MalariaPhase 4NCT00540410
Cohort Study in Senegal Comparing Artesunate + Amiodaquine in the Treatment of Repeated Uncomplicated Plasmodium Falciparum Malaria Attacks
A Phase 4 study testing Coarsucam® (artésunate (AS) + amodiaquine (AQ) as fixed dose combination) and Coartem® (arthemether+ lumefantrine) in people with Malaria, run by Sanofi at 1 site in Senegal.
Trial summary
Primary objective: to demonstrate the non-inferiority of PCR adjusted adequate clinical and parasitological response at D28 of artesunate + amiodaquine versus artemether + lumefantrine, based on the first malaria attack of each subject. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Malaria
- What is being tested?
- Coarsucam® (artésunate (AS) + amodiaquine (AQ) as fixed dose combination) and Coartem® (arthemether+ lumefantrine)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 366 participants
- Where
- 1 siteSenegal
- Study dates
- Sep 2007to Feb 2009
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- adults or children weighting more than 5 kg
- axillary temperature >=37.5°C at D0 or history of fever within the previous 24hrs
- confirmed Plasmodium falciparum monoinfection, with parasitemia>1000mcl
- negative urinary pregnancy test for women of child bearing age before each new administration of treatment
Who cannot join
- presence of any serious or clinical danger sign of malaria: prostration, consciousness disorders, recent and repeated convulsions, respiratory distress, inability to drink, uncontrollable vomiting, macroscopic haemoglobinuria, jaundice, haemorrhagic shock, systolic BP< 70 mmHg in adults or < 50 mmHg in children, spontaneous bleeding, inability to sit or stand
- severe concomitant disease
- allergy to one of the investigational drugs.
- 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 Randomized Study to Compare Artesunate + Amiodaquine Versus Artemether + Lumefantrine in the Treatment of Repeated Uncomplicated Plasmodium Falciparum Malaria Attacks Occurring During 2 Years in a Cohort in Senegal
Primary objective: to demonstrate the non-inferiority of PCR adjusted adequate clinical and parasitological response at D28 of artesunate + amiodaquine versus artemether + lumefantrine, based on the first malaria attack of each subject.
Secondary objectives:
Read more
For the first attack: To compare the two groups of treatment in terms of:
- D14 efficacy
- Parasitological and fever clearance
- Clinical and biological tolerability
- Evolution of gametocyte carriage
- Cardiac tolerability (QTc)
For the repeated attacks: To compare the two groups of treatment in terms of:
- D14 and D28 clinical and parasitological effectiveness (PCR adjusted)
- Clinical and biological tolerability
- Proportion of patients without fever at D3
- Proportion of patients without parasite at D3
- Compliance
- Impact on anaemia
During the total follow-up of the cohort: To compare the two groups of treatment in term of:
- Treatment incidence density
- Impact of repeated treatment on clinical and biological safety
- Impact of repeated treatment on hearing capacity
- Conditions
- Malaria
- Being tested
- Coarsucam® (artésunate (AS) + amodiaquine (AQ) as fixed dose combination), Coartem® (arthemether+ lumefantrine)
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coarsucam® (artésunate (AS) + amodiaquine (AQ) as fixed dose combination)Drug
Infants tablets: AS 25/AQ 67,5 mg Toddlers tablets: AS 50/AQ 135 mg Once daily, dose according to bodyweight range Duration of treatment: 3days Children tablets: AS 100/AQ 270 mg
Coartem® (arthemether+ lumefantrine)Drug
Tablets, 20/120 mg, oral route, twice daily, dose according to bodyweight range.
Duration of treatment: 3 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Coarsucam® (artésunate (AS) + amodiaquine (AQ) as fixed dose combination) |
| 2 | Active comparator | Not described Receives: Drug: Coartem® (arthemether+ lumefantrine) |
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 D28 and for the first attack
Secondary outcomes (7)
PCR corrected and uncorrected clinical and parasitological cure rate
Measured: at D28 and for the next attacks
Fever and parasitological clearance
Measured: first attack
Proportion of afebrile patients and proportion of patients without parasites
Measured: at D3 for the following attacks
Clinical tolerability (incidence and intensity of recorded AE)
Measured: during the study period
Biological tolerability (Hb, bilirubin, ALAT, Creatinine, Leukocytes, Neutrophils and platelets count)
Measured: during the study period
Cardiac tolerability (QTc) for the first attack in patients group aged >= 12 years)
Measured: at the time of the first attack
Assessment and evolution of hearing function in patients groupe aged >=12 years
Measured: during the study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2007 (estimated)
- Study startSep 2007
- Primary completionFeb 2009
- Study completionFeb 2009
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
- 366 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
- NCT00540410
- Sponsor's protocol ID
- ARAMF_L_02873
- Status last verified
- Jun 2010
- First submitted
- 5 Oct 2007
- Last updated
- 23 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Ndiaye JL, Faye B, Gueye A, Tine R, Ndiaye D, Tchania C, Ndiaye I, Barry A, Cisse B, Lameyre V, Gaye O. Repeated treatment of recurrent uncomplicated Plasmodium falciparum malaria in Senegal with fixed-dose artesunate plus amodiaquine versus fixed-dose artemether plus lumefantrine: a randomized, open-label trial. Malar J. 2011 Aug 12;10:237. doi: 10.1186/1475-2875-10-237.
