Dihydroartemisinin-piperaquine and Primaquine for Uncomplicated Plasmodium Falciparum Cases (DHP+PQ)

University of Indonesia (UI)

Status and phase

Completed

Phase 4

Conditions

Malaria

Treatments

Drug: dihydroartemisinin-piperaquine + primaquine

Drug: dihydroartemisinin-piperaquine

Study type

Interventional

Funder types

Other

Identifiers

NCT01392014

45114 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

The study was conducted in Hanura Primary Health Center, Padang Cermin district, Lampung province (105°45'-103°48'E and 3°45'-6°45'S) located at the southern end of Sumatra island.

The study subjects received either 3 day doses of dihydroartemisinin-piperaquine with or without 1 day of primaquine according to their body weight.

Patients with fever or history of fever within the past 24 hours were screened by microscopic examination of Giemsa-stained thick blood films to detect P. falciparum infection.

All subjects were allocated by open-label randomization to receive DHP alone (on Day 0 to Day 2) or DHP plus a single dose of PQ (Day 3). The procedures of drug administration in the study were as follows:

Enrollment

374 patients

Sex

All

Ages

4+ years old

Volunteers

No Healthy Volunteers

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.