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

Primary Purpose

Malaria

Status

Terminated

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

SAR97276A

arthemeter + lumefantrine (ACTs)

About this trial

This is an interventional treatment trial for Malaria

Eligibility Criteria

2 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Investigational Site Number 204001
Investigational Site Number 854001
Investigational Site Number 266001
Investigational Site Number 404001

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Experimental

Arm Label

Step 1 (SAR97276A od)

Step 1 (SAR97276A bid)

Step 1 (ACTs)

Step 2 (SAR97276A)

Step 2 (ACTs)

Step 3 (SAR97276A)

Arm Description

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

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

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

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)

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

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)

Outcomes

Primary Outcome Measures

Parasite Reduction Ratio (PRR)

Secondary Outcome Measures

Evolution of mean Parasitaemia over time (nb/µL)

Evolution of mean Gametocytes count over time (nb/µL)

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

General conditions improvement: mean total symptom score over time

SAR97276 pharmacokinetic profile in plasma and blood

Full Information

NCT ID

NCT01445938

First Posted

September 26, 2011

Last Updated

December 12, 2012

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT01445938

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2012

Overall Recruitment Status

Terminated

Why Stopped

Data Monitoring Committee recommendation

Study Start Date

October 2011 (undefined)

Primary Completion Date

January 2012 (Actual)

Study Completion Date

January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

Detailed 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malaria

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Step 1 (SAR97276A od)

Arm Type

Experimental

Arm Description

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

Arm Title

Step 1 (SAR97276A bid)

Arm Type

Experimental

Arm Description

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

Arm Title

Step 1 (ACTs)

Arm Type

Active Comparator

Arm Description

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

Arm Title

Step 2 (SAR97276A)

Arm Type

Experimental

Arm Description

Arm Title

Step 2 (ACTs)

Arm Type

Active Comparator

Arm Description

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

Arm Title

Step 3 (SAR97276A)

Arm Type

Experimental

Arm Description

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 Type

Drug

Intervention Name(s)

SAR97276A

Intervention Description

Pharmaceutical form:solution for injection Route of administration: intramuscular

Intervention Type

Drug

Intervention Name(s)

arthemeter + lumefantrine (ACTs)

Intervention Description

Pharmaceutical form:tablet Route of administration: oral

Primary Outcome Measure Information:

Title

Parasite Reduction Ratio (PRR)

Time Frame

at 72 hours

Secondary Outcome Measure Information:

Title

Evolution of mean Parasitaemia over time (nb/µL)

Time Frame

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

Title

Evolution of mean Gametocytes count over time (nb/µL)

Time Frame

from baseline to end of study (day 28 ± 2)

Title

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

Time Frame

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

Title

General conditions improvement: mean total symptom score over time

Time Frame

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

Title

SAR97276 pharmacokinetic profile in plasma and blood

Time Frame

from baseline up to 12 hours after the last study drug intake on (Day 3

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Sciences & Operations

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name

Investigational Site Number 204001

City

Cotonou

Country

Benin

Facility Name

Investigational Site Number 854001

City

Ouagadougou

Country

Burkina Faso

Facility Name

Investigational Site Number 266001

City

Libreville

Country

Gabon

Facility Name

Investigational Site Number 404001

City

Kisumu

Country

Kenya

12. IPD Sharing Statement

Citations:

PubMed Identifier

28472957

Citation

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.

Results Reference

derived

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

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