Uncomplicated P. Falciparum Malaria in ChildrenPhase 4ACTENCT01017770
Artemether-lumefantrine (AL) Versus Artesunate + Amodiaquine (ASAQ) for the Treatment of Uncomplicated Falciparum Malaria in Burkina Faso
A Phase 4 study testing Artesunate-amodiaquine and Artemether-lumefantrine in people with Uncomplicated P. Falciparum Malaria in Children, run by Centre Muraz at 4 sites in Burkina Faso.
Trial summary
Several countries in Africa have changed their first-line treatment for uncomplicated malaria to an ACT. Burkina Faso has changed its policy to Artemether-Lumefantrine (AL) and Artesunate-Amodiaquine (AQ+AS). Read more about this study
- Who is it for?
- Ages 6 to 59 months
- Conditions the study is for
- Uncomplicated P. Falciparum Malaria in Children
- What is being tested?
- Artesunate-amodiaquine and Artemether-lumefantrine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 340 participants
- Where
- 4 sitesBurkina Faso
- Study dates
- Sep 2008to Aug 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
- Weight > 5 kg;
- Monoinfection with P. falciparum and a parasitaemia of 2,000-200,000 parasites /µl;
- Fever (axillary temperature ≥37.5 °C) or history of fever in the preceding 24 hours;
- Haemoglobin value above 5.0 g/dl;
- Absence of febrile conditions caused by diseases other than malaria.
Who cannot join
- Danger signs: not able to drink or breast-feed, vomiting (> twice in 24hours), recent history of convulsions (>1 in 24h), unconscious state, unable to sit or stand;
- Signs of severe malaria (WHO 2000);
- Mixed malaria infection;
- Severe malnutrition;
- Other underlying diseases (cardiac, renal, hepatic diseases);
- History of allergy to study drugs;
Trial locations and contacts
4 sites in 1 country.
Burkina Faso4 sites
IRSS-DRO/Centre Muraz
Bobo-Dioulasso, Bp 545, 01
Tinto Halidou
Bobo-Dioulasso, Houet, 01
Nanoro
Nanoro, Boulkiemdé, 115
Nanoro
Nanoro, Boulkiemdé
About this study
Official title: Artemether-lumefantrine Vs Co-formulated Amodiaquine + Artesunate for the Treatment of Uncomplicated Falciparum Malaria: a Randomized Open-label Trial to Evaluate the Effectiveness of the Burkina Faso New Drug Policy
Several countries in Africa have changed their first-line treatment for uncomplicated malaria to an ACT. Burkina Faso has changed its policy to Artemether-Lumefantrine (AL) and Artesunate-Amodiaquine (AQ+AS). However, such choice has been done without knowing the local effectiveness of these drugs when they are given to patients in real life conditions, without direct observation of the drug administration. Thus, this study aims at investigating the effectiveness of AQ+AS and AL, when given to children with uncomplicated malaria in Burkina Faso.
- Being tested
- Artesunate-amodiaquine, Artemether-lumefantrine
- Keywords
- Uncomplicated malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artesunate-amodiaquineDrug
Also called ASAQ, Coarsucam
Coformulated AQ+AS by Sanofi-Aventis has been pre-qualified by WHO in 2008. It is administered once daily for three consecutive days, and it is available in three different dosages (25mg/67.5mg; 50mg/135mg; 100mg/270mg)
Artemether-lumefantrineDrug
Also called AL, Coartem(R), Riamet(R)
Artemether-lumefantrine by Novartis was the first fixed-dose ACT that was prequalified by WHO in April 2004. A 3-day, 6-dose regimen of AL is recommended for infants and children weighing 5-35 kg and adults weighing > 35 kg.
| Study group | Role | What they receive |
|---|---|---|
| Artemether -lumefantrine | Experimental | Experimental Treatment of malaria with Artemether-lumefantrine (AL), according to one of the two options given by national protocol in Burkina Faso Receives: Drug: Artemether-lumefantrine |
| Artesunate-amodiaquine | Experimental | Treatment of malaria with Artesunate-amodiaquine(AS-AQ), according to one of the two options given by national protocol in Burkina Faso Receives: Drug: Artesunate-amodiaquine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Polymerase chain reaction (PCR) adjusted treatment failure
Measured: Day 28
Secondary outcomes (3)
Treatment failure up to day 42 (PCR adjusted and unadjusted)
Measured: Day 42
Gametocytes (prevalence and density)
Measured: At day 7, 14, 21, 28, 35 and 42 days after treatment
Hb changes
Measured: Day 35
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2009 (estimated)
- Study startSep 2008
- Primary completionJan 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uncomplicated P. Falciparum Malaria in ChildrenStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 340 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Muraz
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Tropical Medicine, Belgium
- Responsible party
- Principal investigator, Tinto Halidou, Centre Muraz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01017770
- Sponsor's protocol ID
- ACTEffectiveness
- Acronym
- ACTE
- Status last verified
- Jul 2015
- First submitted
- 20 Nov 2009
- Last updated
- 31 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artemether-lumefantrine Vs Co-formulated Amodiaquine + Artesunate for the Treatment of Uncomplicated Falciparum Malaria: a Randomized Open-label Trial to Evaluate the Effectiveness of the Burkina Faso New Drug Policy
- ClinicalTrials.gov ID
- NCT01017770
- Acronym / sponsor ID
- ACTE / ACTEffectiveness
- Keywords
- Uncomplicated malaria
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- Centre MurazUniversity, hospital or other
- Collaborators
- Institute of Tropical Medicine, Belgium
- Study start
- Sep 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 23 Nov 2009 (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.
Several countries in Africa have changed their first-line treatment for uncomplicated malaria to an ACT. Burkina Faso has changed its policy to Artemether-Lumefantrine (AL) and Artesunate-Amodiaquine (AQ+AS). However, such choice has been done without knowing the local effectiveness of these drugs when they are given to patients in real life conditions, without direct observation of the drug administration. Thus, this study aims at investigating the effectiveness of AQ+AS and AL, when given to children with uncomplicated malaria in Burkina Faso.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Artemether -lumefantrine | Experimental | Drug: Artemether-lumefantrineExperimental Treatment of malaria with Artemether-lumefantrine (AL), according to one of the two options given by national protocol in Burkina Faso |
| Artesunate-amodiaquine | Experimental | Drug: Artesunate-amodiaquineTreatment of malaria with Artesunate-amodiaquine(AS-AQ), according to one of the two options given by national protocol in Burkina Faso |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Weight > 5 kg;
- Monoinfection with P. falciparum and a parasitaemia of 2,000-200,000 parasites /µl;
- Fever (axillary temperature ≥37.5 °C) or history of fever in the preceding 24 hours;
- Haemoglobin value above 5.0 g/dl;
- Absence of febrile conditions caused by diseases other than malaria.
Key exclusion criteria (6 listed)
- Danger signs: not able to drink or breast-feed, vomiting (> twice in 24hours), recent history of convulsions (>1 in 24h), unconscious state, unable to sit or stand;
- Signs of severe malaria (WHO 2000);
- Mixed malaria infection;
- Severe malnutrition;
- Other underlying diseases (cardiac, renal, hepatic diseases);
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-amodiaquineAlso: ASAQ, CoarsucamCoformulated AQ+AS by Sanofi-Aventis has been pre-qualified by WHO in 2008. It is administered once daily for three consecutive days, and it is available in three different dosages (25mg/67.5mg; 50mg/135mg; 100mg/270mg) | Drug | Artesunate-amodiaquine |
| Artemether-lumefantrineAlso: AL, Coartem(R), Riamet(R)Artemether-lumefantrine by Novartis was the first fixed-dose ACT that was prequalified by WHO in April 2004. A 3-day, 6-dose regimen of AL is recommended for infants and children weighing 5-35 kg and adults weighing > 35 kg. | Drug | Artemether -lumefantrine |
Primary outcome
Polymerase chain reaction (PCR) adjusted treatment failure
Time frame: Day 28
3 secondary outcomes
Treatment failure up to day 42 (PCR adjusted and unadjusted)
Time frame: Day 42
Gametocytes (prevalence and density)
Time frame: At day 7, 14, 21, 28, 35 and 42 days after treatment
Hb changes
Time frame: Day 35
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 31 Jul 2015.
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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites 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-amodiaquine and Artemether-lumefantrine in people with Uncomplicated P. Falciparum Malaria in Children, run by Centre Muraz at 4 sites in Burkina Faso.
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 5 inclusion and 6 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 31 Jul 2015. 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 Burkina Faso. 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?
Polymerase chain reaction (PCR) adjusted treatment failure (time frame: Day 28). 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 31 Jul 2015.