Malaria Elimination Pilot Study in Military Forces in Cambodia

• Register: ClinicalTrials.gov
• Last refreshed on: 16 March 2021
• Main ID: NCT02653898
• Date of registration: 08/01/2016
• Prospective Registration: No
• Primary sponsor: Armed Forces Research Institute of Medical Sciences, Thailand
• Public title: Malaria Elimination Pilot Study in Military Forces in Cambodia
• Scientific title: Defining Effective, Appropriate, Implementable Strategies for Malaria Elimination in Military Forces in Cambodia as a Model for Mobile Populations
• Date of first enrolment: January 2016
• Target sample size: 1050
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT02653898
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Cambodia

Contacts

• Name: Chanthap Lon, MD
• Affiliation: Armed Forces Research Institute of Medical Sciences, Thailand

• Name: Mariusz Wojnarski, MD
• Affiliation: Armed Forces Research Institute of Medical Sciences, Thailand

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Military volunteers aged 18-65 years of age plus their dependents > 2 years of age,
eligible for care at an RCAF facility, or otherwise eligible Cambodian civilians at
risk for contracting malaria who live within the designated geographical areas

2. Able to give informed consent/assent

3. Resides in the selected study areas, and available for monthly follow-up for 6 month
study duration

4. Agrees not to seek outside medical care for febrile illness unless referred by study
team

5. Authorized by local commander to participate in the study if on active duty

Exclusion Criteria:

1. Allergic reaction or contraindication to dihydroartemisinin-piperaquine or primaquine
or artesunate+mefloquine

2. Pregnant or lactating female, or female of childbearing age, up to 50 years of age or
otherwise individually assessed for childbearing potential, who does not agree to use
an acceptable form of contraception during the study

3. Judged by the investigator to be otherwise unsuitable for study participation



Age minimum: 2 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Malaria

Parasitic Diseases

Intervention(s)

Drug: DHA-PIP

Drug: Permethrin (Insecticide treated uniform)

Drug: Primaquine

Drug: Artesunate + Mefloquine

Primary Outcome(s)

The absolute risk reduction based on the proportion of subjects remaining malaria-free at the end of 6 months between the study arms as diagnosed by PCR-corrected malaria microscopy [Time Frame: 6 months]

Secondary Outcome(s)

Percent reduction in hemoglobin and HTC for each 2D6 haplotype in subjects with available CBC following PQ dosing [Time Frame: Day 3 (and day 7 in those volunteers with Hgb or HCT drop of at least 10% from baseline on Day 3)]

Estimate of apparent rates of preexisting immunity to malaria based on medical history, days of fever prior to presentation, and preexisting parasitological parameters (gametocytemia, low asexual stage parasitemias) [Time Frame: 6 months]

Comparative incidence of G6PD deficiency in the study population as determined by RDT, quantitative, and qualitative tests [Time Frame: At the time of enrollment]

Odds ratio for P.v recurrence for each CYP2D6 phenotype [Time Frame: 6 months]

Overall rate of sexual stage infections at Months 1 through 6 in each arm based on a combined endpoint of light microscopy and PCR analysis for detection of gametocyte maturity. [Time Frame: 6 months]

Sensitivity and specificity assessment of the currently recommended rapid diagnostic test in Cambodia to detect moderate to severe G6PD deficiency using quantitative G6PD testing as the reference standard [Time Frame: At the time of enrollment]

Comparative incidence of malaria detected by RDT versus RT-PCR versus microscopy [Time Frame: 6 months]

Kaplan-Meier survival analysis of asexual and sexual blood stage at 28-day intervals after treatment or prophylaxis up to 180 days [Time Frame: 6 months]

Comparison of all-species and species-specific malaria incidence density in each arm over 180-day period [Time Frame: 6 months]

Number of participants with abnormal lab values and/or Adverse Events that are related to the treatments in each arm [Time Frame: 6 months]

Rate of cytochrome P450 2D6 genotypes/phenotypes in the population at risk [Time Frame: 6 months]

Percentage of subjects with malaria recurrence for each CYP2D6 phenotype [Time Frame: 6 months]

Secondary ID(s)

WR2211

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

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

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