Overview

Dihydroartemisinin-piperaquine and Primaquine for Uncomplicated Plasmodium Falciparum Cases

Status:
Completed
Trial end date:
2010-10-01
Target enrollment:
0
Participant gender:
All
Summary
Artemisinin-based combination therapy (ACT) has been known to be controversial for stopping malaria transmission.The addition of primaquine (PQ) - the only drug commercially available that kills mature transmission stage - to such treatments might be necessary to eliminate this stage. A study is conducted to evaluate the efficacy of dihydroartemisinin-piperaquine (DHP) regimens with or without PQ on the sexual and asexual stages of P. falciparum in Sumatra, Indonesia.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Indonesia University
Treatments:
Artemisinins
Artenimol
Dihydroartemisinin
Piperaquine
Primaquine
Criteria
Inclusion Criteria:

- age ≥ 4 years old

- parasite count ≥ 1,000 asexual parasites/µL

- normal glucose-6-phosphate dehydrogenase enzyme level based on qualitative test
(Trinity Biotech® no 203, USA)

- hemoglobin level ≥ 8 gr/dL as measured by Hemoque® apparatus;

- have the ability to return for 42-day-follow up and

- willingness to sign the informed-consent form.

Exclusion Criteria:

- are infected with other r plasmodium species

- have only gametocytes of P. falciparum;

- are pregnant - measured by positive result on HCG urine test and/or breastfeeding
women

- present signs of pitting edema on both legs as a sign of malnutrition

- have complicated or severe malaria, other chronic diseases or history of drug
allergies.