Malaria
Conditions
Brief summary
Primary Objective: \- To demonstrate the non-inferiority of corrected adequate clinical and parasitological response at Day 28 of Artesunate Amodiaquine (ASAQ) versus chloroquine Secondary Objectives: * To assess the non inferiority on the same way as the main criteria: * at Day 28 before corrected cure rate * at Day 14 and Day 42 before and after corrected cure rate * To compare the two groups of treatment in terms of: * Efficacy: * Proportion of aparasitaemic patients at 24, 48 an 72 hours * Proportion of afebrile patients at 24, 48 and 72 hours * Percentage of gametocyte carriers during follow-up * Evolution of the mean of gametocytes during the 42 days of follow-up * Evolution of haemoglobin value between Day 0 and Day 7, Day 0 and Day 28 * Clinical and biological tolerability: * Proportion of any adverse event * Biological safety: haematology (Red blood cells, Haemoglobin, White Blood Cells, neutrophils, platelets), biochemistry (creatinine, transaminases (alanine amino transferase/ALT), bilirubins) * ECG (electro encephalogram) (Day 0, Day 3,Day 28) only for patients 10 years old and above
Detailed description
Each patient will be followed for a period of 42 days
Interventions
Pharmaceutical form: Route of administration:
DRUGChloroquine
Pharmaceutical form:tablet Route of administration: oral
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults and children over 6 months old and bodyweight \> 5 kg * Able to be treated by oral route * Axillary temperature ≥ 37,5 C or history of fever during the previous 2 days * Symptomatic biologically confirmed Plasmodium vivax mono-infection, with parasitemia from 250 to 100000 parasites /µl of blood * Written informed consent of the patients and for children written informed consent of the parents/legal representative for children. Children able to understand the objectives and the risks of the study will sign an assent form.
Exclusion criteria
* Known project of leaving the investigator site area during the follow-up period (42 days) * Hypersensitivity to one of the investigational medicinal products or to any of the excipients * Intake of an antimalarial treatment in the previous 30 days * History of hepatic and (or) haematological impairment during treatment with amodiaquine * Blurred vision suggesting a retinopathy * Presence of at least one danger sign of malaria * Pregnant or breast-feeding women * Women with childbearing potential not willing to use an effective contraceptive method(s) for the duration of the study * Known severe concomitant or underlying disease The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of clinical and parasitological efficacy based on temperature and parasitemia after Polymerase chain reaction (PCR) correction | 28 days |
Secondary
| Measure | Time frame |
|---|---|
| Number of patients without parasite | up to a maximum of 42 days |
| Number of patients without fever | up to a maximum of 42 days |
| Number of patients with gametocytes | up to a maximum of 42 days |
| Assessment of clinical and parasitological efficacy based on temperature and parasitemia before and after PCR correction at D14 and D42 and before PCR correction at D28 | up to a maximum of 42 days |
| Incidence and severity of adverse events collected | up to a maximum of 42 days |
| ECG (QTc) changes in patients group aged >= 10 years from baseline | Day 3, Day 28 |
| Assessment of biological tolerability (bilirubin, ALAT, Creatinine, Leukocytes, Neutrophils and platelets count) from baseline | up to a maximum of 42 days |
| Change from baseline in Haemoglobin levels | Day 7, Day 28 |
Countries
Brazil
Outcome results
None listed