NCT02938975: URCT

Field Efficacy Of Insecticide Treated Uniforms And Skin Repellents To Reduce Malaria Incidence In Military Personnel On Active Duty In Regions Of Hyperendemicity

Status unknown Phase 3 Last updated 3 June 2017

What this trial tests

Phase 3 trial testing Ultra 30 Insect Repellent Lotion (30% Lipo DEET) in Malaria in 1,500 participants. Status unknown.

Timeline

1 November 2017

Primary endpoint
1 January 2019

1 June 2019

Quick facts

Lead sponsor	Ifakara Health Institute
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	1,500
Start date	1 November 2017
Primary completion	1 January 2019
Estimated completion	1 June 2019
Sites	1 location across Tanzania

Drugs / interventions tested

• Ultra 30 Insect Repellent Lotion (30% Lipo DEET)
• Permethrin Factory-Treated Army Combat Uniforms
• Placebo lotion — full drug profile →
• Army combat uniform

Conditions studied

• Malaria — all drugs for Malaria →

Sponsor

Ifakara Health Institute

Who can join

Adults 18 to 40, any sex, with Malaria. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Incidence of Plasmodium falciparum malaria through monthly measurement of malaria positivity by direct polymerase chain reaction (PCR) to detect parasite DNA
  Time frame: Monthly active case detection for 12 months
  Blood spots will be collected on Whatman 3 filter paper and processed for PCR detection of parasites

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Mosquito repellents for malaria prevention.
   Maia MF, Kliner M, Richardson M, Lengeler C, et al · · 2018 · cited 67× · PMID 29405263 · DOI 10.1002/14651858.cd011595.pub2
2. Topical repellents for malaria prevention.
   Gabaldón Figueira JC, Wagah MG, Adipo LB, Wanjiku C, et al · · 2023 · cited 11× · PMID 37602418 · DOI 10.1002/14651858.cd015422.pub2
3. 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.
   Msellemu D, Ross A, Temu L, Moshi I, et al · · 2021 · cited 7× · PMID 34802455 · DOI 10.1186/s13063-021-05801-9
4. Multi-omics insights into mosquito insecticide resistance for integrated vector management.
   Li J, Wang QY. · · 2026 · PMID 42038460 · DOI 10.7717/peerj.21083
5. 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
   Msellemu D, Ross A, Temu L, Moshi I, et al · · 2021 · DOI 10.21203/rs.3.rs-618550/v1