Status:
SUSPENDED
Antimalarial Drug Resistance With Assessment of Transmission Blocking Activity
Lead Sponsor:
David Saunders
Collaborating Sponsors:
National Centre for Parasitology, Entomology and Malaria Control, Cambodia
Royal Cambodian Armed Forces
Conditions:
Uncomplicated Plasmodium Falciparum Malaria
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
This is a two-arm, open label Treatment Study comparing the efficacy, safety, tolerability and pharmacokinetics of a three-day course of Dihydroartemisinin-Piperaquine (DP) with or without single-dose...
Detailed Description
Volunteers with uncomplicated malaria in Cambodia will be enrolled to current standard of care therapy with DHA-piperaquine to monitor therapeutic efficacy and measure resistance. The cardiac safety o...
Eligibility Criteria
Inclusion
- Volunteer 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 1,000-200,000 parasites/uL
- Able to provide informed consent
- Available and agree to follow-up for anticipated study duration including 3 day treatment course at the MTF and weekly follow-up for the 42-day period
- Authorized by local commander to participate if active duty military
Exclusion
- Allergic reaction or contraindication to DHA, piperaquine or primaquine
- Significant acute comorbidity requiring urgent medical intervention
- Signs/symptoms and parasitological confirmation of severe malaria
- Use of any anti-malarial within the past 14 days.
- Class I or II G6PD deficiency (defined as severe) as determined at screening
- 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
- Clinically significant abnormal EKG, including a QTcF interval \> 500 ms at enrollment.
- Known or suspected concomitant use of QTc prolonging medications.
- Judged by the investigator to be otherwise unsuitable for study participation
Key Trial Info
Start Date :
December 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2016
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT01849640
Start Date
December 1 2012
End Date
June 1 2016
Last Update
July 15 2015
Active Locations (1)
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1
Anlong Veng Referral Hospital
Anlong Veaeng, Oddormean Chey, Cambodia