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

Malaria Clinical Trial

Official title:

An Open-label, Randomized Multicenter Study to Investigate the Anti-parasitic Activity, Pharmacokinetic and Safety of IM SAR97276A With Oral ACTs as Positive Control in Children Presenting With Symptomatic Plasmodium Falciparum Uncomplicated Malaria

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01445938
• Other study ID #: PDY11737
• Secondary ID: 2010-021398-36U1
• Status: Terminated
• Phase: Phase 2
• First received: September 26, 2011
• Last updated: December 12, 2012
• Start date: October 2011
• Est. completion date: January 2012

Study information

• Verified date: December 2012
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Kenya: Pharmacy and Poisons Board
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 17 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malaria

Intervention

Drug:
• SAR97276A
Pharmaceutical form:solution for injection Route of administration: intramuscular
• arthemeter + lumefantrine (ACTs)
Pharmaceutical form:tablet Route of administration: oral

Locations

Country	Name	City	State
Benin	Investigational Site Number 204001	Cotonou
Burkina Faso	Investigational Site Number 854001	Ouagadougou
Gabon	Investigational Site Number 266001	Libreville
Kenya	Investigational Site Number 404001	Kisumu

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

Benin,  Burkina Faso,  Gabon,  Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parasite Reduction Ratio (PRR)		at 72 hours	No
Secondary	Evolution of mean Parasitaemia over time (nb/µL)		every 6 hours from baseline up to 72 hours (day 4)	No
Secondary	Evolution of mean Gametocytes count over time (nb/µL)		from baseline to end of study (day 28 ± 2)	No
Secondary	Fever Clearance (time to reach Temperature < 38°C)		every 6 hours from baseline up to 72 hours (day 4)	No
Secondary	General conditions improvement: mean total symptom score over time		every 6 hours from baseline up to 72 hours (day 4)	No
Secondary	SAR97276 pharmacokinetic profile in plasma and blood		from baseline up to 12 hours after the last study drug intake on (Day 3	No