Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2026-01-29 @ 7:32 AM
Study NCT ID:
NCT01755559
Status:
COMPLETED
Last Update Posted:
2015-11-30
First Post:
2012-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Three ACTs for the Treatment of Falciparum Malaria in Maradi Niger
Sponsor:
Epicentre
Organization:
Study Overview
Official Title:
Efficacy of Artesunate-amodiaquine, Dihydroartemisinin-piperaquine and Artemether-lumefantrine Combination Therapies for the Treatment of Uncomplicated Plasmodium Falciparum Malaria in Children Aged 6 to 59 Months in Maradi, Niger 2012-13
Status:
COMPLETED
Status Verified Date:
2015-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Study treatments:
* Artemether-lumefantrine
* Artesunate-amodiaquine
* Dihydroartemisinin-piperaquine
Location:
Maradi, Niger
Principal Objective:
To measure the clinical and parasitological efficacy of the three artemisinin combination therapies over a period of 42 days from the start of treatment and with polymerase chain reaction assay (PCR) adjustment.
Secondary objectives:
* To determine the blood concentration of the non-artemisinin component of the treatment (lumefantrine, desethylamodiaquine or piperaquine) at day 7
* To assess the incidence of adverse events during the follow-up period;
* To measure speed of parasite clearance
Methods:
In vivo non comparative study as for WHO standardised protocol. The study also measure the concentration of the non-artemisinin component.
Target population:
Children under 5 years of age consulting the integrated health centres of Andoumé and Dix-sept portes in Maradi.
Sample size:
221 patients per study treatment; 663 patients in total.
Treatment allocation:
Random.
Outcomes:
* Early treatment failure,
* Late clinical failure,
* Late parasitological failure,
* Adequate clinical and parasitological response.
Analysis:
* Cumulative success or failure rate (Kaplan-Meier analysis).
* Proportions of early treatment failures, late clinical failures, late parasitological failures, and adequate clinical and parasitological response (called also Per-protocol analysis).
* Artemether-lumefantrine
* Artesunate-amodiaquine
* Dihydroartemisinin-piperaquine
Location:
Maradi, Niger
Principal Objective:
To measure the clinical and parasitological efficacy of the three artemisinin combination therapies over a period of 42 days from the start of treatment and with polymerase chain reaction assay (PCR) adjustment.
Secondary objectives:
* To determine the blood concentration of the non-artemisinin component of the treatment (lumefantrine, desethylamodiaquine or piperaquine) at day 7
* To assess the incidence of adverse events during the follow-up period;
* To measure speed of parasite clearance
Methods:
In vivo non comparative study as for WHO standardised protocol. The study also measure the concentration of the non-artemisinin component.
Target population:
Children under 5 years of age consulting the integrated health centres of Andoumé and Dix-sept portes in Maradi.
Sample size:
221 patients per study treatment; 663 patients in total.
Treatment allocation:
Random.
Outcomes:
* Early treatment failure,
* Late clinical failure,
* Late parasitological failure,
* Adequate clinical and parasitological response.
Analysis:
* Cumulative success or failure rate (Kaplan-Meier analysis).
* Proportions of early treatment failures, late clinical failures, late parasitological failures, and adequate clinical and parasitological response (called also Per-protocol analysis).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: