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

Malaria Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00739206
• Other study ID #: ACT10004
• Status: Terminated
• Phase: Phase 2
• First received: August 20, 2008
• Last updated: June 15, 2010
• Start date: August 2008
• Est. completion date: June 2009

Study information

• Verified date: June 2010
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Gabon: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 113
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 65 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malaria

Intervention

Drug:
• SAR97276A
Dose based on body weight

Locations

Country	Name	City	State
Benin	Sanofi-Aventis Administrative Office	Porto Novo
Burkina Faso	Sanofi-Aventis Administrative Office	Ouagadougou
Gabon	Sanofi-Aventis Administrative Office	Libreville
Tanzania	Sanofi-Aventis Administrative Office	Dodoma

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

Benin,  Burkina Faso,  Gabon,  Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Combination of fever clearance, general condition improvement at 48h parasite reduction at 72h and no need for rescue therapy at 72h		3 initial days	No
Secondary	Parasite reduction		3 initial days (72h)	No
Secondary	Safety assessment		28 days post 1st study drug administration	Yes