Anti-parasitic Activity and Safety Assessment of SAR97276A in Children With Uncomplicated Malaria
Status and phase
Terminated
Phase 2
Conditions
Malaria
Treatments
Drug: arthemeter + lumefantrine (ACTs)
Drug: SAR97276A
Study type
Interventional
Funder types
Industry
Identifiers
Details and patient eligibility
About
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 Objectives:
- To assess the evolution of clinical signs and symptoms (including the need for a rescue therapy) in pediatric patients with uncomplicated malaria receiving SAR97276A with reference to Artemisinin-Based Combination Therapy (ACTs)
- To assess the pharmacokinetics profile of SAR97276A in pediatric patients with uncomplicated malaria
- To assess the safety profile of SAR97276A in pediatric patients with uncomplicated malaria
- To assess the pharmacokinetic-pharmacodynamic relationship of SAR97276A
Full 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
Enrollment
20 patients
Sex
All
Ages
2 to 17 years old
Volunteers
No Healthy Volunteers
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.
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
None (Open label)
20 participants in 6 patient groups
Step 1 (SAR97276A od)
Experimental group
Description:
1 group of paediatric patients will receive 0.5 mg/kg SAR97276A administration once daily (od) for 3 days
Treatment:
Drug: SAR97276A
Step 1 (SAR97276A bid)
Experimental group
Description:
1 group of paediatric patients will receive 0.25 mg/kg SAR97276A administration twice daily (bid) for 3 days
Treatment:
Drug: SAR97276A
Step 1 (ACTs)
Active Comparator group
Description:
1 group of paediatric patients will receive arthemeter + lumefantrine (ACTs) bid for 3 days
Treatment:
Drug: arthemeter + lumefantrine (ACTs)
Step 2 (SAR97276A)
Experimental group
Description:
1 or 2 groups of paediatric patients will receive SAR97276A once daily (od) or twice a day (bid) administration for 3 days (the choice of the od or bid regimen will be based on the results obtained in step 1)
Treatment:
Drug: SAR97276A
Step 2 (ACTs)
Active Comparator group
Description:
1 group of paediatric patients will receive arthemeter + lumefantrine (ACTs) bid for 3 days
Treatment:
Drug: arthemeter + lumefantrine (ACTs)
Step 3 (SAR97276A)
Experimental group
Description:
1 group of paediatric patients (2 to 11 years old) will receive: SAR97276A od or bid administration for 3 days (depending on results of step 1)
Treatment:
Drug: SAR97276A
Trial contacts and locations
4
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Data sourced from clinicaltrials.gov
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