Plasmodium Falciparum InfectionPhase 2FARMNCT00988507
Dose Ranging Study of Ferroquine With Artesunate in African Adults and Children With Uncomplicated Plasmodium Falciparum Malaria
A Phase 2 study testing Ferroquine (SSR97193) and artesunate in people with Plasmodium Falciparum Infection, run by Sanofi at 10 sites in 6 countries.
Trial summary
Primary objective: To assess the Day 28 efficacy defined as the percentage of patients with no parasitic recrudescence, of 3 treatment groups - 3 dose levels of ferroquine associated with artesunate - for a 3-day treatment. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Plasmodium Falciparum Infection
- What is being tested?
- Ferroquine (SSR97193) and artesunate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 440 participants
- Where
- 10 sitesin 6 countries
- Study dates
- Oct 2009to Nov 2010
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 3 cohorts enrolled in sequence with data interim review by Data Monitoring Committee (DMC) between cohort 1-2 and cohort 2-3
- Cohort 1 : Adults > 50 kg or Adolescents >30 kg and age > or = 14 years
- Cohort 2 : Children with body weight [30 kg- 15 kg[
- Cohort 3 : Children with body weight [15 kg-10 kg]
- Age related Body Mass Index (BMI)> or = 5 th percentile.
- Presence of body temperature > or = 37.5°C or history of fever in the last 24 hours.
- Monoinfection with Plasmodium falciparum with parasitemia from 1,000/microL to 200,000/microL.
- Signed Informed Consent Form by the patient (if the patient is > or = age defining majority) or by the parents or legal guardian of minor patients (<18 years of age or < other age locally defining majority). In addition, participants with capacity for writing will sign off on an Assent Form. Patients with no capacity for writing will have the Assent Form read. In that case, an impartial witness will certify the document was read to the child.
Who cannot join
- Presence of HBs antigen and of anti-HCV antibodies
- Laboratory parameters with clinical significant abnormalities and/or reaching critical values : Hemoglobin (< 7g/dl), hematocrit, red blood cell count, white blood cell, reticulocytes, platelets, glucose, creatinine, aspartate transferase (AST), alanine transferase (ALT > 3 ULN), alkaline phosphatase, total bilirubine > 1.5 ULN.
- History or presence of any clinically significant disease or symptoms which might confound the interpretation of the safety and efficacy information.
- Splenectomized patients.
- Presence of criteria for complicated malaria
- Patients unable to drink
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- Breastfeeding patients.
- Permanent vomiting.
- Female participants with child bearing potential not willing to use an effective contraceptive(s) method(s) for the duration of the study (e.g. implants, oral contraceptives, some intra-uterine devices or a double barrier method). The need for an efficient method will be reminded to the patient and the patient's legal guardian(s) by the investigator.
- Previous treatment within 5 times the elimination half-life or within the last 14 days, whichever the longest :
- with any anti-malaria agents i.e., quinine, chloroquine, amodiaquine, mefloquine, halofantrine, sufladoxine-pyrimethamine, doxycycline-pyrimethamine, primaquine, artemether, atovaquone, proguanil, lumefantrine,
- with an other investigational drug
- with 2D6 main substrates
- Past or concomitant participation in a study with an anti-malaria vaccine.
- Measles vaccine injection within the last 15 days.
Trial locations and contacts
10 sites in 6 countries.
10 sites in 6 countries
Burkina Faso3 sites
Sanofi-Aventis Investigational Site Number 854002
Bobo-Dioulasso
Sanofi-Aventis Investigational Site Number 854003
Nouna
Sanofi-Aventis Investigational Site Number 854001
Ouagadougou
Gabon2 sites
Sanofi-Aventis Investigational Site Number 266001
B.P. 118 Lambarene
Sanofi-Aventis Investigational Site Number 266002
Libreville
Kenya2 sites
Sanofi-Aventis Investigational Site Number 404001
Kilifi
Sanofi-Aventis Investigational Site Number 404002
Kisumu
About this study
Official title: Parallel Group, Double-blind, Randomized Study Assessing the Efficacy, Safety and Pharmacokinetic Profiles of Ferroquine Associated With Artesunate and a Single-blind Dose Level of Ferroquine Alone in a 3-day Treatment of Uncomplicated Malaria Due to Plasmodium Falciparum in an Immune Symptomatic African Adult and Pediatric Population.
