TerminatedNCT01445938Updated Dec 13, 2012

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

A Phase 2 interventional study of SAR97276A and arthemeter + lumefantrine (ACTs) in Malaria, sponsored by Sanofi. Terminated at 4 sites in 4 countries. Open to participants aged 2 Years to 17 Years. Per ClinicalTrials.gov, last updated 2012-12-13.

Sponsored by Sanofi · Phase 2, Interventional, and Treatment

Why this study was terminated

Data Monitoring Committee recommendation

Phase: Phase 2
Study type: Interventional
Enrollment: 20
Allocation: Randomized
Ages: 2 Years to 17 Years
Sex: All

Study 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

Read the 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

Conditions studied

Malaria

Browse trials for

Malaria 1,298

Who can participate

Ages eligible: 2 Years to 17 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 20 participants (actual)

Study arms

Experimental
Step 1 (SAR97276A od)
1 group of paediatric patients will receive 0.5 mg/kg SAR97276A administration once daily (od) for 3 days
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
Drug: SAR97276A
Active comparator
Step 1 (ACTs)
1 group of paediatric patients will receive arthemeter + lumefantrine (ACTs) bid for 3 days
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)
Drug: SAR97276A
Active comparator
Step 2 (ACTs)
1 group of paediatric patients will receive arthemeter + lumefantrine (ACTs) bid for 3 days
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)
Drug: SAR97276A

Interventions

DrugSAR97276A
Pharmaceutical form:solution for injection Route of administration: intramuscular
Drugarthemeter + lumefantrine (ACTs)
Pharmaceutical form:tablet Route of administration: oral

What researchers measure

Primary outcomes

Parasite Reduction Ratio (PRR)
Time frame: at 72 hours

Secondary outcomes

Evolution of mean Parasitaemia over time (nb/µL)
Time frame: every 6 hours from baseline up to 72 hours (day 4)
Evolution of mean Gametocytes count over time (nb/µL)
Time frame: from baseline to end of study (day 28 ± 2)
Fever Clearance (time to reach Temperature < 38°C)
Time frame: every 6 hours from baseline up to 72 hours (day 4)
General conditions improvement: mean total symptom score over time
Time frame: every 6 hours from baseline up to 72 hours (day 4)
SAR97276 pharmacokinetic profile in plasma and blood
Time frame: from baseline up to 12 hours after the last study drug intake on (Day 3

Study locations

4 sites

Investigational Site Number 204001
Cotonou, Benin
Investigational Site Number 854001
Ouagadougou, Burkina Faso
Investigational Site Number 266001
Libreville, Gabon
Investigational Site Number 404001
Kisumu, Kenya

References and documents

Publications

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. PubMed 28472957 ↗

Registry details

Key details

Study ID: NCT01445938
Lead sponsor: Sanofi
Responsible party: Sponsor
First posted: Oct 4, 2011
Start date: Oct 2011
Primary completion: Jan 2012
Completion: Jan 2012
Last update: Dec 13, 2012

Study contacts

Clinical Sciences & Operations

study director · Sanofi

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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