MalariaPhase 4SMART-CURENCT00699920
Cohort Study in Uganda Comparing Artesunate + Amiodaquine (Coarsucam) Versus Artemether + Lumenfantrine (Coartem) in the Treatment of Repeated Uncomplicated Plasmodium Falciparum Malaria Attacks
A Phase 4 study testing Coarsucam and Coartem in people with Malaria, run by Sanofi at 1 site in Uganda.
Trial summary
Primary objective is to demonstrate the non-inferiority of PCR (Polymerase Chain Reaction) adjusted adequate clinical and parasitological response at Day 28 of Coarsucam versus Coartem, based on the first malaria attack of each patient. Read more about this study
- Who is it for?
- Ages 6 to 59 months
- Conditions the study is for
- Malaria
- What is being tested?
- Coarsucam and Coartem
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 413 participants
- Where
- 1 siteUganda
- Study dates
- Jun 2008to Jun 2010
- Phase
- Phase 4
- 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 to 59 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Specific inclusion criteria for initial enrollment:
- Confirmed mono infection with Plasmodium falciparum, with parasite density ≥2000 asexual forms per µl of blood,
- Body weight ≥5 kg
- Able to be treated by oral route
- Fever (axillary temperatur ≥37.5 degrees Celsius) at D0 or history of fever within the previous 24 hours
- Confirmed Plasmodium falciparum infection with positive paratesimia
- Haemoglobin value ≥5.0 g/dl
Who cannot join
- Specific exclusion criteria for initial enrollment:
- Patient participating in another ongoing clinical trial
- Allergy to one of the investigational medicinal products
- History of hepatic and (or) haematological impairment during treatment with amodiaquine
- History of cardiac disease
- Concomitant febrile illness
Show all 13Show fewer
- Presence of at least one danger sign of malaria: recent history of convulsions (1-2 within 24h), unconsciousness state, lethargy, unable to drink or breast feed, vomiting everything, unable to stand/sit due to weakness
- Severe concomitant disease or known disturbances of electrolyte balance such as hypokalaemia or hypomagnesaemia
- Intake of medication metabolized by cytochrome CYP 2D6 (e.g. metoprolol, flecainide, imipramine, amitriptyline, clomipramine) at the time of inclusion
- Intake of drugs known to inhibit CYP 2A6 (e.g. methoxsalem, pilocarpine, tranylcypromine) and/or 2C8 cytochromes (e.g. trimethoprim, ritonavir, ketoconazole, montelukast, gemfibrozil) at the time of inclusion
- Intake of medication known to prolong the QTc interval, such as class IA and III antiarrythmics, neuroleptics, antidepressant agents, certain antibiotics including drugs in the macrolide class, fluoroquinolones, imidazole and triazole, antifungal agents, certain non-sedative anthistamines (terfenadine, astemizole) and cisapride at the time of inclusion
- Patient having received artesunate + amiodaquine or artemether + lumefantrine at suitable dosage within the previous 2 weeks.
- 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
1 site in 1 country.
About this study
Official title: A Randomised Study to Compare a Fixed Dose Combination of Artesunate Plus Amiodaquine (Coarsucam) Versus a Fixed Dose Combination of Artemether Plus Lumefantrine (Coartem) in the Treatment of Repeated Uncomplicated Plasmodium Falciparum Malaria Attacks Occurring During the 2 Years of Follow-up, in Children in Uganda.
Primary objective is to demonstrate the non-inferiority of PCR (Polymerase Chain Reaction) adjusted adequate clinical and parasitological response at Day 28 of Coarsucam versus Coartem, based on the first malaria attack of each patient.
Secondary objectives:
Read more
For the first attack:
To compare the 2 groups of treatment in terms of:
- Day 42 efficacy
- Parasitological and fever clearance
- Clinical and Biological tolerability
- Evolution of gametocyte carriage
For attack 2nd and following:
To compare the 2 groups of treatment in terms of:
- Day 28 and Day 42 clinical and parasitological effectiveness
- Clinical and Biological tolerability
- Proportion of patients without fever at Day 3
- Proportion of patients without parasites at Day 3
- Evolution of gametocyte carriage
- Compliance
During the total follow up of the cohort:
To compare the 2 groups of treatment in terms of:
- Treatment incidence density
- Impact of repeated treatment on clinical and biological tolerability
- Impact on anaemia
- Impact on Hackett score.
