Status:
TERMINATED
Anti-parasitic Activity and Safety Assessment of SAR97276A in Children With Uncomplicated Malaria
Lead Sponsor:
Sanofi
Conditions:
Malaria
Eligibility:
All Genders
2-17 years
Phase:
PHASE2
Brief Summary
Primary Objective: To assess the antiparasitic activity of intramuscular (IM) SAR97276A based on parasite reduction ratio at 72 hours in pediatric patients with uncomplicated malaria Secondary Objec...
Detailed Description
The total duration per patients will last approximately 28 ± 2 days broken down as follows: * A screening phase up to 12-hours * A 28 ± 2 days study period
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Patients diagnosed with symptomatic infection by Plasmodium falciparum microscopically confirmed in blood smear at Day-1 visit
- Fever (tympanic or rectal temperature ≥ 38 C) or documented history of fever within the last 24h
- Asexual parasitemia of ≥ 2 000 parasites/μL in blood smear at D-1 visit
- Signed Informed Consent Form by the parents or legal guardian
- Age: 12 to 17 years old for step 1
- Age: 2 to 11 years old for step 2 and step 3
- Exclusion criteria:
- Participation in another clinical trial within the last 3 months or participation within a different cohort in this PDY11737 clinical trial or participation to previous trial with SAR97276
- Documented history of adequate treatment with antimalarials expected to be effective within the preceding 72 hours
- Severe concomitant disease (including concomitant febrile illnesses or infection)
- Any sign suggestive of severe malaria
- Severe malnutrition
- Asexual parasitemia: Plasmodium falciparum \> 100,000 parasites/μL in blood smear at D-1 visit
- Previous treatment within 3 weeks prior to inclusion, and concomitant treatment with potent CYP3A4 inhibitors or CYP3A4 inducers or CYP2D6 substrates or potent CYP2D6 inhibitors
- Known serious adverse event reaction or hypersensitivity to Artemisinin-Based Combination Therapy (ACTs) or any contraindications from the positive control therapy (Artemisinin Combined Treatments) or warning/precaution of use as defined in the respective National Product Labeling
- Pregnant or breast-feeding women
- Women of childbearing potential not protected by effective contraceptive method of birth control, or not willing to use an effective contraceptive(s) method(s) for the duration of the study (e.g.: double barrier method), and/or who are unwilling or unable to be tested for pregnancy,
- CPK above 3 ULN,
- Underlying hepatobiliary disease or ALT\>3 ULN.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Exclusion
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01445938
Start Date
October 1 2011
End Date
January 1 2012
Last Update
December 13 2012
Active Locations (4)
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1
Investigational Site Number 204001
Cotonou, Benin
2
Investigational Site Number 854001
Ouagadougou, Burkina Faso
3
Investigational Site Number 266001
Libreville, Gabon
4
Investigational Site Number 404001
Kisumu, Kenya