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In accordance with protocol's predefined criteria and Data Monitoring Committee recommendation due to insufficient level of efficacy
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Adult patients with uncomplicated malaria |
|
| Cohort 2 | Experimental | Pediatric patients with uncomplicated malaria |
|
| Cohort 3 | Experimental | Pediatric patients with severe malaria |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SAR97276A | Drug | Dose based on body weight |
|
| Measure | Description | Time Frame |
|---|---|---|
| Combination of fever clearance, general condition improvement at 48h parasite reduction at 72h and no need for rescue therapy at 72h | 3 initial days |
| Measure | Description | Time Frame |
|---|---|---|
| Parasite reduction | 3 initial days (72h) | |
| Safety assessment | 28 days post 1st study drug administration |
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Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| ICD CSD | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis Administrative Office | Porto-Novo | Benin | ||||
| Sanofi-Aventis Administrative Office |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28472957 | Derived | 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. |
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| ID | Term |
|---|---|
| D008288 | Malaria |
| D008224 | Lymphoma, Follicular |
| D016778 | Malaria, Falciparum |
| ID | Term |
|---|---|
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
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| Ouagadougou |
| Burkina Faso |
| Sanofi-Aventis Administrative Office | Libreville | Gabon |
| Sanofi-Aventis Administrative Office | Dodoma | Tanzania |
| D000079426 |
| Vector Borne Diseases |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |