In Vivo and in Vitro Efficacy of Antimalarial Treatments in Children in Burkina Faso

• Status: Completed
• Trial end date: 2011-02-01
• Target enrollment: 0
• Participant gender: All

Summary

Resistance to antimalarial drugs represents a major obstacle for controlling malaria in endemic countries, so that most sub-Saharan countries have changed their antimalarial drug policy to the new Artemisinin Containing Therapies. Burkina Faso has changed its policy for uncomplicated malaria to Artemether-Lumefantrine (AL) and Artesunate-Amodiaquine (AQ+AS), but there are still little available data on safety and efficacy of these treatments in Burkina Faso; both treatments have shown to be efficacious, but AL seems to have higher occurrence of recurrent malaria infections during a 28-day follow up period. Thus, this study aims at comparing the safety and efficacy of AL and AS-AQ (42-day follow-up), AND also at comparing their in vitro sensitivity, in patients with recurrent infection, with the results obtained in vivo.

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

Details

• Lead Sponsor: Centre Muraz
• Collaborator: Institute of Tropical Medicine, Belgium
• Treatments: Amodiaquine; Antimalarials; Artemether; Artemether-lumefantrine combination; Artemether, Lumefantrine Drug Combination; Artemisinins; Artesunate; Lumefantrine

Criteria

Inclusion Criteria:

• Age 6 - 59 months

• Weight > 5 kg

• Mono-infection with P. falciparum

• Parasitemia of 4,000-200,000 asexual parasites per µl

• Fever: > 37.5 °C or history of fever in the preceding 24 hours

• Haemoglobin > 5.0 g/dl

• Signed informed consent by the parents or guardians

• Parents' or guardians' willingness and ability to comply with the study protocol for the duration of the trial.

Exclusion Criteria:

• Participation in any other clinical trial during the previous 30 days

• Known hypersensitivity to the study drugs

• Severe and/or complicated malaria (cases will be referred to Bobo-Dioulasso University hospital for treatment)

• Danger signs: not able to drink or breast-feed, vomiting (> twice in 24hours), recent history of convulsions (>1 in 24h), unconscious state, unable to sit or stand;

• Known intercurrent illness or any condition which would place the subject at undue risk or interfere with the results of the study.

• Severe malnutrition (weight for height <70% of the median NCHS/WHO reference)