PubMed 21838909
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study to Compare Artesunate + Amiodaquine Versus Artemether + Lumefantrine in the Treatment of Repeated Uncomplicated Plasmodium Falciparum Malaria Attacks Occurring During 2 Years in a Cohort in Senegal
- ClinicalTrials.gov ID
- NCT00540410
- Acronym / sponsor ID
- ARAMF_L_02873
- Conditions
- Malaria
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 366 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 8 Oct 2007 (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 demonstrate the non-inferiority of PCR adjusted adequate clinical and parasitological response at D28 of artesunate + amiodaquine versus artemether + lumefantrine, based on the first malaria attack of each subject.
Secondary objectives:
For the first attack: To compare the two groups of treatment in terms of:
- D14 efficacy
- Parasitological and fever clearance
- Clinical and biological tolerability
- Evolution of gametocyte carriage
- Cardiac tolerability (QTc)
For the repeated attacks: To compare the two groups of treatment in terms of:
- D14 and D28 clinical and parasitological effectiveness (PCR adjusted)
- Clinical and biological tolerability
- Proportion of patients without fever at D3
- Proportion of patients without parasite at D3
- Compliance
- Impact on anaemia
During the total follow-up of the cohort: To compare the two groups of treatment in term of:
- Treatment incidence density
- Impact of repeated treatment on clinical and biological safety
- Impact of repeated treatment on hearing capacity
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: Coarsucam® (artésunate (AS) + amodiaquine (AQ) as fixed dose combination) |
| 2 | Active comparator | Drug: Coartem® (arthemether+ lumefantrine) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- adults or children weighting more than 5 kg
- axillary temperature >=37.5°C at D0 or history of fever within the previous 24hrs
- confirmed Plasmodium falciparum monoinfection, with parasitemia>1000mcl
- negative urinary pregnancy test for women of child bearing age before each new administration of treatment
Key exclusion criteria (4 listed)
- presence of any serious or clinical danger sign of malaria: prostration, consciousness disorders, recent and repeated convulsions, respiratory distress, inability to drink, uncontrollable vomiting, macroscopic haemoglobinuria, jaundice, haemorrhagic shock, systolic BP< 70 mmHg in adults or < 50 mmHg in children, spontaneous bleeding, inability to sit or stand
- severe concomitant disease
- allergy to one of the investigational drugs.
- 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 |
|---|---|---|
| Coarsucam® (artésunate (AS) + amodiaquine (AQ) as fixed dose combination)Infants tablets: AS 25/AQ 67,5 mg Toddlers tablets: AS 50/AQ 135 mg Once daily, dose according to bodyweight range Duration of treatment: 3days Children tablets: AS 100/AQ 270 mg | Drug | 1 |
| Coartem® (arthemether+ lumefantrine)Tablets, 20/120 mg, oral 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 D28 and for the first attack
7 secondary outcomes
PCR corrected and uncorrected clinical and parasitological cure rate
Time frame: at D28 and for the next attacks
Fever and parasitological clearance
Time frame: first attack
Proportion of afebrile patients and proportion of patients without parasites
Time frame: at D3 for the following attacks
Clinical tolerability (incidence and intensity of recorded AE)
Time frame: during the study period
Biological tolerability (Hb, bilirubin, ALAT, Creatinine, Leukocytes, Neutrophils and platelets count)
Time frame: during the study period
Cardiac tolerability (QTc) for the first attack in patients group aged >= 12 years)
Time frame: at the time of the first attack
Assessment and evolution of hearing function in patients groupe aged >=12 years
Time frame: during the study period
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 23 Jun 2010.
- Derived from this study: PubMed 21838909Ndiaye JL, Faye B, Gueye A, Tine R, Ndiaye D, Tchania C, Ndiaye I, Barry A, Cisse B, Lameyre V, Gaye O. Repeated treatment of recurrent uncomplicated Plasmodium falciparum malaria in Senegal with fixed-dose artesunate plus amodiaquine versus fixed-dose artemether plus lumefantrine: a randomized, open-label trial. Malar J. 2011 Aug 12;10:237. doi: 10.1186/1475-2875-10-237.
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® (artésunate (AS) + amodiaquine (AQ) as fixed dose combination) and Coartem® (arthemether+ lumefantrine) in people with Malaria, run by Sanofi at 1 site in Senegal.
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 4 inclusion and 4 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 23 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 Senegal. 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 D28 and for the first attack). 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 NCT00540410, 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 23 Jun 2010.