NCT01445938

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

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2011

Shorter than P25 for phase_2

Geographic Reach
4 countries

4 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2011

Completed
5 days until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 4, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

December 13, 2012

Status Verified

December 1, 2012

Enrollment Period

3 months

First QC Date

September 26, 2011

Last Update Submit

December 12, 2012

Conditions

Malaria

Outcome Measures

Primary Outcomes (1)

  • Parasite Reduction Ratio (PRR)

    at 72 hours

Secondary Outcomes (5)

  • Evolution of mean Parasitaemia over time (nb/µL)

    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)

  • Fever Clearance (time to reach Temperature < 38°C)

    every 6 hours from baseline up to 72 hours (day 4)

  • 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

Study Arms (6)

Step 1 (SAR97276A od)

EXPERIMENTAL

1 group of paediatric patients will receive 0.5 mg/kg SAR97276A administration once daily (od) for 3 days

Drug: SAR97276A

Step 1 (SAR97276A bid)

EXPERIMENTAL

1 group of paediatric patients will receive 0.25 mg/kg SAR97276A administration twice daily (bid) for 3 days

Drug: SAR97276A

Step 1 (ACTs)

ACTIVE COMPARATOR

1 group of paediatric patients will receive arthemeter + lumefantrine (ACTs) bid for 3 days

Drug: arthemeter + lumefantrine (ACTs)

Step 2 (SAR97276A)

EXPERIMENTAL

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)

Drug: SAR97276A

Step 2 (ACTs)

ACTIVE COMPARATOR

1 group of paediatric patients will receive arthemeter + lumefantrine (ACTs) bid for 3 days

Drug: arthemeter + lumefantrine (ACTs)

Step 3 (SAR97276A)

EXPERIMENTAL

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)

Drug: SAR97276A

Interventions

SAR97276ADRUG

Pharmaceutical form:solution for injection Route of administration: intramuscular

Step 1 (SAR97276A bid)Step 1 (SAR97276A od)Step 2 (SAR97276A)Step 3 (SAR97276A)
arthemeter + lumefantrine (ACTs)DRUG

Pharmaceutical form:tablet Route of administration: oral

Step 1 (ACTs)Step 2 (ACTs)

Eligibility Criteria

Age2 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Investigational Site Number 204001

Cotonou, Benin

Location

Investigational Site Number 854001

Ouagadougou, Burkina Faso

Location

Investigational Site Number 266001

Libreville, Gabon

Location

Investigational Site Number 404001

Kisumu, Kenya

Location

Related Publications (1)

  • Held J, Supan C, Salazar CLO, Tinto H, Bonkian LN, Nahum A, Sie A, Abdulla S, Cantalloube C, Djeriou E, Bouyou-Akotet M, Ogutu B, Mordmuller B, Kreidenweiss A, Siribie M, Sirima SB, Kremsner PG. Safety and efficacy of the choline analogue SAR97276 for malaria treatment: results of two phase 2, open-label, multicenter trials in African patients. Malar J. 2017 May 4;16(1):188. doi: 10.1186/s12936-017-1832-x.

    PMID: 28472957DERIVED

MeSH Terms

Conditions

Malaria

Interventions

Lumefantrine

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Intervention Hierarchy (Ancestors)

FluorenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Clinical Sciences & Operations

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2011

First Posted

October 4, 2011

Study Start

October 1, 2011

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

December 13, 2012

Record last verified: 2012-12

Locations

BE(1)GA(1)BU(1)KE(1)