Trial | NCT01849640  Report issue

Title

Antimalarial Drug Resistance With Assessment of Transmission Blocking Activity
Active Surveillance for P. Falciparum Drug Resistance With Assessment of Transmission Blocking Activity of Single Dose Primaquine in Cambodia

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Suspended

  • Study Participants

    150
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).
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 of piperaquine will be monitored with electrocardiograms during the treatment period. Resistance to DP and DP-PQ will be assessed by a combination of clinical, pharmacologic, and parasitologic parameters including genomic signatures of selection during careful weekly follow-up visits for 42 days. Volunteers will be randomized on day 3 to either a single 45mg dose of primaquine or no sexual stage therapy to evaluate effects of primaquine on the sexual stages of malaria (gametocytes) and potential transmissibility of infection to Anopheles mosquitoes as compared to those not treated with primaquine.
Study Started
Dec 31
2012
Primary Completion
Dec 31
2014
Study Completion
Jun 30
2016
Anticipated
Last Update
Jul 15
2015
Estimate

Drug DHA-piperaquine and Primaquine

Subject will be enrolled in open label fashion to a 3-day treatment course of DHA-piperaquine (DP) by directly observed therapy (DOT, all patients will receive a total of 9 tablets containing 40mg DHA and 320mg of piperaquine in divided doses at 0, 24 and 48 hours (3 tablets once per day) for the 3 day course. At completion of DP treatment volunteers will be randomized in an open label fashion to receive a single 45 mg dose of primaquine or no therapy.

DHA-piperaquine with Primaquine Active Comparator

3-day treatment course of DHA-piperaquine with 45mg single dose primaquine

DHA-piperaquine without Primaquine Active Comparator

3-day treatment course of DHA-piperaquine

Criteria 

Inclusion Criteria:

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 Criteria:

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
No Results Posted