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

NCT02938975 | Unknown Phase 3 DMC FDA Drug

• 1 other identifier: BIT014 PR001 V01
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

malaria; personal protection; permethrin treated clothing; insect repellents; army personnel; cluster randomised trial

Outcome Measures

Primary Outcomes (1)

• Incidence of Plasmodium falciparum malaria through monthly measurement of malaria positivity by direct polymerase chain reaction (PCR) to detect parasite DNA

  Blood spots will be collected on Whatman 3 filter paper and processed for PCR detection of parasites

  Monthly active case detection for 12 months

Secondary Outcomes (3)

• Incidence of clinical malaria through monthly measurement malaria positivity of SD Bioline Malaria Rapid Diagnostic Test to test for parasite antigen

  Active and passive case detection for 12 months

• Compliance with intervention as measured through spot checking and weighing of repellent bottles

  Monthly assessment of intervention compliance with uniforms and lotions provided for 12 months

• Protective efficacy of uniforms measured by reduction in Anopheles arabiensis bites among those wearing uniforms for a sub-sample of uniforms tested under laboratory conditions with free flying mosquitoes

  After 12 months

Study Arms (4)

Placebo

PLACEBO COMPARATOR

placebo group receiving untreated army combat uniform and placebo lotion. Assigned interventions: Placebo lotion - a liposome lotion with no DEET Army combat uniform - army combat uniform with no permethrin

Other: Placebo lotion; Other: Army combat uniform

Combo

ACTIVE COMPARATOR

Combined intervention group of receiving Permethrin treated uniform 0.52% w/w and 30% DEET liposome formula. Ultra 30 Insect Repellent Lotion (30% Lipo DEET) One application of Lipo DEET protects for up to 12 hours. DEET is a broad spectrum insect repellent that has been extensively tested for safety and toxicity for human use and its efficacy against a broad variety of arthropod vectors. Permethrin Factory-Treated Army Combat Uniforms treated by the military apparel contractor Warmkraft Permethrin 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.

Other: Ultra 30 Insect Repellent Lotion (30% Lipo DEET); Other: Permethrin Factory-Treated Army Combat Uniforms

Permethrin

ACTIVE COMPARATOR

permethrin intervention group receiving Permethrin treated uniform 0.52% w/w and placebo lotion. Permethrin Factory-Treated Army Combat Uniforms treated by the military apparel contractor Warmkraft Placebo lotion: liposome lotion with no DEET

Other: Permethrin Factory-Treated Army Combat Uniforms; Other: Placebo lotion

DEET

ACTIVE COMPARATOR

DEET intervention group receiving untreated army combat uniform and 30% DEET liposome formula. Ultra 30 Insect Repellent Lotion (30% Lipo DEET) Army combat uniform with no permethrin

Other: Ultra 30 Insect Repellent Lotion (30% Lipo DEET); Other: Army combat uniform

Interventions

Ultra 30 Insect Repellent Lotion (30% Lipo DEET) OTHER

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.

Combo; DEET

Permethrin Factory-Treated Army Combat Uniforms OTHER

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).

Combo; Permethrin

Placebo lotion OTHER

A liposome lotion with no DEET

Permethrin; Placebo

Army combat uniform OTHER

Army combat uniform with no permethrin

DEET; Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Member of a platoon passes physical examination - no underlying health risks females that are not pregnant malaria negative at enrolment consents to participate

You may not qualify if:

• Not assigned to a platoon underlying health risks - does not pass physical examination pregnant female (pregnant females are not recruited into the army) malaria positive at enrolment does not consent to participate

Sponsors & Collaborators

• Ifakara Health Institute: lead
• Swiss Tropical & Public Health Institute: collaborator
• Walter Reed Army Institute of Research (WRAIR): collaborator
• U.S. Army Medical Research and Development Command: collaborator

Study Sites (1)

Ifakara Health Institute

Bagamoyo, 74, Tanzania

Location

Related Publications (1)

• Msellemu D, Ross A, Temu L, Moshi I, Hofer L, Mwanziva C, Kohi YM, Moore SJ. Effect of interventions to reduce malaria incidence among military personnel on active duty: study protocol for a cluster randomised controlled trial of the impact of etofenprox-treated uniforms, permethrin-treated uniforms and DEET insect repellent. Trials. 2021 Nov 21;22(1):825. doi: 10.1186/s13063-021-05801-9.

  PMID: 34802455 DERIVED

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Officials

• Sarah J Moore, PhD

  Ifakara Health Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah J Moore, PhD

CONTACT

+255764802622; smoore@ihi.or.tz

Daniel F Msellemu, MSc

CONTACT

dmsellemu@ihi.or.tz

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Placebo
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2016
• First Posted: October 19, 2016
• Study Start: November 1, 2017
• Primary Completion: January 1, 2019
• Study Completion: June 1, 2019
• Last Updated: June 6, 2017

Record last verified: 2017-06

Locations

TA (1)