- Conditions
- Malaria
- Being tested
- Coarsucam, Coartem
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoarsucamDrug
Oral route, once daily, dose according to bodyweight range Duration of treatment: 3 days
CoartemDrug
Oral route, twice daily, dose according to bodyweight range Duration of treatment: 3 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Coarsucam double-layer artesunate/amiodaquine tablets Receives: Drug: Coarsucam |
| 2 | Active comparator | Coartem (artemether/lumefantrine) fixed-dose combination tablets Receives: Drug: Coartem |
What is being measured
The primary outcome is the main question the study is designed to answer.
PCR corrected and uncorrected clinical and parasitological cure rate
Measured: At Day 28
Secondary outcomes (9)
Fever and parasitological clearance evaluation by measuring the axillary temperature and monitoring paratesimia
Measured: At the first attack
Proportion of afebrile patients and proportion of patients without parasites
Measured: At Day 3 (following attacks)
Evolution of baseline symptoms (Clinical efficacy measure)
Measured: During the study conduct
Number of residual tablets in blisters (compliance)
Measured: At the end of the study treatment
Treatment incidence density: comparison of the number of malaria attacks between the 2 arms
Measured: During the 2 years of follow-up
Mean delay between 2 attacks
Measured: during the 2 years of follow-up
Incidence and intensity of recorded AE
Measured: from the informed consent signed up to the end of the study
Biological tolerability (Hb, Bilirubin, ALAT, Creatinine, Leucocytes, Neutrophils and Platelets count)
Measured: During the study conduct
PCR corrected and uncorrected clinical and parasitological cure rate
Measured: At Day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionJun 2010
- Study completionJun 2010
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 413 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Valerie Lemeyre, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00699920
- Sponsor's protocol ID
- ARAMF_L_02661
- Acronym
- SMART-CURE
- Status last verified
- Jun 2010
- First submitted
- 16 Jun 2008
- Last updated
- 29 Jun 2010
- Results posted
- No
Publications
Yeka A, Lameyre V, Afizi K, Fredrick M, Lukwago R, Kamya MR, Talisuna AO. Efficacy and safety of fixed-dose artesunate-amodiaquine vs. artemether-lumefantrine for repeated treatment of uncomplicated malaria in Ugandan children. PLoS One. 2014 Dec 1;9(12):e113311. doi: 10.1371/journal.pone.0113311. eCollection 2014.
PubMed 25436614
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Study to Compare a Fixed Dose Combination of Artesunate Plus Amiodaquine (Coarsucam) Versus a Fixed Dose Combination of Artemether Plus Lumefantrine (Coartem) in the Treatment of Repeated Uncomplicated Plasmodium Falciparum Malaria Attacks Occurring During the 2 Years of Follow-up, in Children in Uganda.
- ClinicalTrials.gov ID
- NCT00699920
- Acronym / sponsor ID
- SMART-CURE / ARAMF_L_02661
- Conditions
- Malaria
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 413 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 18 Jun 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.
Primary objective is to demonstrate the non-inferiority of PCR (Polymerase Chain Reaction) adjusted adequate clinical and parasitological response at Day 28 of Coarsucam versus Coartem, based on the first malaria attack of each patient.
