MalariaPhase 4NCT00452907
ACT MALI: Treatment of Malaria Based on Combination Therapies
A Phase 4 study testing Artesunate, Artesunate + Sulfadoxine-Pyrimethamine and arthemether + lumefantrine in people with Malaria, run by Sanofi at 1 site in Mali.
Trial summary
Test the hypothesis that repeated administration of Artesunate/Amiodaquine, Artesunate/Sulfadoxine-Pyrimethamine and Arthemeter-Lufemantrine for the treatment of consecutive episodes of uncomplicated malaria reduces the incidence of uncomplicated falciparum malaria and malaria attributable anemia Read more about this study
- Who is it for?
- Ages 6 months and older
- Conditions the study is for
- Malaria
- What is being tested?
- Artesunate, Artesunate + Sulfadoxine-Pyrimethamine and arthemether + lumefantrine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 780 participants
- Where
- 1 siteMali
- Study dates
- Jul 2005to Jun 2007
- 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 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Body weight > 5kg
- Residence in the investigator site area for the duration of the trial
- Axillary temperature ≥ 37,5°C at Day 0
- Confirmed Plasmodium falciparum infection,with parasitemia range from 2000 to 200000 asexual parasites /µl of blood
Who cannot join
- Danger signs or signs of severe malaria
- Other severe illnesses
- Allergy to one of the drugs
- Pregnant women
- 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: Assessment of the Public Health Benefit of Artemisinine Based Combination Therapies for Uncomplicated Malaria Treatment in Mali
Test the hypothesis that repeated administration of Artesunate/Amiodaquine, Artesunate/Sulfadoxine-Pyrimethamine and Arthemeter-Lufemantrine for the treatment of consecutive episodes of uncomplicated malaria reduces the incidence of uncomplicated falciparum malaria and malaria attributable anemia
- Conditions
- Malaria
- Being tested
- Artesunate, Artesunate + Sulfadoxine-Pyrimethamine, 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.
ArtesunateDrug
oad, per os, 3 days of treatment
Artesunate + Sulfadoxine-PyrimethamineDrug
oad, per os
arthemether + lumefantrineDrug
bid, per os. Duration of treatment: 3 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Arsucam® (AS 50mg/Aq153mg),oad, per os, 3 days of treatment Receives: Drug: Artesunate |
| 2 | Active comparator | Arsumax (AS 50mg) + Sulfadoxine-Pyrimethamine (SP=SDX 500mg/PYR 25mg), oad, per os Receives: Drug: Artesunate + Sulfadoxine-Pyrimethamine |
| 3 | Active comparator | Coartem (arthemether 20mg+ lumefantrine 120 mg), bid, per os. Duration of treatment: 3 days Receives: Drug: arthemether + lumefantrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical and parasitological cure rate
Measured: at day 28
Clinical and biological tolerability
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 posted28 Mar 2007 (estimated)
- Study startJul 2005
- Primary completionJun 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 780 participants (actual)
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
- NCT00452907
- Sponsor's protocol ID
- ARTEN_L_00848
- Status last verified
- Feb 2010
- First submitted
- 27 Mar 2007
- Last updated
- 17 Feb 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Public Health Benefit of Artemisinine Based Combination Therapies for Uncomplicated Malaria Treatment in Mali
- ClinicalTrials.gov ID
- NCT00452907
- Acronym / sponsor ID
- ARTEN_L_00848
- Conditions
- Malaria
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 780 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jul 2005
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 28 Mar 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.
Test the hypothesis that repeated administration of Artesunate/Amiodaquine, Artesunate/Sulfadoxine-Pyrimethamine and Arthemeter-Lufemantrine for the treatment of consecutive episodes of uncomplicated malaria reduces the incidence of uncomplicated falciparum malaria and malaria attributable anemia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: ArtesunateArsucam® (AS 50mg/Aq153mg),oad, per os, 3 days of treatment |
| 2 | Active comparator | Drug: Artesunate + Sulfadoxine-PyrimethamineArsumax (AS 50mg) + Sulfadoxine-Pyrimethamine (SP=SDX 500mg/PYR 25mg), oad, per os |
| 3 | Active comparator | Drug: arthemether + lumefantrineCoartem (arthemether 20mg+ lumefantrine 120 mg), bid, per os. Duration of treatment: 3 days |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Body weight > 5kg
- Residence in the investigator site area for the duration of the trial
- Axillary temperature ≥ 37,5°C at Day 0
- Confirmed Plasmodium falciparum infection,with parasitemia range from 2000 to 200000 asexual parasites /µl of blood
Key exclusion criteria (5 listed)
- Danger signs or signs of severe malaria
- Other severe illnesses
- Allergy to one of the drugs
- Pregnant women
- 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 |
|---|---|---|
| Artesunateoad, per os, 3 days of treatment | Drug | 1 |
| Artesunate + Sulfadoxine-Pyrimethamineoad, per os | Drug | 2 |
| arthemether + lumefantrinebid, per os. Duration of treatment: 3 days | Drug | 3 |
Primary outcome
Clinical and parasitological cure rate
Time frame: at day 28
Clinical and biological tolerability
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 17 Feb 2010.
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.
Valérie Lameyre 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 Artesunate, Artesunate + Sulfadoxine-Pyrimethamine and arthemether + lumefantrine in people with Malaria, run by Sanofi at 1 site in Mali.
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 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: finished, as of the sponsor's last update on 17 Feb 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 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 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?
Clinical and parasitological cure rate (time frame: at day 28). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Feb 2010.