MalariaPhase 2NCT00739206
Study of SAR97276A in the Treatment of Uncomplicated and Severe Malaria in Adults and Children.
A Phase 2 study testing SAR97276A in people with Malaria, run by Sanofi at 4 sites in 4 countries.
Trial summary
The objective of the study is to assess the efficacy and safety of SAR97276A in severe malaria in pediatric patients. Before treating pediatric patients with severe malaria, the efficacy and safety of SAR97276A will be first tested in adult patients, then in pediatric patients, with uncomplicated malaria. Read more about this study
- Who is it for?
- Ages 6 months to 65 years
- Conditions the study is for
- Malaria
- What is being tested?
- SAR97276A
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Aug 2008to Jun 2009
- 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 6 months to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adult patients with uncomplicated malaria will be enrolled in cohort 1
- Pediatric patients with uncomplicated malaria will be enrolled in cohort 2
- Pediatric patients with severe malaria will be enrolled in cohort 3
- Plasmodium falciparum malaria confirmed in blood smear
- Fever within the last 24 hours.
Who cannot join
- Treatment with an antimalarial agent within 72h of screening
- Severe concomitant disease
- Pregnant or breast-feeding women
- Women of child bearing potential not protected by an effective method of birth control
- 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: A Multicenter, Open Label, Efficacy and Safety Study of Parenteral SAR97276A in the Treatment of Symptomatic Uncomplicated and Severe Malaria in Adults and Children
The objective of the study is to assess the efficacy and safety of SAR97276A in severe malaria in pediatric patients. Before treating pediatric patients with severe malaria, the efficacy and safety of SAR97276A will be first tested in adult patients, then in pediatric patients, with uncomplicated malaria.
The safety and the concentration of SAR97276A in blood and plasma will be assessed in adult and pediatric patients.
Read the detailed description
The treatment will be administered by intramuscular or intravenous route depending on the cohort. The treatment will be administered as single dose or 3-day repeated dose. The patients will be hospitalized for 3 days and followed up to 28 days following study treatment.
- Conditions
- Malaria
- Being tested
- SAR97276A
- Keywords
- uncomplicated, severe, treatment, Plasmodium Falciparum
- Medical subject headings
- Malaria, Lymphoma, Follicular, Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAR97276ADrug
Dose based on body weight
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Adult patients with uncomplicated malaria Receives: Drug: SAR97276A |
| Cohort 2 | Experimental | Pediatric patients with uncomplicated malaria Receives: Drug: SAR97276A |
| Cohort 3 | Experimental | Pediatric patients with severe malaria Receives: Drug: SAR97276A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combination of fever clearance, general condition improvement at 48h parasite reduction at 72h and no need for rescue therapy at 72h
Measured: 3 initial days
Secondary outcomes (2)
Parasite reduction
Measured: 3 initial days (72h)
Safety assessment
Measured: 28 days post 1st study drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionJun 2009
- Study completionJun 2009
Why it stopped: In accordance with protocol's predefined criteria and Data Monitoring Committee recommendation due to insufficient level of efficacy
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- ICD CSD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00739206
- Sponsor's protocol ID
- ACT10004
- Status last verified
- Jun 2010
- First submitted
- 20 Aug 2008
- Last updated
- 16 Jun 2010
- 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 16 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open Label, Efficacy and Safety Study of Parenteral SAR97276A in the Treatment of Symptomatic Uncomplicated and Severe Malaria in Adults and Children
- ClinicalTrials.gov ID
- NCT00739206
- Acronym / sponsor ID
- ACT10004
- Conditions
- Malaria
- Keywords
- uncomplicated, severe, treatment, Plasmodium Falciparum
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: In accordance with protocol's predefined criteria and Data Monitoring Committee recommendation due to insufficient level of efficacy
- Enrolment
- 113 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 21 Aug 2008 (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.
The objective of the study is to assess the efficacy and safety of SAR97276A in severe malaria in pediatric patients. Before treating pediatric patients with severe malaria, the efficacy and safety of SAR97276A will be first tested in adult patients, then in pediatric patients, with uncomplicated malaria.
The safety and the concentration of SAR97276A in blood and plasma will be assessed in adult and pediatric patients.
Detailed description
The treatment will be administered by intramuscular or intravenous route depending on the cohort. The treatment will be administered as single dose or 3-day repeated dose. The patients will be hospitalized for 3 days and followed up to 28 days following study treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: SAR97276AAdult patients with uncomplicated malaria |
| Cohort 2 | Experimental | Drug: SAR97276APediatric patients with uncomplicated malaria |
| Cohort 3 | Experimental | Drug: SAR97276APediatric patients with severe malaria |
Who may qualify
- Ages
- 6 months to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients with uncomplicated malaria will be enrolled in cohort 1
- Pediatric patients with uncomplicated malaria will be enrolled in cohort 2
- Pediatric patients with severe malaria will be enrolled in cohort 3
- Plasmodium falciparum malaria confirmed in blood smear
- Fever within the last 24 hours.
Key exclusion criteria (5 listed)
- Treatment with an antimalarial agent within 72h of screening
- Severe concomitant disease
- Pregnant or breast-feeding women
- Women of child bearing potential not protected by an effective method of birth control
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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 |
|---|---|---|
| SAR97276ADose based on body weight | Drug | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
Combination of fever clearance, general condition improvement at 48h parasite reduction at 72h and no need for rescue therapy at 72h
Time frame: 3 initial days
2 secondary outcomes
Parasite reduction
Time frame: 3 initial days (72h)
Safety assessment
Time frame: 28 days post 1st study drug administration
Results and safety
The study was stopped early (reason given: In accordance with protocol's predefined criteria and Data Monitoring Committee recommendation due to insufficient level of efficacy). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2010.
- 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.
ICD CSD 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 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 5 inclusion and 5 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 16 Jun 2010. 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, Tanzania. 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: In accordance with protocol's predefined criteria and Data Monitoring Committee recommendation due to insufficient level of efficacy). 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?
Combination of fever clearance, general condition improvement at 48h parasite reduction at 72h and no need for rescue therapy at 72h (time frame: 3 initial days). 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 NCT00739206, 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 16 Jun 2010.