Malaria
Conditions
Interventions
Artesunate-amodiaquine tablets 25mg/67,5 mg of Artesunate/Amodiaquine
Artemether-Lumefantrine Tablets 20 mg of Artemether and 120 mg of Lumefantrine
Sponsors
Jean-Pierre Van geertruyden
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: In order to be eligible, patients should satisfy the following inclusion criteria: 1. Males and Females aged between 12 months and 59 months inclusive. 2. Body weight of 9 Kg and above. 3. Microscopically confirmed, mono-infection of Plasmodium falciparum (parasitaemia 2,000/microliter to 200,000/microliter). 4. Fever (tympanic temperature at ¿ 38.0°C) or history of fever in the previous 24 hours. 5. Haemoglobin value ¿ 6.0 g/dl; 6. Signed informed consents by the parents or guardians. 7. Parents¿ or guardians¿ willingness and ability to comply with the study protocol for the duration of the study.
Exclusion criteria
Exclusion criteria: Patients with at least one of the following criteria will be excluded: 1. Participation in any other investigational drug study (antimalarial or others) during the previous 30 days. 2. Known hypersensitivity and previous Serious Adverse Events related to the study drugs. 3. Severe malaria( WHO 2000) or 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. 4. Presence of intercurrent illness or any condition (cardiac, renal, hematologic, hepatic diseases) which would place the subject at undue risk or interfere with the results of the study, including known G6PD deficiency. 5. Patients who are taking drug which may prolong the QT (imidazole and triazole, antifungal agent). 6. Severe malnutrition (defined as weight for height <70% of the median NCHS/WHO reference). 7. Ongoing prophylaxis with drugs having antimalarial activity such as cotrimoxazole for the prevention of Pneumocisti carini pneumonia in children born to HIV+ women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PCR adjusted efficacy: the proportion of children with PCR adequate clinical and parasitological response at day 28 (ACPR28A): all early failures before day 7 plus the recurrent parasitaemias detected later and classified by genotyping as recrudescence. | — |
Secondary
| Measure | Time frame |
|---|---|
| PCR unadjusted efficacy: the proportion of children without (PCR not adjusted) treatment failure (TF28U): all treatment failures detected during the active follow up, regardless of genotyping;Clinical efficacy: all clinical treatment failures detected during the 42 days follow up for the first line treatment, with and without PCR adjustment. As no active monitoring of parasitaemia after day 3 is planned this includes Early Treatment Failure and Late Clinical Failure following WHO criteria;Fever clearance time (FCT): Fever clearance time is defined as the time (in days) from the time of randomization to the first two consecutive measurements on 2 different days of tympanic temperature below 38.0°C.;Asexual parasite clearance time (PCT): Asexual parasite clearance time is defined as the time (in days) from time of randomization to 2 consecutive negative blood slides (collected at different days). The time to the event will be taken as the time to the first negative slide.;Gametocytaemia (prevalence and density) ;Hb changes | — |
Countries
Democratic Republic of the Congo, Uganda
Contacts
Public ContactJoachim Y Doua
Research assistant
Outcome results
None listed