Study of SAR97276A in the Treatment of Uncomplicated and Severe Malaria in Adults and Children.

June 15, 2010 updated by: Sanofi

A Multicenter, Open Label, Efficacy and Safety Study of Parenteral SAR97276A in the Treatment of Symptomatic Uncomplicated and Severe Malaria in Adults and Children

The objective of the study is to assess the efficacy and safety of SAR97276A in severe malaria in pediatric patients. Before treating pediatric patients with severe malaria, the efficacy and safety of SAR97276A will be first tested in adult patients, then in pediatric patients, with uncomplicated malaria.

The safety and the concentration of SAR97276A in blood and plasma will be assessed in adult and pediatric patients.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The treatment will be administered by intramuscular or intravenous route depending on the cohort. The treatment will be administered as single dose or 3-day repeated dose. The patients will be hospitalized for 3 days and followed up to 28 days following study treatment.

Study Type

Interventional

Enrollment (Actual)

113

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Benin
      • Porto Novo, Benin
        • Sanofi-Aventis Administrative Office
  • Burkina Faso
      • Ouagadougou, Burkina Faso
        • Sanofi-Aventis Administrative Office
  • Gabon
      • Libreville, Gabon
        • Sanofi-Aventis Administrative Office
  • Tanzania
      • Dodoma, Tanzania
        • Sanofi-Aventis Administrative Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patients with uncomplicated malaria will be enrolled in cohort 1
  • Pediatric patients with uncomplicated malaria will be enrolled in cohort 2
  • Pediatric patients with severe malaria will be enrolled in cohort 3
  • Plasmodium falciparum malaria confirmed in blood smear
  • Fever within the last 24 hours.

Exclusion Criteria:

  • Treatment with an antimalarial agent within 72h of screening
  • Severe concomitant disease
  • Pregnant or breast-feeding women
  • Women of child bearing potential not protected by an effective method of birth control

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1
Adult patients with uncomplicated malaria
Drug: SAR97276A
Dose based on body weight
Experimental: Cohort 2
Pediatric patients with uncomplicated malaria
Drug: SAR97276A
Dose based on body weight
Experimental: Cohort 3
Pediatric patients with severe malaria
Drug: SAR97276A
Dose based on body weight

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Combination of fever clearance, general condition improvement at 48h parasite reduction at 72h and no need for rescue therapy at 72h
Time Frame: 3 initial days
3 initial days

Secondary Outcome Measures

Outcome Measure
Time Frame
Parasite reduction
Time Frame: 3 initial days (72h)
3 initial days (72h)
Safety assessment
Time Frame: 28 days post 1st study drug administration
28 days post 1st study drug administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

August 20, 2008

First Submitted That Met QC Criteria

August 20, 2008

First Posted (Estimate)

August 21, 2008

Study Record Updates

Last Update Posted (Estimate)

June 16, 2010

Last Update Submitted That Met QC Criteria

June 15, 2010

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACT10004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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