Anti-parasitic Activity and Safety Assessment of SAR97276A in Children With Uncomplicated Malaria

Phase 2

Terminated

• Conditions: Malaria
• Interventions: Drug: arthemeter + lumefantrine (ACTs); Drug: SAR97276A

• Registration Number: NCT01445938
• Lead Sponsor: Sanofi

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 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

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

Study Timeline

• Study First Submitted: 2011-09-26
• Study First Submitted QC: 2011-09-30
• Study Start: 2011-10
• Study First Posted: 2011-10-04
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-12
• Last Update Posted: 2012-12-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Step 2 (ACTs)	arthemeter + lumefantrine (ACTs)	1 group of paediatric patients will receive arthemeter + lumefantrine (ACTs) bid for 3 days
Step 1 (SAR97276A bid)	SAR97276A	1 group of paediatric patients will receive 0.25 mg/kg SAR97276A administration twice daily (bid) for 3 days
Step 1 (SAR97276A od)	SAR97276A	1 group of paediatric patients will receive 0.5 mg/kg SAR97276A administration once daily (od) for 3 days
Step 1 (ACTs)	arthemeter + lumefantrine (ACTs)	1 group of paediatric patients will receive arthemeter + lumefantrine (ACTs) bid for 3 days
Step 3 (SAR97276A)	SAR97276A	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)
Step 2 (SAR97276A)	SAR97276A	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)

Primary Outcome Measures

Name	Time	Method
Parasite Reduction Ratio (PRR)	at 72 hours

Secondary Outcome Measures

Name	Time	Method
General conditions improvement: mean total symptom score over time	every 6 hours from baseline up to 72 hours (day 4)
SAR97276 pharmacokinetic profile in plasma and blood	from baseline up to 12 hours after the last study drug intake on (Day 3
Evolution of mean Parasitaemia over time (nb/µL)	every 6 hours from baseline up to 72 hours (day 4)
Fever Clearance (time to reach Temperature < 38°C)	every 6 hours from baseline up to 72 hours (day 4)
Evolution of mean Gametocytes count over time (nb/µL)	from baseline to end of study (day 28 ± 2)

Trial Locations

Locations (4)

Investigational Site Number 204001; 🇧🇯 Cotonou, Benin

Investigational Site Number 266001; 🇬🇦 Libreville, Gabon

Investigational Site Number 404001; 🇰🇪 Kisumu, Kenya

Investigational Site Number 854001; 🇧🇫 Ouagadougou, Burkina Faso