Secondary objectives:
For the first attack:
To compare the 2 groups of treatment in terms of:
- Day 42 efficacy
- Parasitological and fever clearance
- Clinical and Biological tolerability
- Evolution of gametocyte carriage
For attack 2nd and following:
To compare the 2 groups of treatment in terms of:
- Day 28 and Day 42 clinical and parasitological effectiveness
- Clinical and Biological tolerability
- Proportion of patients without fever at Day 3
- Proportion of patients without parasites at Day 3
- Evolution of gametocyte carriage
- Compliance
During the total follow up of the cohort:
To compare the 2 groups of treatment in terms of:
- Treatment incidence density
- Impact of repeated treatment on clinical and biological tolerability
- Impact on anaemia
- Impact on Hackett score.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: CoarsucamCoarsucam double-layer artesunate/amiodaquine tablets |
| 2 | Active comparator | Drug: CoartemCoartem (artemether/lumefantrine) fixed-dose combination tablets |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Confirmed mono infection with Plasmodium falciparum, with parasite density ≥2000 asexual forms per µl of blood,
- Body weight ≥5 kg
- Able to be treated by oral route
- Fever (axillary temperatur ≥37.5 degrees Celsius) at D0 or history of fever within the previous 24 hours
- Confirmed Plasmodium falciparum infection with positive paratesimia
Key exclusion criteria (13 listed)
- Patient participating in another ongoing clinical trial
- Allergy to one of the investigational medicinal products
- History of hepatic and (or) haematological impairment during treatment with amodiaquine
- History of cardiac disease
- Concomitant febrile illness
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 |
|---|---|---|
| CoarsucamOral route, once daily, dose according to bodyweight range Duration of treatment: 3 days | Drug | 1 |
| CoartemOral route, twice daily, dose according to bodyweight range Duration of treatment: 3 days | Drug | 2 |
Primary outcome
PCR corrected and uncorrected clinical and parasitological cure rate
Time frame: At Day 28
9 secondary outcomes
Fever and parasitological clearance evaluation by measuring the axillary temperature and monitoring paratesimia
Time frame: At the first attack
Proportion of afebrile patients and proportion of patients without parasites
Time frame: At Day 3 (following attacks)
Evolution of baseline symptoms (Clinical efficacy measure)
Time frame: During the study conduct
Number of residual tablets in blisters (compliance)
Time frame: At the end of the study treatment
Treatment incidence density: comparison of the number of malaria attacks between the 2 arms
Time frame: During the 2 years of follow-up
Mean delay between 2 attacks
Time frame: during the 2 years of follow-up
Incidence and intensity of recorded AE
Time frame: from the informed consent signed up to the end of the study
Biological tolerability (Hb, Bilirubin, ALAT, Creatinine, Leucocytes, Neutrophils and Platelets count)
Time frame: During the study conduct
PCR corrected and uncorrected clinical and parasitological cure rate
Time frame: At Day 42
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2010.
- Derived from this study: PubMed 25436614Yeka A, Lameyre V, Afizi K, Fredrick M, Lukwago R, Kamya MR, Talisuna AO. Efficacy and safety of fixed-dose artesunate-amodiaquine vs. artemether-lumefantrine for repeated treatment of uncomplicated malaria in Ugandan children. PLoS One. 2014 Dec 1;9(12):e113311. doi: 10.1371/journal.pone.0113311. eCollection 2014.
Related trials for Malaria
Active, not recruitingObservational study
Trajectories and Mechanisms of Recovery From Malaria: An Observational Study
Malaria
Not yet recruiting
Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Healthy Volunteer, Malaria
Recruiting
The Effects of Iron Treatment on Vaccine Immunogenicity in Kenyan Infants With Iron Deficiency
Iron Deficiencies
RecruitingObservational study
Host and Parasite Factors That Influence Susceptibility to Malaria Infection and Disease During Pregnancy and Early Childhood in Ouelessebougou and Bamako, Mali
Malaria
RecruitingPhase 1
Safety, Tolerability and Efficacy of PfSPZ-LARC2 Vaccine Against CHMI in Malaria-Naïve Adults
Malaria Falciparum
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.
Valerie Lemeyre study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Coarsucam and Coartem in people with Malaria, run by Sanofi at 1 site in Uganda.
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 7 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: finished, as of the sponsor's last update on 29 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 1 site in Uganda. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
PCR corrected and uncorrected clinical and parasitological cure rate (time frame: At Day 28). 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 NCT00699920, 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 29 Jun 2010.