Single dose malaria therapy under trial at KHRC

By Maame Efua Moses | Posted: Thursday, December 13, 2007

Kintampo Health Research Centre (KHRC) is undertaking a study aimed to obtain a safe, effective and affordable Artemisinin-based Combination Therapy (ACT) for the treatment of uncomplicated Plasmodium falciparum malaria, especially in Africa.

Kweku Poku Asante, Co-Principal Investigator of KHRC in an interview with ADM explained that the study is a multi-center study being carried out in five African countries including Ghana.

He said KHRC is expected to enroll one hundred (100) study participants out of a total sample size of one thousand, three hundred ninety-five thousand (1395) subjects. The study population comprises children and young adolescents from 12months of age to 14 years who have uncompleted malaria.

Mr. Asante stated that the study started in January 2007 and by end of June the Centre has recruited 193 participants.

He said the purpose of the study is to test the safety and the effectiveness of a new drug called CDA (Lapdap-artesunate) in the treatment of uncomplicated plasmodium falciparum malaria.

He said CDA is a combination of LAPDAP (chlorproguanil-dapsone) and Artesunate derived from artemisinin.

He stated that though LAPDAP has been approved for the treatment of uncomplicated Plasmodium falciparum malaria across sub-Saharan Africa, the investigators of this trial posit that the addition of an artemisinin derivative, artesunate, will provide additional population benefits over LAPDAP alone.

He said that Artemether-lumefantrine (Coartem) which is the only available fixed-dose Artemisinin-based Combination Therapy would be tested alongside CDA to demonstrate the-inferiority of CDA in terms of efficacy at 28 days after treatment.

He said studies have proved that it more easy for people to take one drug than dosage.

With this particular study, the centre sort approval from the Food and Drugs Board to carry out the study.

Again, ethnical approvals were also obtained from ethics committees of KHRC and London School of Hygiene and Tropical Medicine. He said Case Report Forms (CRFs) as well as Standard Operating Procedures (SOPs) were developed.

Kweku Poku Asante, said community entry activities involving consultation with chiefs and opinion leaders as well as community sensitization were carried out. Facility-based screening and recruitment of study participants started in November 2006. From the design of the study, recruitment will end when the target numbers are achieved.

He said currently data is being carried out and hope to end in next year 2008. The study would be audited by the Food and Drugs Board. He said KHRC would discuss with Malaria Control Programme on interventions.

“We hope that at the end of the trial. We will be able to provide an alternate to Artemether-lumefantrine (Coartem)”.