Evaluation of 4 Artemisinin-based Combinations for Treating Uncomplicated Malaria in African Children

Summary

The main objective is to compare the safety and efficacy of 4 artemisinin-based combinations (ACT) \[amodiaquine-artesunate (AQ+AS), dihydroartemisinin-piperaquine (DHAPQ), artemether-lumefantrine (AL) and chlorproguanil/dapsone plus artesunate\] for single and repeat treatments of uncomplicated malaria in children. Safety will be determined by registering adverse events and grading, laboratory, and vital signs evaluations. Their incidence will be compared between the different study arms.

TO BE NOTED: following GlaxoSmithKline decision to discontinue the clinical development of the fixed-doses combination of Lapdap (Chlorproguanil-Dapsone) and artesunate, the Lapdap plus Artesunate arm was immediately discontinued in this study, on 17th February 2008. A formal amendment has been submitted to all the concerned ECs and competent authorities. The leading EC approved the amendment on 2nd June 2008.

TO BE NOTED: since the batches of the study drug DHAPQ expire at the end of October 2008, and because of the unavailability of a new batch of DHAPQ from the manufacturer, the recruitment in the DHAPQ arm had to be discontinued on 30th October 2008. A formal amendment has been submitted to all the concerned ECs and competent authorities.

Conditions

• Fever
• Malaria

Interventions

DRUG

amodiaquine-artesunate (ASAQ)

A fix-dose combination tablet containing artesunate-amodiaquine in three different dosages, to be used according to patient age and weight: 25mg/67.5mg; 50mg/135mg; 100mg/270mg

DRUG

dihydroartemisinin-piperaquine (DHAPQ)

DHAPQ tablets contain either 20/160mg or 40/320mg of dihydroartemisinin (DHA) and piperaquine phosphate (PQ) respectively.

DRUG

artemether-lumefantrine (AL)

Tablets containing 20 mg of Artemether and 120 mg of Lumefantrine.

DRUG

Lapdap (Chlorproguanil-Dapsone) + artesunate (AS)

Lapdap tablets contain 15/18.75mg or 80/100mg of Chlorproguanil Hydrochloride and Dapsone, respectively. Arsumax® tablets contain 50mg Artesunate. TO BE NOTED: following GlaxoSmithKline decision to discontinue the clinical development of the fixed-doses combination of Lapdap (Chlorproguanil-Dapsone) and artesunate, the Lapdap plus Artesunate arm was immediately discontinued in this study, on 17th February 2008. A formal amendment has been submitted to all the concerned ECs and competent authorities.The leading EC approval was obtained on 2nd June 2008.

Sponsors & Collaborators

• Liverpool School of Tropical Medicine

  collaborator OTHER

• East African Network for Monitoring Antimalarial Treatment

  collaborator NETWORK

• Centre Muraz

  collaborator OTHER

• University of Calabar

  collaborator OTHER

• Tropical Diseases Research Centre, Zambia

  collaborator OTHER_GOV

• University Hospital Tuebingen

  collaborator OTHER

• Albert Schweitzer Hospital

  collaborator OTHER

• Uganda Malaria Surveillance Project

  collaborator OTHER

• Mbarara University of Science and Technology

  collaborator OTHER

• Ministry of Health, Rwanda

  collaborator OTHER_GOV

• University of Barcelona

  collaborator OTHER

• Centro de Investigacao em Saude de Manhica

  collaborator OTHER

• Institute of Tropical Medicine, Belgium

  lead OTHER

Principal Investigators

• UmbertoC D'Alessandro, MD MsC PhD · Institute of Tropical Medicine Antwerp

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

6 Months

Max Age

59 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-07-31

Primary Completion

2009-12-31

Completion

2009-12-31

Countries

• Burkina Faso
• Gabon
• Mozambique
• Nigeria
• Rwanda
• Uganda
• Zambia

Study Locations