Effect of Intensive Fly Control on Trachoma and Ocular Chlamydia Infection in Tanzania

This study has been completed.
Sponsor:
Collaborator:
Wellcome Trust
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00347763
First received: June 29, 2006
Last updated: April 12, 2013
Last verified: May 2004
  Purpose

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.


Condition Intervention Phase
Trachoma
Procedure: 10% permethrin in water applied as low volume spray
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Strategies for the Control of Blinding Trachoma: Effect of Fly Spray

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • clinical trachoma [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    clinical grading of conjunctival photographs for follicular trachoma


Secondary Outcome Measures:
  • ocular C. trachomatis infection [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    laboratory assessment of chlamydial DNA on ocular swab; measured as present or absent


Estimated Enrollment: 350
Study Start Date: June 2000
Study Completion Date: October 2002
Primary Completion Date: September 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Procedure: 10% permethrin in water applied as low volume spray

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

  Eligibility

Ages Eligible for Study:   12 Months to 8 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00347763

Locations
United States, Maryland
Johns Hopkins University/ Kongwa Trachoma Project
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins University
Wellcome Trust
Investigators
Principal Investigator: Sheila West Johns Hopkins University
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00347763     History of Changes
Other Study ID Numbers: WellcomeTrust 059134
Study First Received: June 29, 2006
Last Updated: April 12, 2013
Health Authority: United States: Institutional Review Board
Tanzania: National Institute for Medical Research

Keywords provided by Johns Hopkins University:
trachoma
chlamydia
flies
permethrin

Additional relevant MeSH terms:
Trachoma
Bacterial Infections
Chlamydia Infections
Chlamydiaceae Infections
Conjunctival Diseases
Conjunctivitis
Conjunctivitis, Bacterial
Corneal Diseases
Eye Diseases
Eye Infections
Eye Infections, Bacterial
Gram-Negative Bacterial Infections
Infection
Permethrin
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 22, 2014