Kintampo Trial of Combination Therapy for Malaria

• Status: Completed
• Trial end date: 2006-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Case management is one of the key strategies for malaria control in most endemic countries. Plasmodium falciparum malaria is becoming resistant to commonly used and cheap antimalarial drugs such as chloroquine, amodiaquine, and sulfadoxine-pyrimethamine (SP). Thus the safety and efficacy of new anti-malarial drugs need to be tested in sites with well-characterised malariometric indices in order to make appropriate treatment policies.

Artemisinin-based combination chemotherapies have been documented to consistently produce faster relief of clinical symptoms and parasite clearance in uncomplicated falciparum malaria than any other currently used antimalarial drugs. So far, artesunate-amodiaquine (AS-AQ) and artemether-lumefantrine (AR-LM) are the only two registered fixed-dose artemisinin combination chemotherapies produced at industrial scale, with good manufacturing practices and already used in Africa. Several African countries, including Ghana, are therefore introducing either AS-AQ or AR-LM as first-line antimalarials or evaluating the case for such a change. Clearly, a direct comparison of both the safety and efficacy profiles of the two combinations under different epidemiological conditions is urgently needed to guide informed decisions on the most appropriate antimalarial first-line treatment regimen.

This study aims to evaluate the efficacy and safety of artesunate-amodiaquine combination therapy, artemether-lumefantrine, and artesunate-lapdap in an open-labelled, randomised, non-inferiority drug trial.

The study results will inform future decisions on first- and second-line treatments for uncomplicated P. falciparum malaria with respect to efficacy and safety in Ghana.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gates Malaria Partnership; London School of Hygiene and Tropical Medicine
• Collaborator: Kintampo Health Research Centre, Ghana
• Treatments: Amodiaquine; Artemether-lumefantrine combination; Artemether, Lumefantrine Drug Combination; Artemisinins; Artesunate

Criteria

Inclusion Criteria:

• Age 6 months to 10 years

• Body weight >5 kg

• Uncomplicated P. falciparum malaria

• Mono-infection with P. falciparum

• Asexual parasite density 2,000 to 200,000 parasites/µl

• Haemoglobin ≥7.0 g/dL

• Axillary temperature ≥37.5ºC or history of fever in preceding 24 hr

• Ability to tolerate oral therapy

• Residence in study area

Exclusion Criteria:

• Haemoglobin <7.0 g/dL

• Leucocyte count: >15,000/µL

• G6PD deficiency

• Mixed malaria infections

• Danger signs (unable to drink; repeated vomiting; recent history of convulsions; lethargic or unconscious state; unable to stand up or to sit) and signs of severe malaria as defined by WHO

• Any other severe underlying disease (cardiac, renal, hepatic diseases, malnutrition, known HIV infection)

• Concomitant disease masking assessment of response, e.g. known or suspected hearing impairments