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Anti-parasitic Activity and Safety Assessment of SAR97276A in Children With Uncomplicated Malaria

NCT01445938 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2012-12-13

No results posted yet for this study

Summary

Primary Objective:

To assess the antiparasitic activity of intramuscular (IM) SAR97276A based on parasite reduction ratio at 72 hours in pediatric patients with uncomplicated malaria

Secondary Objectives:

* To assess the evolution of clinical signs and symptoms (including the need for a rescue therapy) in pediatric patients with uncomplicated malaria receiving SAR97276A with reference to Artemisinin-Based Combination Therapy (ACTs)
* To assess the pharmacokinetics profile of SAR97276A in pediatric patients with uncomplicated malaria
* To assess the safety profile of SAR97276A in pediatric patients with uncomplicated malaria
* To assess the pharmacokinetic-pharmacodynamic relationship of SAR97276A

Conditions

Interventions

DRUG

SAR97276A

Pharmaceutical form:solution for injection Route of administration: intramuscular

DRUG

arthemeter + lumefantrine (ACTs)

Pharmaceutical form:tablet Route of administration: oral

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2012-01-31
Completion
2012-01-31

Countries

  • Benin
  • Burkina Faso
  • Gabon
  • Kenya

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT01445938 on ClinicalTrials.gov