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

This study has been terminated.
(Data Monitoring Committee recommendation)
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01445938
First received: September 26, 2011
Last updated: December 12, 2012
Last verified: December 2012

September 26, 2011
December 12, 2012
October 2011
January 2012   (final data collection date for primary outcome measure)
Parasite Reduction Ratio (PRR) [ Time Frame: at 72 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01445938 on ClinicalTrials.gov Archive Site
  • Evolution of mean Parasitaemia over time (nb/µL) [ Time Frame: every 6 hours from baseline up to 72 hours (day 4) ] [ Designated as safety issue: No ]
  • Evolution of mean Gametocytes count over time (nb/µL) [ Time Frame: from baseline to end of study (day 28 ± 2) ] [ Designated as safety issue: No ]
  • Fever Clearance (time to reach Temperature < 38°C) [ Time Frame: every 6 hours from baseline up to 72 hours (day 4) ] [ Designated as safety issue: No ]
  • General conditions improvement: mean total symptom score over time [ Time Frame: every 6 hours from baseline up to 72 hours (day 4) ] [ Designated as safety issue: No ]
  • SAR97276 pharmacokinetic profile in plasma and blood [ Time Frame: from baseline up to 12 hours after the last study drug intake on (Day 3 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Anti-parasitic Activity and Safety Assessment of SAR97276A in Children With Uncomplicated Malaria
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

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

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
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Malaria
  • Drug: SAR97276A

    Pharmaceutical form:solution for injection

    Route of administration: intramuscular

  • Drug: arthemeter + lumefantrine (ACTs)

    Pharmaceutical form:tablet

    Route of administration: oral

  • Experimental: Step 1 (SAR97276A od)
    1 group of paediatric patients will receive 0.5 mg/kg SAR97276A administration once daily (od) for 3 days
    Intervention: Drug: SAR97276A
  • Experimental: Step 1 (SAR97276A bid)
    1 group of paediatric patients will receive 0.25 mg/kg SAR97276A administration twice daily (bid) for 3 days
    Intervention: Drug: SAR97276A
  • Active Comparator: Step 1 (ACTs)
    1 group of paediatric patients will receive arthemeter + lumefantrine (ACTs) bid for 3 days
    Intervention: Drug: arthemeter + lumefantrine (ACTs)
  • Experimental: Step 2 (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)
    Intervention: Drug: SAR97276A
  • Active Comparator: Step 2 (ACTs)
    1 group of paediatric patients will receive arthemeter + lumefantrine (ACTs) bid for 3 days
    Intervention: Drug: arthemeter + lumefantrine (ACTs)
  • Experimental: Step 3 (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)
    Intervention: Drug: SAR97276A
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
20
January 2012
January 2012   (final data collection date for primary outcome measure)

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.

Both
2 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
Benin,   Burkina Faso,   Gabon,   Kenya
 
NCT01445938
PDY11737, 2010-021398-36, U1111-1118-0694
Yes
Sanofi
Sanofi
Not Provided
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP