Dihydroartemisinin-piperaquine and Primaquine for Uncomplicated Plasmodium Falciparum Cases

NCT01392014 | Completed Phase 4

• 1 other identifier: 45114
• Study Type: interventional
• Target: 374
• Locations: 1 country
• Sites: 1

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.

Conditions

Malaria

Keywords

malaria; DHP; PQ; gametocytes

Outcome Measures

Primary Outcomes (1)

• Development of sexual stages of P.falciparum

  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.

  42 days post treatment

Secondary Outcomes (1)

• Clearance of asexual stages P.falciparum

  42 days post treatment

Study Arms (2)

dihydroartemisinin-piperaquine

ACTIVE COMPARATOR

Drug: dihydroartemisinin-piperaquine

Dihydroartemisininpiperaquine primaquine

ACTIVE COMPARATOR

Drug: dihydroartemisinin-piperaquine + primaquine

Interventions

dihydroartemisinin-piperaquine DRUG

This study used fixed-dose tablets of 40 mg dihydroartemisinin and 320 mg piperaquine for each tablet (D-ARTEPP®, Guilin Pharmaceutical Co., Ltd, China. The regimen is based on weight for 3 days (D0, D1 and D2) with maximal dose of 1 x 3 tablets for patients weighing ≥ 41 kg; 1 x 2 tablets for patients weighing 31 - 40 kg, 1 x 1.5 tablets for patients weighing 18 - 30 kg, and 1 X 1 tablet for patients with body weight of 11 - 17 kg.

Also known as: DHP

dihydroartemisinin-piperaquine

dihydroartemisinin-piperaquine + primaquine DRUG

For DHP, treatment was as for Arm dihydroartemisinin piperaquine. A single dose PQ of 0.75 mg/kg BW was provided on Day-3 using 15 mg base PQ tablets (local product by PT Pharos Indonesia, batch no 15306002, produced on 30/05/2008 and expiring on May 2012). The maximal dose was 3 tablets for subjects weighing ≥ 60 kg. The dose range for subjects weighing 10 - 13 kg was 0.5 tablet; 14 - 18 kg was 0.75 tablet; 19 - 23 kg was 1 tablet, 24 -30 kg was 1.5 tablet; 31 - 40 kg was 2 tablets; 41- 49 kg was 2.25 tablet; 50 - 59 kg was 2.5 tablet and ≥ 60 kg was 3 tablets.

Also known as: DHP, PQ

Dihydroartemisininpiperaquine primaquine

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Hanura Primary Health Center

Lampung, Sumatra, Indonesia

Location

Related Publications (1)

• 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.

  PMID: 23175563 DERIVED

MeSH Terms

Conditions

Malaria

Interventions

Primaquine

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Inge Sutanto, MD

  Univesity of Indonesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 24, 2011
• First Posted: July 12, 2011
• Study Start: December 1, 2008
• Primary Completion: March 1, 2010
• Study Completion: October 1, 2010
• Last Updated: July 12, 2011

Record last verified: 2008-08

Locations

ID (1)