Malaria Elimination Pilot Study in Military Forces in Cambodia

Summary

Antimalarial drug resistance has reached critical levels on the Thai-Cambodian border. Many have begun advocating for concerted malaria elimination efforts in Cambodia. However, there is currently no consensus on how malaria elimination is to be achieved with the tools available.

In this study, the investigators will conduct operational research with the Royal Cambodian Armed Forces (RCAF) and National Malaria Center (CNM) to quantify the relative effectiveness of the two major interventional approaches - monthly malaria prophylaxis (MMP) or focused screening and treatment (FSAT) - in a head to-head comparison. In addition, the investigators will quantify the relative contribution of a recently advocated vector intervention for military personnel - the insecticide treated uniform (ITU) - in addition to other vector control measures currently employed by the RCAF. The investigators will employ the same permethrin insecticide self-application kits currently used by the US military. The investigators will estimate the cost effectiveness of each approach and attempt to define the best way forward for malaria elimination efforts in a critically important malaria reservoir in military population (and their dependents) who reside on the Thai-Cambodian border. The aim of the study is not only to conduct research to better define the best way forward in malaria elimination efforts in the high risk military populations, but to also build capacity within the RCAF to support and lead future elimination efforts in the most difficult-to-reach mobile populations.

Conditions

• Malaria
• Parasitic Diseases

Interventions

DRUG

DHA-PIP

Administered monthly (weight-based) on days 1-3, during months 1, 2, and 3 in the MMP arm and also as a first line agent for P.v malaria recurrence in both MMP and FSAT treatment arms

DRUG

Primaquine

22.5 mg weekly for 12 weeks in the MMP arm; low dose primaquine (15mg) for transmission blocking of P. falciparum or 14 days of primaquine (15mg) in G6PD normal volunteers or 8 weeks of low dose primaquine (45mg) in G6PD-deficient volunteers for radical cure of P. vivax

DRUG

Artesunate + Mefloquine

Weight based; first line agent for P.f malaria infection diagnosed at monthly follow ups, administered on days 1-3 in subjects with malaria recurrence

DRUG

Permethrin (Insecticide treated uniform)

40% Permethrin IDA kit, applied once to the uniforms for volunteers assigned to ITU arm

Sponsors & Collaborators

• National Center for Parasitology, Entomology, and Malaria Control (CNM)

  collaborator UNKNOWN

• Ministry of National Defense, Royal Cambodian Armed Forces Department of Health

  collaborator UNKNOWN

• Armed Forces Research Institute of Medical Sciences, Thailand

  lead OTHER_GOV

Principal Investigators

• Chanthap Lon, MD · Armed Forces Research Institute of Medical Sciences, Thailand

• Mariusz Wojnarski, MD · Armed Forces Research Institute of Medical Sciences, Thailand

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

2 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2016-01-31

Primary Completion

2016-08-31

Completion

2021-12-31

Countries

• Cambodia

Study Locations