MalariaPhase 3NCT00316329
ATAQ EASY: Artesunate + Amodiaquine Fixed Dose Combination in the Treatment of Uncomplicated Plasmodium Falciparum Malaria
A Phase 3 study testing Artesunate + Amodiaquine in people with Malaria, run by Sanofi at 5 sites in 4 countries.
Trial summary
Primary Objective: To demonstrate the non-inferiority, in terms of clinical and parasitological efficacy on D28 of administration of Coarsucam™ (artesunate+amodiaquine fixed-dose combination), as a single daily dose, in comparison with administration of Coartem® (artemether+lumefantrine). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Malaria
- What is being tested?
- Artesunate + Amodiaquine
- How many people
- 1,032 participants
- Where
- 5 sitesin 4 countries
- Study dates
- Mar 2006to not given
- Phase
- Phase 3
- 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 weighing ≥ 10 kg
- residing in the zone covered by the investigating centre throughout the entire follow-up period
- capable of receiving oral treatment
- axillary temperature ≥ 37.5 degrees Celsius at the inclusion visit or history of fever within the previous 24 hours
- infection with Plasmodium falciparum, with parasite density in the blood ranging from 1000 to 200,000 asexual forms per cubic millimetre
- informed consent from each participant or parents (guardians) for the children
- negative urinary pregnancy test for all women of child-bearing age
Who cannot join
- presence of at least one 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 Blood Pressure < 70 mmHg in adults or < 50 mmHg in children, spontaneous bleeding, inability to sit or stand
- serious concomitant disease
- allergy to one of the investigational medicinal products (drug substance or excipient)
- pregnant women (reported, clinically visible or palpable pregnancy, or positive urinary pregnancy test), or breast-feeding women
- clinically documented heart disease (bradycardia, extrasystoles, exertional dyspnoea, systolic or diastolic extrasystoles, gallop rhythm…)
- history of hepatic and (or) haematological impairment during treatment with amodiaquine
Show all 12Show fewer
- intake of medication metabolised by cytochrome CYP2D6 (e.g. metoprolol, flecainide, imipramine, amitriptyline, clomipramine) or CYP3A4 (e.g. erythromycin, ketoconazole, itraconazole, cimetidine, HIV protease inhibitors)
- family history of congenital QTc prolongation or sudden death or another clinical condition known to prolong the QTc interval
- 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 antihistamines (terfenadine, astemizole) and cisapride
- certain known electrolyte imbalances such as hypokalaemia or hypomagnesaemia
- patient having received artesunate + amodiaquine or artemether + lumefantrine at a suitable dosage within 30 days prior to inclusion
- 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
5 sites in 4 countries.
5 sites in 4 countries
About this study
Official title: Multinational, Randomized, Comparative Study of the Efficacy and Safety of Three Therapeutic Regimens: Coarsucam™ (Artesunate + Amodiaquine Fixed-Dose Combination) Administered in 1 or 2 Intakes Per Day Versus Coartem® (Artemether + Lumefantrine) in the Treatment of Uncomplicated Plasmodium Falciparum Malaria
Primary Objective:
- To demonstrate the non-inferiority, in terms of clinical and parasitological efficacy on D28 of administration of Coarsucam™ (artesunate+amodiaquine fixed-dose combination), as a single daily dose, in comparison with administration of Coartem® (artemether+lumefantrine).
Secondary Objectives:
To compare the 3 treatment groups in terms of:
- clinical and parasitological efficacy on D14 and D28 on the global population and on the subpopulation consisting of children aged under 5 years and that for patients aged 5 years and over
- clinical and laboratory safety
- time to parasite clearance
- time to clearance of fever
- changes in gametocytaemia
- impact on anaemia
- Conditions
- Malaria
- Being tested
- Artesunate + Amodiaquine
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artesunate + AmodiaquineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical and parasitological cure (after PCR correction) on D28 in compliance with WHO classification, for the Coarsucam™ & Coartem® groups
Secondary outcomes (1)
Clinical & parasitological cure (after PCR correction) on D14 & D28 in the global population & in the two subpopulations-Time to clearance of parasitaemia & fever-Changes in gametocytaemia & anaemia during follow-up- Clinical & laboratory safety
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2006 (estimated)
- Study startMar 2006
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 1,032 participants
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Valérie Lameyre, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00316329
- Sponsor's protocol ID
- PM_L_0164
- Status last verified
- Apr 2008
- First submitted
- 18 Apr 2006
- Last updated
- 22 Apr 2008
- Results posted
- No
Publications
Ndiaye JL, Randrianarivelojosia M, Sagara I, Brasseur P, Ndiaye I, Faye B, Randrianasolo L, Ratsimbasoa A, Forlemu D, Moor VA, Traore A, Dicko Y, Dara N, Lameyre V, Diallo M, Djimde A, Same-Ekobo A, Gaye O. Randomized, multicentre assessment of the efficacy and safety of ASAQ--a fixed-dose artesunate-amodiaquine combination therapy in the treatment of uncomplicated Plasmodium falciparum malaria. Malar J. 2009 Jun 8;8:125. doi: 10.1186/1475-2875-8-125.
