MalariaPhase 2NCT01445938
Anti-parasitic Activity and Safety Assessment of SAR97276A in Children With Uncomplicated Malaria
A Phase 2 study testing SAR97276A and arthemeter + lumefantrine (ACTs) in people with Malaria, run by Sanofi at 4 sites in 4 countries.
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… Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Malaria
- What is being tested?
- SAR97276A and arthemeter + lumefantrine (ACTs)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Oct 2011to Jan 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
About this study
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
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
- Malaria
- Being tested
- SAR97276A, arthemeter + lumefantrine (ACTs)
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAR97276ADrug
Pharmaceutical form:solution for injection
Route of administration: intramuscular
arthemeter + lumefantrine (ACTs)Drug
Pharmaceutical form:tablet
Route of administration: oral
| Study group | Role | What they receive |
|---|---|---|
| Step 1 (SAR97276A od) | Experimental | 1 group of paediatric patients will receive 0.5 mg/kg SAR97276A administration once daily (od) for 3 days Receives: 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 Receives: Drug: SAR97276A |
| Step 1 (ACTs) | Active comparator | 1 group of paediatric patients will receive arthemeter + lumefantrine (ACTs) bid for 3 days Receives: 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) Receives: Drug: SAR97276A |
| Step 2 (ACTs) | Active comparator | 1 group of paediatric patients will receive arthemeter + lumefantrine (ACTs) bid for 3 days Receives: 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) Receives: Drug: SAR97276A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parasite Reduction Ratio (PRR)
Measured: at 72 hours
Secondary outcomes (5)
Evolution of mean Parasitaemia over time (nb/µL)
Measured: every 6 hours from baseline up to 72 hours (day 4)
Evolution of mean Gametocytes count over time (nb/µL)
Measured: from baseline to end of study (day 28 ± 2)
Fever Clearance (time to reach Temperature < 38°C)
Measured: every 6 hours from baseline up to 72 hours (day 4)
General conditions improvement: mean total symptom score over time
Measured: every 6 hours from baseline up to 72 hours (day 4)
SAR97276 pharmacokinetic profile in plasma and blood
Measured: from baseline up to 12 hours after the last study drug intake on (Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionJan 2012
- Study completionJan 2012
Why it stopped: Data Monitoring Committee recommendation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MalariaStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01445938
- Sponsor's protocol ID
- PDY11737
- Other IDs
- 2010-021398-36, U1111-1118-0694
- Status last verified
- Dec 2012
- First submitted
- 26 Sep 2011
- Last updated
- 13 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
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
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01445938
- Acronym / sponsor ID
- PDY11737
- Conditions
- Malaria
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Data Monitoring Committee recommendation
- Enrolment
- 20 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 4 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Step 1 (SAR97276A od) | Experimental | Drug: SAR97276A1 group of paediatric patients will receive 0.5 mg/kg SAR97276A administration once daily (od) for 3 days |
| Step 1 (SAR97276A bid) | Experimental | Drug: SAR97276A1 group of paediatric patients will receive 0.25 mg/kg SAR97276A administration twice daily (bid) for 3 days |
| Step 1 (ACTs) | Active comparator | Drug: arthemeter + lumefantrine (ACTs)1 group of paediatric patients will receive arthemeter + lumefantrine (ACTs) bid for 3 days |
| Step 2 (SAR97276A) | Experimental | Drug: SAR97276A1 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) |
| Step 2 (ACTs) | Active comparator | Drug: arthemeter + lumefantrine (ACTs)1 group of paediatric patients will receive arthemeter + lumefantrine (ACTs) bid for 3 days |
| Step 3 (SAR97276A) | Experimental | Drug: SAR97276A1 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) |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SAR97276APharmaceutical form:solution for injection Route of administration: intramuscular | Drug | Step 1 (SAR97276A bid), Step 1 (SAR97276A od), Step 2 (SAR97276A), Step 3 (SAR97276A) |
| arthemeter + lumefantrine (ACTs)Pharmaceutical form:tablet Route of administration: oral | Drug | Step 1 (ACTs), Step 2 (ACTs) |
Primary outcome
Parasite Reduction Ratio (PRR)
Time frame: at 72 hours
5 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
Results and safety
The study was stopped early (reason given: Data Monitoring Committee recommendation). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2012.
- Derived from this study: PubMed 28472957Held 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SAR97276A and arthemeter + lumefantrine (ACTs) in people with Malaria, run by Sanofi at 4 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Benin, Burkina Faso, Gabon, Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Data Monitoring Committee recommendation). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parasite Reduction Ratio (PRR) (time frame: at 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01445938, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2012.