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

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ClinicalTrials.gov Identifier: NCT00739206
Recruitment Status : Terminated (In accordance with protocol's predefined criteria and Data Monitoring Committee recommendation due to insufficient level of efficacy)
First Posted : August 21, 2008
Last Update Posted : June 16, 2010
Sponsor:
Information provided by:
Sanofi

Brief Summary:

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 or disease Intervention/treatment Phase
Malaria Drug: SAR97276A Phase 2

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  (Clinical Trial)
Actual Enrollment : 113 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : August 2008
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

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




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Parasite reduction [ Time Frame: 3 initial days (72h) ]
  2. Safety assessment [ Time Frame: 28 days post 1st study drug administration ]


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00739206     History of Changes
Other Study ID Numbers: ACT10004
First Posted: August 21, 2008    Key Record Dates
Last Update Posted: June 16, 2010
Last Verified: June 2010

Keywords provided by Sanofi:
uncomplicated
severe
treatment
Plasmodium Falciparum

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases