Plasmodium Falciparum MalariaPhase 3NCT00484900
Multi-Centre Trial Comparing Three Artemisinin-Based Combination Treatments on P. Falciparum Malaria
A Phase 3 study testing Co-Arinate FDC and Coartem in people with Plasmodium Falciparum Malaria, run by Dafra Pharma at 4 sites in 4 countries.
Trial summary
The purpose of this open randomised multi-centre clinical trial is to test the hypothesis that three pills of the fixed dose combination artesunate/sulfamethoxypyrazine/pyrimethamine, administered over 24 hours is not inferior in efficacy to the same drug administered over 48 hours and that the fixed dose combination… Read more about this study
- Who is it for?
- Ages 6 months and older
- Conditions the study is for
- Plasmodium Falciparum Malaria
- What is being tested?
- Co-Arinate FDC and Coartem
- How many people
- 1,390 participants
- Where
- 4 sitesin 4 countries
- Study dates
- May 2006to May 2007
- 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 6 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- age at least 6 months,
- weight at least 5 kg,
- residing in one of the four countries (Mali, Cameroon, Sudan, Rwanda),
- able to receive oral treatment,
- having an axillary body temperature of more than 37,5 degrees Celsius or history of fever within the proceeding 24 hours,
- suffering from a mono specific P. falciparum infection with a parasite density between 2000 and 200000 asexual forms per micro litre of blood.
Who cannot join
- presence of severe or complicated malaria (WHO 2000),
- severe concomitant pathology or one that needs a medical follow-up incompatible with the study,
- allergic to one of the drugs involved in this study,
- pregnant (reported pregnancy, detected clinically or with the β HCG test),
- use of one of the anti-malaria drugs involved in this study during 28 days preceding inclusion.
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
About this study
Official title: Open Randomized Multi-Centre Trial, Comparing Artesunate-Sulfamethoxypyrazine-Pyrimethamine FDC Over 3 Days, Artesunate-Sulfamethoxypyrazine-Pyrimethamine FDC Over 48 Hours and Artemether-Lumefantrine FDC Over 3 Days on P. Falciparum Malaria
The purpose of this open randomised multi-centre clinical trial is to test the hypothesis that three pills of the fixed dose combination artesunate/sulfamethoxypyrazine/pyrimethamine, administered over 24 hours is not inferior in efficacy to the same drug administered over 48 hours and that the fixed dose combination artesunate/sulfamethoxypyrazine/pyrimethamine As/SMP fdc, independently of the duration of its dose interval, is not inferior in efficacy to 6 - 24 pills (number of pills administered to respectively children and adults)of the 60 hours treatment of artemether/lumefantrine for the treatment of uncomplicated P. falciparum malaria.
- Conditions
- Plasmodium Falciparum Malaria
- Being tested
- Co-Arinate FDC, Coartem
- Keywords
- Open randomized multi-centre clinical trial in Africa, Uncomplicated P. falciparum malaria, Artemisinin-based Combination Therapy, Artesunate + sulfalene + pyrimethamine, 24 hour treatment, Artemether + lumefantrine
- Medical subject headings
- Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Co-Arinate FDCDrug
CoartemDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
PCR corrected Adequate Clinical and Parasitological Response
Measured: on day 28 (follow-up period)
Early treatment failure
Measured: between day 0 and day 3
Late clinical failure
Measured: between day 4 and day 28
Late parasitological failure
Measured: between day 7 and day 28
Secondary outcomes (7)
Parasitic clearance
Measured: 28 day follow-up period
Fever clearance
Measured: 28 day follow-up period
Parasitological re-infection
Measured: 28 day follow-up period
Gametocyte carriage
Measured: 28 day follow-up period
Safety - Adverse events
Measured: 28 day follow-up period
Haemoglobin levels
Measured: 28 day follow-up period
Clinical and biological tolerance (Haemogram + Lever tests)
Measured: 28 day follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2007 (estimated)
- Study startMay 2006
- Study completionMay 2007
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 MalariaStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 1,390 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dafra Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Issaka Sagara, Dr, Principal investigator, University of Bamako, MaliWilfred F Mbacham, Dr, Principal investigator, University Yaoundé, CameroonIshag A Adam, Dr, Principal investigator, University of Khartoum, SudanStephen Rulisa, Dr, Principal investigator, Kigali Central University Hospital, Rwanda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00484900
- Sponsor's protocol ID
- 2005/57/01
- Status last verified
- Jun 2007
- First submitted
- 8 Jun 2007
- Last updated
- 26 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Sagara I, Rulisa S, Mbacham W, Adam I, Sissoko K, Maiga H, Traore OB, Dara N, Dicko YT, Dicko A, Djimde A, Jansen FH, Doumbo OK. Efficacy and safety of a fixed dose artesunate-sulphamethoxypyrazine-pyrimethamine compared to artemether-lumefantrine for the treatment of uncomplicated falciparum malaria across Africa: a randomized multi-centre trial. Malar J. 2009 Apr 14;8:63. doi: 10.1186/1475-2875-8-63.
