MalariaPhase 4NCT01755559
Efficacy of Three ACTs for the Treatment of Falciparum Malaria in Maradi Niger
A Phase 4 study testing Artesunate-amodiaquine, Dihydroartemisinin-piperaquine and Artemether-lumefantrine in people with Malaria, run by Epicentre at 1 site in Niger.
Trial summary
Study treatments: Artemether-lumefantrine Artesunate-amodiaquine Dihydroartemisinin-piperaquine Location: Maradi, Niger Principal Objective: To measure the clinical and parasitological efficacy of the three artemisinin combination therapies over a period of 42 days from the start of treatment and with polymerase chain… Read more about this study
- Who is it for?
- Ages 6 to 59 months
- Conditions the study is for
- Malaria
- What is being tested?
- Artesunate-amodiaquine, Dihydroartemisinin-piperaquine and Artemether-lumefantrine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 663 participants
- Where
- 1 siteNiger
- Study dates
- Jun 2013to Nov 2014
- 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
- Age between 6 and 59 months
- Weight ≥ 5 kg
- Mono-infection with P. falciparum detected by microscopy
- Parasitic density between 2,000 and 200,000 asexual forms /µL of blood
- Axillary temperature ≥ 37.5°C or history of fever during the previous 24 hours
- Ability and willingness to comply with the protocol for the duration of the study and to comply with the study visit schedule (home is within one hour of walk from the outpatient department, no near-term travel plans, etc.)
- Consent of a parent or guardian who is at least 18 years of age.
Who cannot join
- Presence of general danger signs as defined by the WHO,
- Presence of signs of severe malaria according to the definitions of WHO,
- Severe anemia (haemoglobin <5 g/dL),
- Known history of symptomatic cardiac arrhythmias or with clinically relevant bradycardia,
- Family history of sudden death or of congenital prolongation of corrected QT interval,
- Use of antiarrhythmics or neuroleptics,
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- Known history of hypersensitivity to any of the study medications,
- Severe malnutrition (defined as a weight-height ratio of < -3 z-score according to the 2006 WHO reference (20) and / or a mid-upper arm circumference lower than 115 mm and / or the presence of symmetrical oedema of the feet),
- Presence of a febrile condition due to a disease other than malaria (i.e. measles, acute lower respiratory tract infection, otitis media, tonsillitis, abscess, severe diarrhoea with dehydration, etc.)
- History of a full treatment course with one of the three study drugs in the past 28 days. The prior incomplete intake of one of the three study drugs or prior intake of antimalarial drugs not being tested in the study does not exclude a patient from participating in this study. However, information on these previous treatments will be carefully recorded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Artesunate-amodiaquine, Dihydroartemisinin-piperaquine and Artemether-lumefantrine Combination Therapies for the Treatment of Uncomplicated Plasmodium Falciparum Malaria in Children Aged 6 to 59 Months in Maradi, Niger 2012-13
Study treatments:
- Artemether-lumefantrine
- Artesunate-amodiaquine
- Dihydroartemisinin-piperaquine
Read more
Location:
Maradi, Niger
Principal Objective:
To measure the clinical and parasitological efficacy of the three artemisinin combination therapies over a period of 42 days from the start of treatment and with polymerase chain reaction assay (PCR) adjustment.
Secondary objectives:
- To determine the blood concentration of the non-artemisinin component of the treatment (lumefantrine, desethylamodiaquine or piperaquine) at day 7
- To assess the incidence of adverse events during the follow-up period;
- To measure speed of parasite clearance
Methods:
In vivo non comparative study as for WHO standardised protocol. The study also measure the concentration of the non-artemisinin component.
Target population:
Children under 5 years of age consulting the integrated health centres of Andoumé and Dix-sept portes in Maradi.
Sample size:
221 patients per study treatment; 663 patients in total.
Treatment allocation:
Random.
Outcomes:
- Early treatment failure,
- Late clinical failure,
- Late parasitological failure,
- Adequate clinical and parasitological response.
Analysis:
- Cumulative success or failure rate (Kaplan-Meier analysis).
- Proportions of early treatment failures, late clinical failures, late parasitological failures, and adequate clinical and parasitological response (called also Per-protocol analysis).