Primary objective: To assess the Day 28 efficacy defined as the percentage of patients with no parasitic recrudescence, of 3 treatment groups - 3 dose levels of ferroquine associated with artesunate - for a 3-day treatment.
Secondary objectives:
- To assess the efficacy of ferroquine at one dose level alone for a 3-day treatment.
- To assess the clinical safety of 4 treatment groups - 3 dose levels of ferroquine associated with artesunate and one dose level of ferroquine alone.
- To assess pharmacokinetics parameters of ferroquine and its metabolites along sparse sampling schedules.
Read the detailed description
The overall study duration is 64 days, consisting of a screening period (less or equal 1 day), of a 3-day treatment period during which the patient is hospitalized for a maximum of 60 hours, and a follow-up period of 61 days.
- Conditions
- Plasmodium Falciparum Infection
- Being tested
- Ferroquine (SSR97193), Placebo, artesunate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferroquine (SSR97193)Drug
Pharmaceutical form: capsule
Route of administration: oral
PlaceboDrug
Pharmaceutical form: capsule
Route of administration: oral
artesunateDrug
Pharmaceutical form: tablets
Route of administration: oral
| Study group | Role | What they receive |
|---|---|---|
| Ferroquine high dose + artesunate | Experimental | Ferroquine at 6 mg/kg/d OD and artesunate 4mg/kg/d OD for 3 days + ferroquine placebo capsules to maintain the blind between treatment groups. Receives: Drug: Ferroquine (SSR97193); Drug: Placebo; Drug: artesunate |
| Ferroquine medium dose + artesunate | Experimental | Ferroquine at 4 mg/kg/d OD and artesunate 4mg/kg/d OD for 3 days + ferroquine placebo capsules to maintain the blind between treatment groups. Receives: Drug: Ferroquine (SSR97193); Drug: Placebo; Drug: artesunate |
| Ferroquine low dose + artesunate | Experimental | Ferroquine at 2 mg/kg/d OD and artesunate 4mg/kg/d OD for 3 days + ferroquine placebo capsules to maintain the blind between treatment groups. Receives: Drug: Ferroquine (SSR97193); Drug: Placebo; Drug: artesunate |
| Ferroquine alone at medium dose | Experimental | Ferroquine at 4 mg/kg/d OD alone for 3 days + ferroquine placebo capsules to maintain the blind between treatment groups. Receives: Drug: Ferroquine (SSR97193); Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recrudescent infections at D28 in the groups with ferroquine associated with artesunate. Recrudescence is defined as the recurrence of the same original strain of Plasmodium falciparum regardless of clinical symptoms
Measured: 4 weeks
Secondary outcomes (6)
Cure rate at Day 28
Measured: 4 weeks
Parasite Clearance Time (Median).
Measured: up to 63 days
Fever Clearance Time (Median)
Measured: up to 63 days
Recrudescent infections at Day 28 in the ferroquine group in monotherapy
Measured: 4 weeks
Recrudescent infections at Day 63
Measured: 9 weeks
Adequate Clinical and Parasitological Response (ACPR) at D28
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionNov 2010
- Study completionNov 2010
Why it stopped: Company decision to modify the ferroquine development strategy; discontinuation not due to safety or activity unexpected findings
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 Plasmodium Falciparum InfectionStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00988507
- Sponsor's protocol ID
- DRI10382
- Acronym
- FARM
- Status last verified
- Jun 2011
- First submitted
- 1 Oct 2009
- Last updated
- 28 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Held J, Supan C, Salazar CL, Tinto H, Bonkian LN, Nahum A, Moulero B, Sie A, Coulibaly B, Sirima SB, Siribie M, Otsyula N, Otieno L, Abdallah AM, Kimutai R, Bouyou-Akotet M, Kombila M, Koiwai K, Cantalloube C, Din-Bell C, Djeriou E, Waitumbi J, Mordmuller B, Ter-Minassian D, Lell B, Kremsner PG. Ferroquine and artesunate in African adults and children with Plasmodium falciparum malaria: a phase 2, multicentre, randomised, double-blind, dose-ranging, non-inferiority study. Lancet Infect Dis. 2015 Dec;15(12):1409-19. doi: 10.1016/S1473-3099(15)00079-1. Epub 2015 Sep 3.
PubMed 26342427
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parallel Group, Double-blind, Randomized Study Assessing the Efficacy, Safety and Pharmacokinetic Profiles of Ferroquine Associated With Artesunate and a Single-blind Dose Level of Ferroquine Alone in a 3-day Treatment of Uncomplicated Malaria Due to Plasmodium Falciparum in an Immune Symptomatic African Adult and Pediatric Population.
- ClinicalTrials.gov ID
- NCT00988507
- Acronym / sponsor ID
- FARM / DRI10382
- Conditions
- Plasmodium Falciparum Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Company decision to modify the ferroquine development strategy; discontinuation not due to safety or activity unexpected findings
- Enrolment
- 440 participants (estimated)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 2 Oct 2009 (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 Day 28 efficacy defined as the percentage of patients with no parasitic recrudescence, of 3 treatment groups - 3 dose levels of ferroquine associated with artesunate - for a 3-day treatment.
Secondary objectives:
- To assess the efficacy of ferroquine at one dose level alone for a 3-day treatment.
- To assess the clinical safety of 4 treatment groups - 3 dose levels of ferroquine associated with artesunate and one dose level of ferroquine alone.
- To assess pharmacokinetics parameters of ferroquine and its metabolites along sparse sampling schedules.
Detailed description
The overall study duration is 64 days, consisting of a screening period (less or equal 1 day), of a 3-day treatment period during which the patient is hospitalized for a maximum of 60 hours, and a follow-up period of 61 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Ferroquine high dose + artesunate | Experimental | Drug: Ferroquine (SSR97193), Drug: Placebo, Drug: artesunateFerroquine at 6 mg/kg/d OD and artesunate 4mg/kg/d OD for 3 days + ferroquine placebo capsules to maintain the blind between treatment groups. |
| Ferroquine medium dose + artesunate | Experimental | Drug: Ferroquine (SSR97193), Drug: Placebo, Drug: artesunateFerroquine at 4 mg/kg/d OD and artesunate 4mg/kg/d OD for 3 days + ferroquine placebo capsules to maintain the blind between treatment groups. |
| Ferroquine low dose + artesunate | Experimental | Drug: Ferroquine (SSR97193), Drug: Placebo, Drug: artesunateFerroquine at 2 mg/kg/d OD and artesunate 4mg/kg/d OD for 3 days + ferroquine placebo capsules to maintain the blind between treatment groups. |
| Ferroquine alone at medium dose | Experimental | Drug: Ferroquine (SSR97193), Drug: PlaceboFerroquine at 4 mg/kg/d OD alone for 3 days + ferroquine placebo capsules to maintain the blind between treatment groups. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 3 cohorts enrolled in sequence with data interim review by Data Monitoring Committee (DMC) between cohort 1-2 and cohort 2-3
- Age related Body Mass Index (BMI)> or = 5 th percentile.
- Presence of body temperature > or = 37.5°C or history of fever in the last 24 hours.
- Monoinfection with Plasmodium falciparum with parasitemia from 1,000/microL to 200,000/microL.
