Dihydroartemisinin-piperaquine and Primaquine for Uncomplicated Plasmodium Falciparum Cases

Phase 4

Completed

• Conditions: Malaria
• Interventions: Drug: dihydroartemisinin-piperaquine; Drug: dihydroartemisinin-piperaquine + primaquine

• Registration Number: NCT01392014
• Lead Sponsor: Indonesia University

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:

Study Timeline

• Status Verified: 2008-08
• Study Start: 2008-12
• Primary Completion: 2010-03
• Study Completion: 2010-10
• Study First Submitted: 2011-06-24
• Study First Submitted QC: 2011-07-08
• Last Update Submitted: 2011-07-08
• Study First Posted: 2011-07-12
• Last Update Posted: 2011-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 374

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dihydroartemisinin-piperaquine	dihydroartemisinin-piperaquine	-
Dihydroartemisininpiperaquine primaquine	dihydroartemisinin-piperaquine + primaquine	-

Primary Outcome Measures

Name	Time	Method
Development of sexual stages of P.falciparum	42 days post treatment	Finger prick blood samples are collected for malaria blood smear. Thick and thin blood smears were stained with 3% Giemsa solution for 40 minutes and were read under binocular microscope with 1,000X magnification.

Secondary Outcome Measures

Name	Time	Method
Clearance of asexual stages P.falciparum	42 days post treatment	Finger prick blood samples are collected for malaria blood smear. Thick and thin blood smears were stained with 3% Giemsa solution for 40 minutes and were read under binocular microscope with 1,000X magnification.

Trial Locations

Locations (1)

Hanura Primary Health Center; 🇮🇩 Lampung, Sumatra, Indonesia