Effect of Intensive Fly Control on Trachoma and Ocular Chlamydia Infection in Tanzania
Primary Purpose
Trachoma
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
10% permethrin in water applied as low volume spray
Sponsored by
About this trial
This is an interventional prevention trial for Trachoma focused on measuring trachoma, chlamydia, flies, permethrin
Eligibility Criteria
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
Sites / Locations
- Johns Hopkins University/ Kongwa Trachoma Project
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
control
intervention
Arm Description
no active fly spray intervention
aerial spray of permethrin daily for two weeks and weekly as needed by assessment of fly density
Outcomes
Primary Outcome Measures
clinical trachoma
clinical grading of conjunctival photographs for follicular trachoma
Secondary Outcome Measures
ocular C. trachomatis infection
laboratory assessment of chlamydial DNA on ocular swab; measured as present or absent
Full Information
NCT ID
NCT00347763
First Posted
June 29, 2006
Last Updated
April 12, 2013
Sponsor
Johns Hopkins University
Collaborators
Wellcome Trust
1. Study Identification
Unique Protocol Identification Number
NCT00347763
Brief Title
Effect of Intensive Fly Control on Trachoma and Ocular Chlamydia Infection in Tanzania
Official Title
Strategies for the Control of Blinding Trachoma: Effect of Fly Spray
Study Type
Interventional
2. Study Status
Record Verification Date
May 2004
Overall Recruitment Status
Completed
Study Start Date
June 2000 (undefined)
Primary Completion Date
September 2002 (Actual)
Study Completion Date
October 2002 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Johns Hopkins University
Collaborators
Wellcome Trust
4. Oversight
5. Study Description
Brief Summary
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 chlamydia infection at 6 months and one year after mass antibiotic 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trachoma
Keywords
trachoma, chlamydia, flies, permethrin
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
350 (false)
8. Arms, Groups, and Interventions
Arm Title
control
Arm Type
No Intervention
Arm Description
no active fly spray intervention
Arm Title
intervention
Arm Type
Active Comparator
Arm Description
aerial spray of permethrin daily for two weeks and weekly as needed by assessment of fly density
Intervention Type
Procedure
Intervention Name(s)
10% permethrin in water applied as low volume spray
Primary Outcome Measure Information:
Title
clinical trachoma
Description
clinical grading of conjunctival photographs for follicular trachoma
Time Frame
1 year
Secondary Outcome Measure Information:
Title
ocular C. trachomatis infection
Description
laboratory assessment of chlamydial DNA on ocular swab; measured as present or absent
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sheila West
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University/ Kongwa Trachoma Project
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
16905024
Citation
West SK, Emerson PM, Mkocha H, McHiwa W, Munoz B, Bailey R, Mabey D. Intensive insecticide spraying for fly control after mass antibiotic treatment for trachoma in a hyperendemic setting: a randomised trial. Lancet. 2006 Aug 12;368(9535):596-600. doi: 10.1016/S0140-6736(06)69203-9.
Results Reference
result
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Effect of Intensive Fly Control on Trachoma and Ocular Chlamydia Infection in Tanzania
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