- Signed Informed Consent Form by the patient (if the patient is > or = age defining majority) or by the parents or legal guardian of minor patients (<18 years of age or < other age locally defining majority). In addition, participants with capacity for writing will sign off on an Assent Form. Patients with no capacity for writing will have the Assent Form read. In that case, an impartial witness will certify the document was read to the child.
Key exclusion criteria (15 listed)
- Presence of HBs antigen and of anti-HCV antibodies
- Laboratory parameters with clinical significant abnormalities and/or reaching critical values : Hemoglobin (< 7g/dl), hematocrit, red blood cell count, white blood cell, reticulocytes, platelets, glucose, creatinine, aspartate transferase (AST), alanine transferase (ALT > 3 ULN), alkaline phosphatase, total bilirubine > 1.5 ULN.
- History or presence of any clinically significant disease or symptoms which might confound the interpretation of the safety and efficacy information.
- Splenectomized patients.
- Presence of criteria for complicated malaria
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 |
|---|---|---|
| Ferroquine (SSR97193)Pharmaceutical form: capsule Route of administration: oral | Drug | Ferroquine alone at medium dose, Ferroquine high dose + artesunate, Ferroquine low dose + artesunate, Ferroquine medium dose + artesunate |
| PlaceboPharmaceutical form: capsule Route of administration: oral | Drug | Ferroquine alone at medium dose, Ferroquine high dose + artesunate, Ferroquine low dose + artesunate, Ferroquine medium dose + artesunate |
| artesunatePharmaceutical form: tablets Route of administration: oral | Drug | Ferroquine high dose + artesunate, Ferroquine low dose + artesunate, Ferroquine medium dose + artesunate |
Primary outcome
Recrudescent infections at D28 in the groups with ferroquine associated with artesunate. Recrudescence is defined as the recurrence of the same original strain of Plasmodium falciparum regardless of clinical symptoms
Time frame: 4 weeks
6 secondary outcomes
Cure rate at Day 28
Time frame: 4 weeks
Parasite Clearance Time (Median).
Time frame: up to 63 days
Fever Clearance Time (Median)
Time frame: up to 63 days
Recrudescent infections at Day 28 in the ferroquine group in monotherapy
Time frame: 4 weeks
Recrudescent infections at Day 63
Time frame: 9 weeks
Adequate Clinical and Parasitological Response (ACPR) at D28
Time frame: 4 weeks
Results and safety
The study was stopped early (reason given: Company decision to modify the ferroquine development strategy; discontinuation not due to safety or activity unexpected findings). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2011.
- Derived from this study: PubMed 26342427Held J, Supan C, Salazar CL, Tinto H, Bonkian LN, Nahum A, Moulero B, Sie A, Coulibaly B, Sirima SB, Siribie M, Otsyula N, Otieno L, Abdallah AM, Kimutai R, Bouyou-Akotet M, Kombila M, Koiwai K, Cantalloube C, Din-Bell C, Djeriou E, Waitumbi J, Mordmuller B, Ter-Minassian D, Lell B, Kremsner PG. Ferroquine and artesunate in African adults and children with Plasmodium falciparum malaria: a phase 2, multicentre, randomised, double-blind, dose-ranging, non-inferiority study. Lancet Infect Dis. 2015 Dec;15(12):1409-19. doi: 10.1016/S1473-3099(15)00079-1. Epub 2015 Sep 3.
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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
10 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ferroquine (SSR97193) and artesunate in people with Plasmodium Falciparum Infection, run by Sanofi at 10 sites in 6 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 8 inclusion and 15 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 28 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Burkina Faso, Gabon, Kenya, Benin, Cameroon and 1 more country. 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: Company decision to modify the ferroquine development strategy; discontinuation not due to safety or activity unexpected findings). 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?
Recrudescent infections at D28 in the groups with ferroquine associated with artesunate. Recrudescence is defined as the recurrence of the same original strain of Plasmodium falciparum regardless of clinical symptoms (time frame: 4 weeks). 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 NCT00988507, 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 28 Jun 2011.