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Drug Combinations of Atovaquone-Proguanil (AP) With ACT

NCT03726593 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 252

Last updated 2021-03-02

No results posted yet for this study

Summary

Investigators are conducting this study due to recent reports of many of existing malaria drugs becoming less effective for treatment of malaria. The drugs may not always kill all the parasites, therefore not all patients with malaria are being cured. The main objective of the study is to find out which malaria drugs and what drug combinations are still effective in Cambodia, an area of multi-drug resistance where 4-5 artemisinin-based combination therapies have shown inadequate response, below that established by the World Health Organization (WHO). New drug combinations (taking more than one drug for malaria at the same time), as long as well tolerated, can provide cure in patients that harbor parasites not responsive to standard first-line medications. Human genetic testing will be done to identify patients who may have suboptimal response to treatments and to study the differences in human gene expression to explain why some persons are at higher risk of complications during treatment. Markers of drug resistance to commonly used antimalarial drugs will also be evaluated and shared with national malaria program (CNM) to better guide future malaria treatment decisions in Cambodia.

Conditions

  • Plasmodium Falciparum Malaria (Drug Resistant)

Interventions

DRUG

Artesunate and Pyronaridine

Standard weight based dosing

DRUG

Atovaquone Proguanil and Artesunate Pyronaridine

Both drugs (AP) and (ASPY) are administered once a day, on days 0, 1, and 2.

DRUG

Atovaquone Proguanil and Artesunate Mefloquine

Sequential treatment with ASMQ (on days 0, 1, and 2) followed by the treatment with AP for 3 more days (total 6 days treatment)

Sponsors & Collaborators

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

    collaborator UNKNOWN

  • Naval Medical Research Unit-2 (NAMRU-2)

    collaborator UNKNOWN

  • Armed Forces Research Institute of Medical Sciences, Thailand

    lead OTHER_GOV

Principal Investigators

  • Mariusz Wojnarski, MD · Armed Forces Research Institute of Medical Sciences (AFRIMS) Bangkok, Thailand

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-04
Primary Completion
2022-08-30
Completion
2022-12-30

Countries

  • Cambodia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03726593 on ClinicalTrials.gov