Clinical trial NCT01392014: Dihydroartemisinin-piperaquine and Primaquine for Uncomplicated Plasmodium Falciparum Cases
Official title: Effectiveness of Dihydroartemisinin-piperaquine With or Without Primaquine on Gametocytes Plasmodium Falciparum in Mesoendemic Area of Indonesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Malaria
Keywords: malaria
DHP
PQ
gametocytes
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2011-07-12
Enrollment: 374
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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:

Eligibility 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.

Primary outcomes:
measure: Development of sexual stages of P.falciparum
timeFrame: 42 days post treatment
Secondary outcomes:
measure: Clearance of asexual stages P.falciparum
timeFrame: 42 days post treatment
Other outcomes:
Locations:
city: Lampung
country: Indonesia
facility: Hanura Primary Health Center
state: Sumatra
Study officials:
affiliation: Univesity of Indonesia
name: Inge Sutanto, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sutanto I, Suprijanto S, Kosasih A, Dahlan MS, Syafruddin D, Kusriastuti R, Hawley WA, Lobo NF, Ter Kuile FO. The effect of primaquine on gametocyte development and clearance in the treatment of uncomplicated falciparum malaria with dihydroartemisinin-piperaquine in South sumatra, Western indonesia: an open-label, randomized, controlled trial. Clin Infect Dis. 2013 Mar;56(5):685-93. doi: 10.1093/cid/cis959. Epub 2012 Nov 21.