Overview

Antimalarial Drug Resistance With Assessment of Transmission Blocking Activity

Status:
Suspended
Trial end date:
2016-06-01
Target enrollment:
0
Participant gender:
All
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 primaquine in patients with uncomplicated Plasmodium falciparum malaria. On the last day of DP therapy, volunteers will be randomized to receive either a single 45 mg dose of primaquine (PQ) or DP treatment only (no primaquine).
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
David Saunders
Collaborators:
National Centre for Parasitology, Entomology and Malaria Control, Cambodia
Royal Cambodian Armed Forces
US Department of Defense Armed Forces Health Surveillance Center
Treatments:
Piperaquine
Primaquine
Criteria
Inclusion Criteria:

1. Volunteer with uncomplicated P. falciparum malaria (volunteers with mixed P.
falciparum and P. vivax infections may be enrolled), 18-65 years of age

2. Baseline asexual parasite density between 1,000-200,000 parasites/uL

3. Able to provide informed consent

4. 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

5. Authorized by local commander to participate if active duty military

Exclusion Criteria:

1. Allergic reaction or contraindication to DHA, piperaquine or primaquine

2. Significant acute comorbidity requiring urgent medical intervention

3. Signs/symptoms and parasitological confirmation of severe malaria

4. Use of any anti-malarial within the past 14 days.

5. Class I or II G6PD deficiency (defined as severe) as determined at screening

6. 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

7. Clinically significant abnormal EKG, including a QTcF interval > 500 ms at enrollment.

8. Known or suspected concomitant use of QTc prolonging medications.

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