Study of SAR97276A in the Treatment of Uncomplicated and Severe Malaria in Adults and Children. - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00739206

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 II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
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-Aventis:

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 ]

Estimated Enrollment:	180
Study Start Date:	August 2008
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Cohort 1: Experimental Adult patients with uncomplicated malaria	Drug: SAR97276A Dose based on body weight
Cohort 2: Experimental Pediatric patients with uncomplicated malaria	Drug: SAR97276A Dose based on body weight
Cohort 3: Experimental 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-Aventis

Investigators

Study Director:

ICD CSD

Sanofi-Aventis

More Information

No publications provided

Responsible Party:	sanofi-aventis ( ICD Study Director )
Study ID Numbers:	ACT10004
Study First Received:	August 20, 2008
Last Updated:	July 24, 2009
ClinicalTrials.gov Identifier:	NCT00739206 History of Changes
Health Authority:	Gabon: Ministry of Health

Keywords provided by Sanofi-Aventis:

uncomplicated
severe
treatment
Plasmodium Falciparum

Study placed in the following topic categories:

Protozoan Infections
Parasitic Diseases
Malaria

Additional relevant MeSH terms:

Protozoan Infections
Coccidiosis
Parasitic Diseases
Malaria

ClinicalTrials.gov processed this record on September 11, 2009