Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2025-12-24 @ 3:05 PM
NCT ID:
NCT01755559
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).
Study:
NCT01755559
Study Brief:
Protocol Section:
NCT01755559