Malaria Infections and Infestations Malaria
Conditions
Interventions
The overall trial start and end dates above refer to the efficacy/safety study. The overall trial start and end dates of the study with PK are September 2006 and December 2006, respectively.
Patient
2 tablets per day for children aged 1-5.
2. AS (50 mg) + AQ (153 mg). 1/2 AS tablet and 1/2 AQ tablet per day for children aged 0-11 months
1 AS tablet and 1 AQ tablet per day for children aged 1-5 years.
Duration of treatment: 3 consecutive days
Sponsors
Drugs for Neglected Diseases initiative (DNDi) (Switzerland)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient between 6 months and = 5 kg (to help the assay of artesunate) 3. P. falciparum single-species infection with positive parasitemia (asexual forms) greater than 1,000 parasites per microlitre of blood 4. Fever (uncorrected axillary temperature >37.5°C) on Day 0 in children 5. No other obvious cause for the fever (e.g., respiratory [ear, nose and/or throat] infection) 6. Consent of the child's family or guardian
Exclusion criteria
Exclusion criteria: 1. Signs of life threatening and/or severe malaria 2. Other underlying diseases (cardiac, renal, hepatic, severe malnutrition) 3. Allergy to the study drugs 4. Treatment with amodiaquine within the past 7 days, or with artemisinin derivatives within the past 3 days (72 h) 5. Complete cure with an antimalarial within the past 7 days (with the exception of chloroquine) 6. On-going treatment with an antibiotic with antimalarial action (e.g. co-trimoxazole, tetracycline, or macrolide)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To show the non-inferiority in terms of efficacy of the fixed-dose combination AQ/AS compared to both drugs given separately. Efficacy will be measured by: 1. Cure rate (elimination of parasitemia without relapse) 28 days after the beginning of treatment 2. Parasitemia reduction rate and parasite clearance time (Duration of follow-up: 28 days) 3. Fever clearance time (Duration of follow-up: 28 days) 4. Gametocyte carrier rate (Duration of follow-up: 28 days) | — |
Secondary
| Measure | Time frame |
|---|---|
| Tolerance and safety. The following will be evaluated at each visit until day 28 (Day 0, 1, 2, 3, 7, 14, 21 and 28): 1. Clinical tolerance and safety, measured by the following: 1.1. Signs/symptoms which may appear after the treatment 1.2. Serious adverse events 1.3. In study with PK only: ElectroCardioGram (ECG) anomalies (prolonged QT interval). Measured at day 0, 2 and 28 2. Biological tolerance and safety. The following will be measured by blood tests at day 0, 7 and 28 (If abnormal values are found at day 7 or day 14, the measurements will also be carried out on day 14 and 21 in addition to day 28): 2.1. Biochemical tests: a. ALanine AminoTransferase [ALAT] b. Bilirubin c. Creatinine 2.2. Hematological tests: a. Complete Blood Count [CBC] 3. In study with PK only: PK parameters (Population PK, AUC, Cmax, Tmax, T1/2) | — |
Countries
Burkina Faso
Outcome results
None listed