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CompletedNCT00347763Updated Apr 15, 2013

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

A Phase 4 interventional study of 10% permethrin in water applied as low volume spray in Trachoma, sponsored by Johns Hopkins University. Completed at 1 site in United States. Open to participants aged 12 Months to 8 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-04-15.

Sponsored by Johns Hopkins University · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
350
Allocation
Randomized
Ages
12 Months to 8 Years
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Trachoma

Keywords

  • trachoma
  • chlamydia
  • flies
  • permethrin
03

In context

Trachoma

39 studies on the registry are indexed under Trachoma; 3 are open to participants now.

This study's enrollment of 350 is below the median of 1,300 across 31 interventional studies indexed under Trachoma.

Browse Trachoma studies →

Lead sponsor

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.

04

Who can participate

Ages eligible
12 Months to 8 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Balozi in Chiwe area
  • Sentinel children: age less than 8 years

Exclusion criteria

Exclusion Criteria:

  • Balozi in Chiwe without geographic borders
  • Sentinel children:age more than 8 years
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
350 participants

Study arms

  • 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

Interventions

  • Procedure10% permethrin in water applied as low volume spray
06

What researchers measure

Primary outcomes

  1. clinical trachoma

    clinical grading of conjunctival photographs for follicular trachoma

    Time frame: 1 year

Secondary outcomes

  1. ocular C. trachomatis infection

    laboratory assessment of chlamydial DNA on ocular swab; measured as present or absent

    Time frame: 6 months

07

Study locations

1 site
  • Johns Hopkins University/ Kongwa Trachoma Project
    Baltimore, Maryland 21205, United States
08

References and documents

Publications

  • 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. PubMed 16905024 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2000, a primary completion of Sep 2002 and a completion of Oct 2002. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 29, 2006
First posted
Jul 4, 2006
Start
Jun 2000
Primary completionActual
Sep 2002
CompletionActual
Oct 2002
Last update
Apr 15, 2013
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 15, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00347763
Collaborators
Wellcome Trust
First posted
Jul 4, 2006
Start date
Jun 2000
Primary completion
Sep 2002
Completion
Oct 2002
Last update
Apr 15, 2013

Study contacts

Sheila West
principal investigator · Johns Hopkins University
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2004. You cannot join it, but the record below documents what was studied.

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