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

This study has been terminated.
(In accordance with protocol's predefined criteria and Data Monitoring Committee recommendation due to insufficient level of efficacy)
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00739206
First received: August 20, 2008
Last updated: June 15, 2010
Last verified: June 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Malaria
 Drug: SAR97276A
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Open Label, Efficacy and Safety Study of Parenteral SAR97276A in the Treatment of Symptomatic Uncomplicated and Severe Malaria in Adults and Children

Resource links provided by NLM:

MedlinePlus related topics: Malaria
U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Parasite reduction [ Time Frame: 3 initial days (72h) ] [ Designated as safety issue: No ]
  • Safety assessment [ Time Frame: 28 days post 1st study drug administration ] [ Designated as safety issue: Yes ]

Enrollment: 113
Study Start Date: August 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   6 Months to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00739206

Locations
Benin
Sanofi-Aventis Administrative Office
Porto Novo, Benin
Burkina Faso
Sanofi-Aventis Administrative Office
Ouagadougou, Burkina Faso
Gabon
Sanofi-Aventis Administrative Office
Libreville, Gabon
Tanzania
Sanofi-Aventis Administrative Office
Dodoma, Tanzania
Sponsors and Collaborators
Sanofi
Investigators
Study Director: ICD CSD Sanofi
  More Information

No publications provided

Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00739206     History of Changes
Other Study ID Numbers: ACT10004
Study First Received: August 20, 2008
Last Updated: June 15, 2010
Health Authority: Gabon: Ministry of Health

Keywords provided by Sanofi:
uncomplicated
severe
treatment
Plasmodium Falciparum

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases

ClinicalTrials.gov processed this record on May 16, 2013