Efficacy and Tolerability of Artesunate Amodiaquine Versus Chloroquine in the Treatment of Uncomplicated Plasmodium Vivax Malaria
Information source: Sanofi
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Malaria
Intervention: ARTESUNATE + AMODIAQUINE (Drug); Chloroquine (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Sanofi Official(s) and/or principal investigator(s):
Clinical Sciences & Operations, Study Director, Affiliation: Sanofi
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
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Assessment of clinical and parasitological efficacy based on temperature and parasitemia after Polymerase chain reaction (PCR) correction
Secondary outcome: 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 D28Number of patients without parasite Number of patients without fever Number of patients with gametocytes Change from baseline in Haemoglobin levels Incidence and severity of adverse events collected ECG (QTc) changes in patients group aged >= 10 years from baseline Assessment of biological tolerability (bilirubin, ALAT, Creatinine, Leukocytes, Neutrophils and platelets count) from baseline
Detailed description:
Each patient will be followed for a period of 42 days
Eligibility
Minimum age: 6 Months.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Administrative office, Sao Paulo, Brazil
Additional Information
Starting date: January 2012
Last updated: July 17, 2013
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