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

Primary Purpose

Malaria

Status

Terminated

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

SAR97276A

About this trial

This is an interventional treatment trial for Malaria focused on measuring uncomplicated, severe, treatment, Plasmodium Falciparum

Eligibility Criteria

6 Months - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Sanofi-Aventis Administrative Office
Sanofi-Aventis Administrative Office
Sanofi-Aventis Administrative Office
Sanofi-Aventis Administrative Office

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Cohort 1

Cohort 2

Cohort 3

Arm Description

Adult patients with uncomplicated malaria

Pediatric patients with uncomplicated malaria

Pediatric patients with severe malaria

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Parasite reduction

Safety assessment

Full Information

NCT ID

NCT00739206

First Posted

August 20, 2008

Last Updated

June 15, 2010

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT00739206

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

June 2010

Overall Recruitment Status

Terminated

Why Stopped

In accordance with protocol's predefined criteria and Data Monitoring Committee recommendation due to insufficient level of efficacy

Study Start Date

August 2008 (undefined)

Primary Completion Date

June 2009 (Actual)

Study Completion Date

June 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Sanofi

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malaria

Keywords

uncomplicated, severe, treatment, Plasmodium Falciparum

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

113 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cohort 1

Arm Type

Experimental

Arm Description

Adult patients with uncomplicated malaria

Arm Title

Cohort 2

Arm Type

Experimental

Arm Description

Pediatric patients with uncomplicated malaria

Arm Title

Cohort 3

Arm Type

Experimental

Arm Description

Pediatric patients with severe malaria

Intervention Type

Drug

Intervention Name(s)

SAR97276A

Intervention Description

Dose based on body weight

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

Parasite reduction

Time Frame

3 initial days (72h)

Title

Safety assessment

Time Frame

28 days post 1st study drug administration

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

ICD CSD

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name

Sanofi-Aventis Administrative Office

City

Porto Novo

Country

Benin

Facility Name

Sanofi-Aventis Administrative Office

City

Ouagadougou

Country

Burkina Faso

Facility Name

Sanofi-Aventis Administrative Office

City

Libreville

Country

Gabon

Facility Name

Sanofi-Aventis Administrative Office

City

Dodoma

Country

Tanzania

12. IPD Sharing Statement

Citations:

PubMed Identifier

28472957

Citation

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.

Results Reference

derived

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

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