NCT00347763

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2000

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2000

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2002

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2002

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

June 29, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 4, 2006

Completed
Last Updated

April 15, 2013

Status Verified

May 1, 2004

Enrollment Period

2.3 years

First QC Date

June 29, 2006

Last Update Submit

April 12, 2013

Conditions

Trachoma

Keywords

trachomachlamydiafliespermethrin

Outcome Measures

Primary Outcomes (1)

  • clinical trachoma

    clinical grading of conjunctival photographs for follicular trachoma

    1 year

Secondary Outcomes (1)

  • ocular C. trachomatis infection

    6 months

Study Arms (2)

control

NO INTERVENTION

no active fly spray intervention

intervention

ACTIVE COMPARATOR

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

10% permethrin in water applied as low volume sprayPROCEDURE
intervention

Eligibility Criteria

Age12 Months - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins University/ Kongwa Trachoma Project

Baltimore, Maryland, 21205, United States

Location

Related Publications (1)

  • 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.

    PMID: 16905024RESULT

MeSH Terms

Conditions

TrachomaChlamydia Infections

Interventions

Permethrin

Condition Hierarchy (Ancestors)

Conjunctivitis, BacterialEye Infections, BacterialBacterial InfectionsBacterial Infections and MycosesInfectionsChlamydiaceae InfectionsGram-Negative Bacterial InfectionsEye InfectionsConjunctivitisConjunctival DiseasesEye DiseasesCorneal DiseasesSexually Transmitted Diseases, BacterialSexually Transmitted DiseasesCommunicable DiseasesGenital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Phenyl EthersEthersOrganic ChemicalsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPyrethrinsCyclopentane MonoterpenesMonoterpenesTerpenes

Study Officials

  • Sheila West

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 29, 2006

First Posted

July 4, 2006

Study Start

June 1, 2000

Primary Completion

September 1, 2002

Study Completion

October 1, 2002

Last Updated

April 15, 2013

Record last verified: 2004-05

Locations

US(1)