Malaria
Conditions
Brief summary
The primary objective of this study is to demonstrate the non-inferiority of Polymerase Chain Reaction (PCR)-adjusted adequate clinical and parasitological response to artesunate plus amodiaquine at Day 28 in two groups of patients treated at the beginning of an artesunate plus amodiaquine implementation program and 24 months later. The secondary objectives are Clinical and biological tolerability Evolution of gametocyte carriage Proportion of patients without fever at Day 3 Proportion of patients without parasite at Day 3 Treatment compliance Impact of implementation on anemia Measure of parasite sensibility to amodiaquine
Interventions
Artesunate + Amodiaquine fixed dose combination
Sponsors
Medicines for Malaria Venture
Sanofi
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Body weight \>=5kg * Plasmodium falciparum infection with parasite density \> 2000/µL * Fever or history of fever * Able to be treated by oral route * No signs of severe malaria * No known allergy to study drugs * No other severe illnesses or underlying diseases * No known pregnancy or negative urinary pregnancy test for women of child bearing age * No participation in another ongoing clinical study 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 |
|---|---|
| Polymerase chain reaction (PCR)-corrected and uncorrected clinical and parasitological cure rate (ACPR) | Day 28 |
Secondary
| Measure | Time frame |
|---|---|
| Number of patients without fever | Day 3 |
| Number of patients without parasite | Day 3 |
| Number of gametocytes | Day 3, Day 7, Day 14, Day 21 and Day 28 |
| Evolution of in vitro resistance rate | Day 3, Day 7, Day 14, Day 21 and Day 28 |
Countries
Côte d’Ivoire
Outcome results
None listed