PubMed 19505304
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multinational, Randomized, Comparative Study of the Efficacy and Safety of Three Therapeutic Regimens: Coarsucam™ (Artesunate + Amodiaquine Fixed-Dose Combination) Administered in 1 or 2 Intakes Per Day Versus Coartem® (Artemether + Lumefantrine) in the Treatment of Uncomplicated Plasmodium Falciparum Malaria
- ClinicalTrials.gov ID
- NCT00316329
- Acronym / sponsor ID
- PM_L_0164
- Conditions
- Malaria
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,032 participants
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- First posted
- 20 Apr 2006 (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, in terms of clinical and parasitological efficacy on D28 of administration of Coarsucam™ (artesunate+amodiaquine fixed-dose combination), as a single daily dose, in comparison with administration of Coartem® (artemether+lumefantrine).
Secondary Objectives:
To compare the 3 treatment groups in terms of:
- clinical and parasitological efficacy on D14 and D28 on the global population and on the subpopulation consisting of children aged under 5 years and that for patients aged 5 years and over
- clinical and laboratory safety
- time to parasite clearance
- time to clearance of fever
- changes in gametocytaemia
- impact on anaemia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- adults or children weighing ≥ 10 kg
- residing in the zone covered by the investigating centre throughout the entire follow-up period
- capable of receiving oral treatment
- axillary temperature ≥ 37.5 degrees Celsius at the inclusion visit or history of fever within the previous 24 hours
- infection with Plasmodium falciparum, with parasite density in the blood ranging from 1000 to 200,000 asexual forms per cubic millimetre
Key exclusion criteria (12 listed)
- presence of at least one 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 Blood Pressure < 70 mmHg in adults or < 50 mmHg in children, spontaneous bleeding, inability to sit or stand
- serious concomitant disease
- allergy to one of the investigational medicinal products (drug substance or excipient)
- pregnant women (reported, clinically visible or palpable pregnancy, or positive urinary pregnancy test), or breast-feeding women
- clinically documented heart disease (bradycardia, extrasystoles, exertional dyspnoea, systolic or diastolic extrasystoles, gallop rhythm…)
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 |
|---|---|---|
| Artesunate + Amodiaquine | Drug | – |
Primary outcome
Clinical and parasitological cure (after PCR correction) on D28 in compliance with WHO classification, for the Coarsucam™ & Coartem® groups
1 secondary outcome
Clinical & parasitological cure (after PCR correction) on D14 & D28 in the global population & in the two subpopulations-Time to clearance of parasitaemia & fever-Changes in gametocytaemia & anaemia during follow-up- Clinical & laboratory safety
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 22 Apr 2008.
- Derived from this study: PubMed 19505304Ndiaye JL, Randrianarivelojosia M, Sagara I, Brasseur P, Ndiaye I, Faye B, Randrianasolo L, Ratsimbasoa A, Forlemu D, Moor VA, Traore A, Dicko Y, Dara N, Lameyre V, Diallo M, Djimde A, Same-Ekobo A, Gaye O. Randomized, multicentre assessment of the efficacy and safety of ASAQ--a fixed-dose artesunate-amodiaquine combination therapy in the treatment of uncomplicated Plasmodium falciparum malaria. Malar J. 2009 Jun 8;8:125. doi: 10.1186/1475-2875-8-125.
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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.
Valérie Lameyre study director
Sanofi
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Artesunate + Amodiaquine in people with Malaria, run by Sanofi at 5 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 7 inclusion and 12 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 22 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Senegal, Cameroon, Madagascar, Mali. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Clinical and parasitological cure (after PCR correction) on D28 in compliance with WHO classification, for the Coarsucam™ & Coartem® groups. 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 NCT00316329, 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 22 Apr 2008.