Clinical trial NCT00739206: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Malaria
Keywords: uncomplicated
severe
treatment
Plasmodium Falciparum
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-08-21
Enrollment: 113
Sex: ALL
Minimum age (years): 6
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Combination of fever clearance, general condition improvement at 48h parasite reduction at 72h and no need for rescue therapy at 72h
timeFrame: 3 initial days
Secondary outcomes:
measure: Parasite reduction
timeFrame: 3 initial days (72h)
measure: Safety assessment
timeFrame: 28 days post 1st study drug administration
Other outcomes:
Locations:
city: Porto Novo
country: Benin
facility: Sanofi-Aventis Administrative Office
city: Ouagadougou
country: Burkina Faso
facility: Sanofi-Aventis Administrative Office
city: Libreville
country: Gabon
facility: Sanofi-Aventis Administrative Office
city: Dodoma
country: Tanzania
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: ICD CSD
role: STUDY_DIRECTOR
References:
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.