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

Muraz Center

Status and phase

Completed

Phase 4

Conditions

Malaria

Treatments

Drug: Artemether-lumefantrine

Drug: Artesunate-amodiaquine

Study type

Interventional

Funder types

Other

Identifiers

NCT00808951

Malactres-BF

Details and patient eligibility

About

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.

Full description

Plasmodium falciparum resistance to antimalarial drugs represents the major drawback and obstacle for controlling malaria in endemic countries; that's why most sub-Saharan countries have changed their antimalarial drug policy to Artemisinin Containing Therapies (ACT), which produce a rapid clinical and parasitological cure, reduce gametocyte carriage rate and are generally well tolerated. Burkina Faso has recently changed its policy for the treatment of uncomplicated malaria, from Chloroquine to Artemether-Lumefantrine (AL) and Artesunate-Amodiaquine (AQ+AS). However, there are still little available data on safety and efficacy of these treatments in Burkina Faso; a recent study carried out in Bobo Dioulasso showed that both treatments were extremely efficacious (adjusted treatment failure less than 5%) but with AL showing significantly high occurrence of recurrent infections during the 28-day follow up period. The higher risk for recurrent infections for AL was confirmed in a subsequent trial comparing AL with AQ-SP and dihydroartemisinin-piperaquine, but so far no direct comparison between AQ+AS and AL has been completed, though a study in Nanoro, near Ouagadougou, is ongoing. Thus, the present study aims at comparing the in vivo safety and efficacy of AL and AS-AQ (42-day follow-up),AND at comparing the in vitro sensitivity of the different ACT components, in patients with recurrent infection, with the results obtained in vivo.

Enrollment

440 patients

Sex

All

Ages

6 months to 15 years old

Volunteers

No Healthy Volunteers

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)