Field Efficacy Of Insecticide Treated Uniforms And Skin Repellents for Malaria Prevention

Summary

Purpose

While there is strong evidence that permethrin treated clothing prevents insect bites there is insufficient evidence from trials to demonstrate a reduction in infections. The evidence that topical insect repellants prevent malaria is more robust, but studies in civilian suffer from poor compliance. It is not known if there is an added benefit from combining the two. The effectiveness of permethrin-treated uniforms with and without DEET lotion are compared in a 2x2 design in Mgambo Jeshi la Kujenga Taifa (JKT) military camp in Tanga region.

The four arms are: 1) combined intervention group receiving permethrin treated uniform (PTU) and 30% DEET (diethyl toluamide) liposome formula; 2) permethrin intervention group receiving PTU and placebo lotion; 3) DEET intervention group receiving untreated army combat uniform (ACU) and 30% DEET liposome formula; 4) placebo group receiving untreated ACU and placebo lotion. Both participants and investigators will be blinded to treatment allocation.

The outcome measure is the incidence of Plasmodium falciparum malaria infection measured by Polymerase Chain Reaction every month by active case detection.

Conditions

• Malaria

Interventions

OTHER

Ultra 30 Insect Repellent Lotion (30% Lipo DEET)

One application of Lipo DEET protects for up to 12 hours and has a pleasant odour and non-greasy "feel" on the skin. DEET is a broad spectrum insect repellent and was selected this study because it has been extensively tested for safety and toxicity for human use and its efficacy against a broad variety of arthropod vectors. DEET was first registered in 1957 and has been conclusively proven to be safe for use on adults, children, pregnant and lactating mothers. This Liposome-based repellent is the newest advancement in insect repellent technology. The Liposome envelops the active ingredient, DEET, and slowly time-releases it as needed, thereby extending the effectiveness of the repellent and reducing dermal absorption.

OTHER

Permethrin Factory-Treated Army Combat Uniforms

Permethrin is the U.S., Australian and United Kingdom (UK) military's standard repellent for application to fabric and is considered the most effective clothing treatment available to prevent insect bites through fabric. The Army objective is to provide 90% bite protection for at least 50 launderings; an objective easily met through factory treatment of uniforms, which demonstrates 99-100% bite protection up to 50 launderings (the expected lifetime of the uniform).

OTHER

Placebo lotion

A liposome lotion with no DEET

OTHER

Army combat uniform

Army combat uniform with no permethrin

Sponsors & Collaborators

• Swiss Tropical & Public Health Institute

  collaborator OTHER

• Walter Reed Army Institute of Research (WRAIR)

  collaborator FED

• U.S. Army Medical Research and Development Command

  collaborator FED

• Ifakara Health Institute

  lead OTHER

Principal Investigators

• Sarah J Moore, PhD · Ifakara Health Institute

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

40 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-11-30

Primary Completion

2019-01-31

Completion

2019-06-30

FDA Drug

Yes

Countries

• Tanzania

Study Locations