- Conditions
- Malaria
- Being tested
- Artesunate-amodiaquine, Dihydroartemisinin-piperaquine, Artemether-lumefantrine
- Keywords
- malaria, artemisinin, artemisinin-based combination therapies, Plasmodium falciparum, efficacy
- Medical subject headings
- Malaria, Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artesunate-amodiaquineDrug
Also called AS-AQ Winthrop® Sanofi Aventis
antimalarial ACT
Dihydroartemisinin-piperaquineDrug
Also called Euratesim, Sigma-Tau
antimalarial ACT
Artemether-lumefantrineDrug
Also called Coartem, Novartis
antimalarial ACT
| Study group | Role | What they receive |
|---|---|---|
| Artesunate-amodiaquine | Other | Efficacy estimates at 95% Receives: Drug: Artesunate-amodiaquine |
| Dihydroartemisinin-piperaquine | Other | Efficacy estimates at 95% Receives: Drug: Dihydroartemisinin-piperaquine |
| Artemether-lumefantrine | Other | Efficacy estimates at 95% Receives: Drug: Artemether-lumefantrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adequate clinical and parasitological response
Absence of parasitaemia on day 42, irrespective of axillary temperature, in patients who did not previously meet any of the criteria of early treatment failure, late clinical failure or late parasitological failure.
Measured: 42 days after treatement start
Secondary outcomes (3)
Early treatment failure
- General danger signs or signs of severe malaria on days 1, 2, or 3, in the presence of parasitaemia , or
- Parasitaemia on day 2 higher than on day 0, irrespective of axillary temperature, or
- Parasitaemia on day 3 with axillary temperature ≥ 37.5°C, or
- Parasitaemia on day 3 ≥ 25% count on day 0 irrespective of axillary temperature.
Measured: 1 to 3 days after tratment start
Late clinical failure
- General danger signs or severe malaria in the presence of parasitaemia on any day between day 4 and day 42 in patients who did not previously meet any of the criteria of early treatment failure; or
- Presence of parasitaemia on any day between day 4 and day 42 with axillary temperature ≥ 37.5 °C in patients who did not previously meet any of the criteria of early treatment failure.
Measured: from day 4 to day 42 after treatment start
Late Parasitological Failure
- Presence of parasitaemia on any day between day 7 and day 42 with axillary temperature < 37.5 °C in patients who did not previously meet any of the criteria of early treatment failure or late clinical failure.
Measured: from day 7 to day 42 after treatment start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2012 (estimated)
- Study startJun 2013
- Primary completionNov 2014
- Study completionNov 2014
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.
- 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 663 participants (actual)
Sponsor and investigators
- Lead sponsor
- Epicentre
- Sponsor type
- University, hospital or other
- Collaborators
- Centre de Recherche Médicale et Sanitaire (Cermes), Niamey
- Responsible party
- Sponsor
- Investigators
- Francesco Grandesso, MSc, Principal investigator, EpicentreLynda Woi Messe, MD, Study chair, EpicentreIbrahim M Laminou, PhD, Study chair, CermesJean-François Etard, PhD, Study chair, Epicentre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01755559
- Sponsor's protocol ID
- Epicentre/Nig/2012/Palu3ACT
- Status last verified
- Nov 2015
- First submitted
- 19 Dec 2012
- Last updated
- 30 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Grandesso F, Guindo O, Woi Messe L, Makarimi R, Traore A, Dama S, Laminou IM, Rigal J, de Smet M, Ouwe Missi Oukem-Boyer O, Doumbo OK, Djimde A, Etard JF. Efficacy of artesunate-amodiaquine, dihydroartemisinin-piperaquine and artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in Maradi, Niger. Malar J. 2018 Jan 25;17(1):52. doi: 10.1186/s12936-018-2200-1.
PubMed 29370844
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Artesunate-amodiaquine, Dihydroartemisinin-piperaquine and Artemether-lumefantrine Combination Therapies for the Treatment of Uncomplicated Plasmodium Falciparum Malaria in Children Aged 6 to 59 Months in Maradi, Niger 2012-13
- ClinicalTrials.gov ID
- NCT01755559
- Acronym / sponsor ID
- Epicentre/Nig/2012/Palu3ACT
- Conditions
- Malaria
- Keywords
- malaria, artemisinin, artemisinin-based combination therapies, Plasmodium falciparum, efficacy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 663 participants (actual)
- Lead sponsor
- EpicentreUniversity, hospital or other
- Collaborators
- Centre de Recherche Médicale et Sanitaire (Cermes), Niamey
- Study start
- Jun 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 24 Dec 2012 (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.