PubMed 19366448
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Randomized Multi-Centre Trial, Comparing Artesunate-Sulfamethoxypyrazine-Pyrimethamine FDC Over 3 Days, Artesunate-Sulfamethoxypyrazine-Pyrimethamine FDC Over 48 Hours and Artemether-Lumefantrine FDC Over 3 Days on P. Falciparum Malaria
- ClinicalTrials.gov ID
- NCT00484900
- Acronym / sponsor ID
- 2005/57/01
- Conditions
- Plasmodium Falciparum Malaria
- Keywords
- Open randomized multi-centre clinical trial in Africa, Uncomplicated P. falciparum malaria, Artemisinin-based Combination Therapy, Artesunate + sulfalene + pyrimethamine, 24 hour treatment, Artemether + lumefantrine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,390 participants (actual)
- Lead sponsor
- Dafra PharmaIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Study completion
- May 2007 (actual)
- First posted
- 11 Jun 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.
The purpose of this open randomised multi-centre clinical trial is to test the hypothesis that three pills of the fixed dose combination artesunate/sulfamethoxypyrazine/pyrimethamine, administered over 24 hours is not inferior in efficacy to the same drug administered over 48 hours and that the fixed dose combination artesunate/sulfamethoxypyrazine/pyrimethamine As/SMP fdc, independently of the duration of its dose interval, is not inferior in efficacy to 6 - 24 pills (number of pills administered to respectively children and adults)of the 60 hours treatment of artemether/lumefantrine for the treatment of uncomplicated P. falciparum malaria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- age at least 6 months,
- weight at least 5 kg,
- residing in one of the four countries (Mali, Cameroon, Sudan, Rwanda),
- able to receive oral treatment,
- having an axillary body temperature of more than 37,5 degrees Celsius or history of fever within the proceeding 24 hours,
Key exclusion criteria (5 listed)
- presence of severe or complicated malaria (WHO 2000),
- severe concomitant pathology or one that needs a medical follow-up incompatible with the study,
- allergic to one of the drugs involved in this study,
- pregnant (reported pregnancy, detected clinically or with the β HCG test),
- use of one of the anti-malaria drugs involved in this study during 28 days preceding inclusion.
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 |
|---|---|---|
| Co-Arinate FDC | Drug | – |
| Coartem | Drug | – |
Primary outcome
PCR corrected Adequate Clinical and Parasitological Response
Time frame: on day 28 (follow-up period)
Early treatment failure
Time frame: between day 0 and day 3
Late clinical failure
Time frame: between day 4 and day 28
Late parasitological failure
Time frame: between day 7 and day 28
7 secondary outcomes
Parasitic clearance
Time frame: 28 day follow-up period
Fever clearance
Time frame: 28 day follow-up period
Parasitological re-infection
Time frame: 28 day follow-up period
Gametocyte carriage
Time frame: 28 day follow-up period
Safety - Adverse events
Time frame: 28 day follow-up period
Haemoglobin levels
Time frame: 28 day follow-up period
Clinical and biological tolerance (Haemogram + Lever tests)
Time frame: 28 day follow-up 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 26 Mar 2008.
- Derived from this study: PubMed 19366448Sagara I, Rulisa S, Mbacham W, Adam I, Sissoko K, Maiga H, Traore OB, Dara N, Dicko YT, Dicko A, Djimde A, Jansen FH, Doumbo OK. Efficacy and safety of a fixed dose artesunate-sulphamethoxypyrazine-pyrimethamine compared to artemether-lumefantrine for the treatment of uncomplicated falciparum malaria across Africa: a randomized multi-centre trial. Malar J. 2009 Apr 14;8:63. doi: 10.1186/1475-2875-8-63.
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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.
Issaka Sagara, Dr principal investigator
University of Bamako, Mali
Wilfred F Mbacham, Dr principal investigator
University Yaoundé, Cameroon
Ishag A Adam, Dr principal investigator
University of Khartoum, Sudan
4 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 Co-Arinate FDC and Coartem in people with Plasmodium Falciparum Malaria, run by Dafra Pharma at 4 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 6 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 26 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Cameroon, Mali, Rwanda, Sudan. 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?
PCR corrected Adequate Clinical and Parasitological Response (time frame: on day 28 (follow-up period)). The study lists 4 primary outcomes in all. 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 NCT00484900, 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 26 Mar 2008; AzTrials last refreshed its copy on 31 Oct 2026.