Antimalarial Drug Resistance With Assessment of Transmission Blocking Activity

• Register: ClinicalTrials.gov
• Last refreshed on: 3 August 2015
• Main ID: NCT01849640
• Date of registration: 27/02/2013
• Prospective Registration: No
• Primary sponsor: David Saunders
• Public title: Antimalarial Drug Resistance With Assessment of Transmission Blocking Activity
• Scientific title: Active Surveillance for P. Falciparum Drug Resistance With Assessment of Transmission Blocking Activity of Single Dose Primaquine in Cambodia
• Date of first enrolment: December 2012
• Target sample size: 150
• Recruitment status: Suspended
• URL: https://clinicaltrials.gov/show/NCT01849640
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

Cambodia

Contacts

• Name: David Saunders, MD, MPH
• Affiliation: Dept. of Immunology and Medicine, Armed Forces Research Institute of Medical Sciences (AFRIMS)

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Uncomplicated Plasmodium Falciparum Malaria

Intervention(s)

Drug: DHA-piperaquine and Primaquine

Primary Outcome(s)

Clinical efficacy of DP [Time Frame: 3 years]

Secondary Outcome(s)

Efficacy of Primaquine to treat sexual stage gametocyte infection and prevent transmission of P. falciparum gametocytes to mosquitoes. [Time Frame: 3 years]

Secondary ID(s)

HRPO Log Number A-17145

WRAIR#1877

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Centre for Parasitology, Entomology and Malaria Control, Cambodia

Royal Cambodian Armed Forces

US Department of Defense Armed Forces Health Surveillance Center