A Randomised Comparative Study to Assess the Efficacy and Tolerability of Blood Schizonticidal Treatments With Artesunate Amodiaquine Winthrop® / Coarsucam (ASAQ) Versus Chloroquine (CQ) for Uncomplicated Plasmodium Vivax Monoinfection Malaria
Overview
- Phase
- Phase 3
- Intervention
- ARTESUNATE + AMODIAQUINE
- Conditions
- Malaria
- Sponsor
- Sanofi
- Enrollment
- 380
- Locations
- 1
- Primary Endpoint
- Assessment of clinical and parasitological efficacy based on temperature and parasitemia after Polymerase chain reaction (PCR) correction
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
artesunate/amodiaquine
artesunate (AS) / amodiaquine (AQ) as fixed dose combination 1 tablet of AS 25mg/ AQ 67,5mg or AS 50mg/AQ 135mg or AS 100mg/ AQ 270mg or 2 tablets of AS 100mg/ AQ 270mg dose according to bodyweight Once daily 3 days of treatment
Intervention: ARTESUNATE + AMODIAQUINE
chloroquine
150mg tablets 25mg/kg in 3 days (10mg/kg on day 1 and 7,5 mg/kg on days 2 and 3) dose according to bodyweight Once daily 3 days of treatment
Intervention: Chloroquine
Outcomes
Primary Outcomes
Assessment of clinical and parasitological efficacy based on temperature and parasitemia after Polymerase chain reaction (PCR) correction
Time Frame: 28 days
Secondary Outcomes
- 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)
- 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)
- Change from baseline in Haemoglobin levels(Day 7, Day 28)
- 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)