Clinical trial · Interventional
Study of SAR97276A in the Treatment of Uncomplicated and Severe Malaria in Adults and Children.
A Multicenter, Open Label, Efficacy and Safety Study of Parenteral SAR97276A in the Treatment of Symptomatic Uncomplicated and Severe Malaria in Adults and Children
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): In accordance with protocol's predefined criteria and Data Monitoring Committee recommendation due to insufficient level of efficacy
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malaria | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SAR97276A | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Cohort 1
- description
- Adult patients with uncomplicated malaria
- interventionNames
- Drug: SAR97276A
- type
- EXPERIMENTAL
- label
- Cohort 2
- description
- Pediatric patients with uncomplicated malaria
- interventionNames
- Drug: SAR97276A
- type
- EXPERIMENTAL
- label
- Cohort 3
- description
- Pediatric patients with severe malaria
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Months
- Maximum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDHeld 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