Study treatments:
- Artemether-lumefantrine
- Artesunate-amodiaquine
- Dihydroartemisinin-piperaquine
Location:
Maradi, Niger
Principal Objective:
To measure the clinical and parasitological efficacy of the three artemisinin combination therapies over a period of 42 days from the start of treatment and with polymerase chain reaction assay (PCR) adjustment.
Secondary objectives:
- To determine the blood concentration of the non-artemisinin component of the treatment (lumefantrine, desethylamodiaquine or piperaquine) at day 7
- To assess the incidence of adverse events during the follow-up period;
- To measure speed of parasite clearance
Methods:
In vivo non comparative study as for WHO standardised protocol. The study also measure the concentration of the non-artemisinin component.
Target population:
Children under 5 years of age consulting the integrated health centres of Andoumé and Dix-sept portes in Maradi.
Sample size:
221 patients per study treatment; 663 patients in total.
Treatment allocation:
Random.
Outcomes:
- Early treatment failure,
- Late clinical failure,
- Late parasitological failure,
- Adequate clinical and parasitological response.
Analysis:
- Cumulative success or failure rate (Kaplan-Meier analysis).
- Proportions of early treatment failures, late clinical failures, late parasitological failures, and adequate clinical and parasitological response (called also Per-protocol analysis).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Artesunate-amodiaquine | Other | Drug: Artesunate-amodiaquineEfficacy estimates at 95% |
| Dihydroartemisinin-piperaquine | Other | Drug: Dihydroartemisinin-piperaquineEfficacy estimates at 95% |
| Artemether-lumefantrine | Other | Drug: Artemether-lumefantrineEfficacy estimates at 95% |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Age between 6 and 59 months
- Weight ≥ 5 kg
- Mono-infection with P. falciparum detected by microscopy
- Parasitic density between 2,000 and 200,000 asexual forms /µL of blood
- Axillary temperature ≥ 37.5°C or history of fever during the previous 24 hours
Key exclusion criteria (10 listed)
- Presence of general danger signs as defined by the WHO,
- Presence of signs of severe malaria according to the definitions of WHO,
- Severe anemia (haemoglobin <5 g/dL),
- Known history of symptomatic cardiac arrhythmias or with clinically relevant bradycardia,
- Family history of sudden death or of congenital prolongation of corrected QT interval,
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: AS-AQ Winthrop® Sanofi Aventisantimalarial ACT | Drug | Artesunate-amodiaquine |
| Dihydroartemisinin-piperaquineAlso: Euratesim, Sigma-Tauantimalarial ACT | Drug | Dihydroartemisinin-piperaquine |
| Artemether-lumefantrineAlso: Coartem, Novartisantimalarial ACT | Drug | Artemether-lumefantrine |
Primary outcome
Adequate clinical and parasitological response
Time frame: 42 days after treatement start
Absence of parasitaemia on day 42, irrespective of axillary temperature, in patients who did not previously meet any of the criteria of early treatment failure, late clinical failure or late parasitological failure.
3 secondary outcomes
Early treatment failure
Time frame: 1 to 3 days after tratment start
Late clinical failure
Time frame: from day 4 to day 42 after treatment start
Late Parasitological Failure
Time frame: from day 7 to day 42 after treatment start
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 30 Nov 2015.
- Derived from this study: PubMed 29370844Grandesso F, Guindo O, Woi Messe L, Makarimi R, Traore A, Dama S, Laminou IM, Rigal J, de Smet M, Ouwe Missi Oukem-Boyer O, Doumbo OK, Djimde A, Etard JF. Efficacy of artesunate-amodiaquine, dihydroartemisinin-piperaquine and artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in Maradi, Niger. Malar J. 2018 Jan 25;17(1):52. doi: 10.1186/s12936-018-2200-1.
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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.
Francesco Grandesso, MSc principal investigator
Epicentre
Lynda Woi Messe, MD study chair
Epicentre
Ibrahim M Laminou, PhD study chair
Cermes
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-amodiaquine, Dihydroartemisinin-piperaquine and Artemether-lumefantrine in people with Malaria, run by Epicentre at 1 site in Niger.
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 10 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 30 Nov 2015. 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 Niger. 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?
Adequate clinical and parasitological response (time frame: 42 days after treatement start). 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 NCT01755559, 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 30 Nov 2015.