NCT00144716

Brief Summary

Insecticide Treated Nets (ITN's) offer good protection against malaria in Africa where the vector mosquitoes feed indoors late at night. However, in other parts of the world like South America, vectors feed earlier in the evening before people go to bed. In such cases it may be necessary to use alternative treatments in the evening to supplement the efficacy of ITN's. This study compares 2 matched groups of households in the Bolivian Amazon. One group will be given ITN's plus a plant-based insect repellent in the evening, the other has ITN's plus a placebo lotion. Households are monitored over a full malaria season to record numbers of malaria cases.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
4,250

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jun 2003

Shorter than P25 for phase_3

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2003

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

September 2, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 5, 2005

Completed
Last Updated

January 12, 2017

Status Verified

January 1, 2017

First QC Date

September 2, 2005

Last Update Submit

January 11, 2017

Conditions

Malaria

Keywords

Vector ControlrepellentITN'smalariaAmazon

Outcome Measures

Primary Outcomes (1)

  • Reduction in cases of malaria

Secondary Outcomes (1)

  • Reduction in all-cause fevers

Interventions

Insect Repellent plus Insecticide Treated NetDEVICE

Eligibility Criteria

Age10 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Written informed consent.
  • Available for 4 x monthly follow ups.
  • or more individuals in household.

You may not qualify if:

  • Allergy to repellents / plants.
  • Malaria positive at baseline.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Hill N, Lenglet A, Arnez AM, Carneiro I. Plant based insect repellent and insecticide treated bed nets to protect against malaria in areas of early evening biting vectors: double blind randomised placebo controlled clinical trial in the Bolivian Amazon. BMJ. 2007 Nov 17;335(7628):1023. doi: 10.1136/bmj.39356.574641.55. Epub 2007 Oct 16.

    PMID: 17940319DERIVED

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Study Officials

  • Nigel Hill, PhD

    London School of Hygiene and Tropical Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 2, 2005

First Posted

September 5, 2005

Study Start

June 1, 2003

Study Completion

October 1, 2003

Last Updated

January 12, 2017

Record last verified: 2017-01