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

NCT00739206 | Terminated Phase 2 DMC

• 1 other identifier: ACT10004
• Study Type: interventional
• Target: 113
• Locations: 4 countries
• Sites: 4

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.

Conditions

Malaria

Keywords

uncomplicated; severe; treatment; Plasmodium Falciparum

Outcome Measures

Primary Outcomes (1)

• Combination of fever clearance, general condition improvement at 48h parasite reduction at 72h and no need for rescue therapy at 72h

  3 initial days

Secondary Outcomes (2)

• Parasite reduction

  3 initial days (72h)

• Safety assessment

  28 days post 1st study drug administration

Study Arms (3)

Cohort 1

EXPERIMENTAL

Adult patients with uncomplicated malaria

Drug: SAR97276A

Cohort 2

EXPERIMENTAL

Pediatric patients with uncomplicated malaria

Drug: SAR97276A

Cohort 3

EXPERIMENTAL

Pediatric patients with severe malaria

Drug: SAR97276A

Interventions

SAR97276A DRUG

Dose based on body weight

Cohort 1; Cohort 2; Cohort 3

Eligibility Criteria

• Age: 6 Months - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (4)

Sanofi-Aventis Administrative Office

Porto-Novo, Benin

Location

Sanofi-Aventis Administrative Office

Ouagadougou, Burkina Faso

Location

Sanofi-Aventis Administrative Office

Libreville, Gabon

Location

Sanofi-Aventis Administrative Office

Dodoma, Tanzania

Location

Related Publications (1)

• Held J, Supan C, Salazar CLO, Tinto H, Bonkian LN, Nahum A, Sie A, Abdulla S, Cantalloube C, Djeriou E, Bouyou-Akotet M, Ogutu B, Mordmuller B, Kreidenweiss A, Siribie M, Sirima SB, Kremsner PG. Safety and efficacy of the choline analogue SAR97276 for malaria treatment: results of two phase 2, open-label, multicenter trials in African patients. Malar J. 2017 May 4;16(1):188. doi: 10.1186/s12936-017-1832-x.

  PMID: 28472957 DERIVED

MeSH Terms

Conditions

Malaria; Lymphoma, Follicular; Malaria, Falciparum

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• ICD CSD

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 20, 2008
• First Posted: August 21, 2008
• Study Start: August 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: June 16, 2010

Record last verified: 2010-06

Locations

TA (1); GA (1); BU (1); BE (1)