Status:
UNKNOWN
The ASAP Study - Therapeutic Efficacy of Atovaquone-proguanil vs. Artesunate-atovaquone-proguanil in Cambodia
Lead Sponsor:
Armed Forces Research Institute of Medical Sciences, Thailand
Collaborating Sponsors:
National Centre for Parasitology, Entomology and Malaria Control, Cambodia
Naval Medical Research Center, Asia (NMRC-A)
Conditions:
Malaria
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
This is a two-arm, randomized, open label Treatment Study evaluating the therapeutic efficacy, safety, tolerability and pharmacokinetics of a three-day course of Atovaquone-Proguanil (AP) or a three-d...
Eligibility Criteria
Inclusion
- Male or female with uncomplicated P. falciparum malaria (volunteers with mixed P. falciparum and P. vivax infections may be enrolled), 18-65 years of age
- Baseline asexual parasite density between 100-200,000 parasites/microL
- Able to provide informed consent
- Available and agree to follow-up for anticipated study duration including 3 day treatment course at the Medical Treatment Facility, and weekly follow-up for the 42-day period.
Exclusion
- Allergic reaction or medical contraindication to atovaquone, proguanil, artesunate or primaquine, to include a calculated serum creatinine clearance estimate of less than 30mL/min
- Significant acute comorbidity requiring urgent medical intervention
- Signs/symptoms and parasitological confirmation of severe malaria
- Use of any anti-malarial within the past 7 days, or atovaquone-proguanil in the past 30 days
- Use of the following concomitant medications within 7 days, which may cause or be volunteers to significant drug-drug interactions with study drug - tetracycline, metoclopramide, rifampin, rifabutin, zidovudine or etoposide.
- Pregnant or lactating female, or female of childbearing age, up to 50 years of age, who does not agree to use an acceptable form of contraception during the study
- Judged by the investigator to be otherwise unsuitable for study participation
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2021
Estimated Enrollment :
205 Patients enrolled
Trial Details
Trial ID
NCT02297477
Start Date
December 1 2014
End Date
December 1 2021
Last Update
March 2 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Anlong Veng Referral Hospital
Anlong Veaeng, Oddar Meancheay, Cambodia