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Efficacy of Three ACTs for the Treatment of Falciparum Malaria in Maradi Niger

NCT01755559 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 663

Last updated 2015-11-30

No results posted yet for this study

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).

Conditions

Interventions

DRUG

Artesunate-amodiaquine

antimalarial ACT

DRUG

Dihydroartemisinin-piperaquine

antimalarial ACT

DRUG

Artemether-lumefantrine

antimalarial ACT

Sponsors & Collaborators

  • Centre de Recherche Médicale et Sanitaire (Cermes), Niamey

    collaborator UNKNOWN

  • Epicentre

    lead OTHER

Principal Investigators

  • Francesco Grandesso, MSc · Epicentre

  • Lynda Woi Messe, MD · Epicentre

  • Ibrahim M Laminou, PhD · Cermes

  • Jean-François Etard, PhD · Epicentre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
6 Months
Max Age
59 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2014-11-30
Completion
2014-11-30

Countries

  • Niger

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01755559 on ClinicalTrials.gov