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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


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
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