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

• Status: Terminated
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Antiparasitic Agents; Lumefantrine

Criteria

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.