photographic gradings. Secondary outcome was ocular C. trachomatis infection, based on use of Amplicor C. trachomatis qualitative PCR assay.
comparison: Balozi randomized to receive intensive fly spray intervention,compared to Balozi with no fly spray intervention
Study Type
Enrollment
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21205
- Johns Hopkins University/ Kongwa Trachoma Project
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Balozi in Chiwe area
- Sentinel children: age less than 8 years
Exclusion Criteria:
- Balozi in Chiwe without geographic borders
- Sentinel children:age more than 8 years
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: control
no active fly spray intervention
|
|
Active Comparator: intervention
aerial spray of permethrin daily for two weeks and weekly as needed by assessment of fly density
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
clinical trachoma
Time Frame: 1 year
|
clinical grading of conjunctival photographs for follicular trachoma
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ocular C. trachomatis infection
Time Frame: 6 months
|
laboratory assessment of chlamydial DNA on ocular swab; measured as present or absent
|
6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Sheila West, Johns Hopkins University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Infections
- Eye Diseases
- Gram-Negative Bacterial Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Conjunctivitis
- Conjunctival Diseases
- Corneal Diseases
- Chlamydiaceae Infections
- Eye Infections, Bacterial
- Eye Infections
- Chlamydia Infections
- Conjunctivitis, Bacterial
- Trachoma
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Permethrin
Other Study ID Numbers
- WellcomeTrust 059134
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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