Malaria, FalciparumPhase 4NCT01204411
Efficacy of Artesunate-amodiaquine (AS-AQ) in Children With Malaria and Severe Acute Malnutrition, Madaoua, Niger 2010
A Phase 4 study testing Artesunate-amodiaquine fixed-dose combination in people with Malaria, Falciparum and Malnutrition, run by Epicentre at 1 site in Niger.
Trial summary
The purpose of the study is to determine whether the artesunate-amodiaquine combination is effective in treating uncomplicated Plasmodium falciparum malaria in children with severe acute malnutrition. Read more about this study
- Who is it for?
- Ages 6 to 59 months
- Conditions the study is for
- Malaria, Falciparum, Malnutrition, Child
- What is being tested?
- Artesunate-amodiaquine fixed-dose combination
- Type of treatment
- Pill or oral medicine
- How many people
- 0 participants
- Where
- 1 siteNiger
- Study dates
- Start not givento not given
- 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 ≥5kg
- P. falciparum monoinfection confirmed on a thick blood film
- Parasitic density between 1,000 and 200,000 asexual forms/uL of blood
- Measured axillary temperature ≥37.5°C or history of fever during the previous 24 hours
- Severe malnutrition (defined as a weight/height ratio less than -3 z-scores)
- High probability of compliance with follow-up visits (home is within two hours 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
- Signs of a critical illness as defined by the WHO (WHO (2000) Severe falciparum malaria; Clinical features of severe falciparum malaria in children. Royal Society of Tropical Medicine and Hygiene, 94 (supplement 1), 5-11).
- Signs of severe or complicated malaria as defined by the WHO (WHO (2000) Severe falciparum malaria; Clinical features of severe falciparum malaria in children. Royal Society of Tropical Medicine and Hygiene, 94 (supplement 1), 5-11).
- Severe anaemia (haemoglobin <5 g/dL)
- Known history of hypersensitivity to any of the study medications,
- Symmetric oedema in the feet,
- Concomitant febrile illness not originating from malaria, which could alter the outcome of the study (measles, acute lower respiratory tract infection, otitis media, tonsillitis, abscesses, severe diarrhea with dehydration, etc.),
- History of a full treatment course with the study drug in the past 28 days.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of the Artesunate-amodiaquine Combination for Treatment of Uncomplicated Plasmodium Falciparum Malaria in Children Between 6 and 59 Months of Age With Severe Acute Malnutrition in Madaoua, Tahoua Region, Niger
The purpose of the study is to determine whether the artesunate-amodiaquine combination is effective in treating uncomplicated Plasmodium falciparum malaria in children with severe acute malnutrition.
Infection with Plasmodium falciparum malaria remains a significant cause of morbidity and mortality in malnourished children. Malnutrition is known to have a modulating effect on the incidence of malaria infections, its severity and effectiveness of treatments. However, little data exists on antimalarial drug efficacy in malnourished children. Artesunate-amodiaquine combination is the first line treatment used in Médecins Sans Frontières programmes in Niger. The assumption of current efficacy of artesunate-amodiaquine is based on non malnourished children. The aim of this study is to measure the clinical and parasitological efficacy in severely malnourished children.
The study is consistent with the standard WHO protocol for monitoring antimalarial drug efficacy (WHO: Methods for surveillance of antimalarial drug efficacy. Geneva; 2009), except for one inclusion criterion. Severe acute malnutrition is an inclusion criteria, instead of being an exclusion criteria. The study will encompass a pharmacokinetic part that will provide important information on the absorption of the drug.
- Conditions
- Malaria, Falciparum, Malnutrition, Child
- Being tested
- Artesunate-amodiaquine fixed-dose combination
- Keywords
- Efficacy, Safety, Artesunate-amodiaquine, Malaria, Plasmodium falciparum, Malnutrition
- Medical subject headings
- Malaria, Falciparum, Malnutrition, Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artesunate-amodiaquine fixed-dose combinationDrug
Also called AS-AQ Winthrop® Sanofi Aventis
- artesunate 25 mg / amodiaquine 67.5 mg: 1 tablet / day for 3 days for children with a weight of 5 kg to less than 9 kg;
- artesunate 50 mg / amodiaquine 135 mg: 1 tablet / day for 3 days for children with a weight of 9 kg to less than 18 kg;
- artesunate 100 mg / amodiaquine 270 mg: 1 tablet / day for 3 days for children with a weight of 18 kg to less than 36 kg;
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure the PCR adjusted clinical and parasitological efficacy of the artesunate-amodiaquine combination in children 6-59 months of age with severe malnutrition and uncomplicated P. falciparum malaria over a period of 42 days.
Measured: 42 day follow-up
Secondary outcomes (1)
To assess the incidence of adverse events during the follow-up period
Measured: 42 day follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2010 (estimated)
Why it stopped: The ethics committee did not approve the pharmacokinetic part of the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malaria, FalciparumStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Epicentre
- Sponsor type
- University, hospital or other
- Collaborators
- Medecins Sans Frontieres, Spain
- Responsible party
- Sponsor
- Investigators
- Francesco Grandesso, MSc, Principal investigator, Epicentre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01204411
- Sponsor's protocol ID
- Epicentre/Nig/2010/PaluMadaua
- Status last verified
- Nov 2012
- First submitted
- 16 Sep 2010
- Last updated
- 30 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the Artesunate-amodiaquine Combination for Treatment of Uncomplicated Plasmodium Falciparum Malaria in Children Between 6 and 59 Months of Age With Severe Acute Malnutrition in Madaoua, Tahoua Region, Niger
- ClinicalTrials.gov ID
- NCT01204411
- Acronym / sponsor ID
- Epicentre/Nig/2010/PaluMadaua
- Conditions
- Malaria, Falciparum, Malnutrition, Child
- Keywords
- Efficacy, Safety, Artesunate-amodiaquine, Malaria, Plasmodium falciparum, Malnutrition
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The ethics committee did not approve the pharmacokinetic part of the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- EpicentreUniversity, hospital or other
- Collaborators
- Medecins Sans Frontieres, Spain
- First posted
- 17 Sep 2010 (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 the study is to determine whether the artesunate-amodiaquine combination is effective in treating uncomplicated Plasmodium falciparum malaria in children with severe acute malnutrition.
Infection with Plasmodium falciparum malaria remains a significant cause of morbidity and mortality in malnourished children. Malnutrition is known to have a modulating effect on the incidence of malaria infections, its severity and effectiveness of treatments. However, little data exists on antimalarial drug efficacy in malnourished children. Artesunate-amodiaquine combination is the first line treatment used in Médecins Sans Frontières programmes in Niger. The assumption of current efficacy of artesunate-amodiaquine is based on non malnourished children. The aim of this study is to measure the clinical and parasitological efficacy in severely malnourished children.
The study is consistent with the standard WHO protocol for monitoring antimalarial drug efficacy (WHO: Methods for surveillance of antimalarial drug efficacy. Geneva; 2009), except for one inclusion criterion. Severe acute malnutrition is an inclusion criteria, instead of being an exclusion criteria. The study will encompass a pharmacokinetic part that will provide important information on the absorption of the drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Age between 6 and 59 months
- Weight ≥5kg
- P. falciparum monoinfection confirmed on a thick blood film
- Parasitic density between 1,000 and 200,000 asexual forms/uL of blood
- Measured axillary temperature ≥37.5°C or history of fever during the previous 24 hours
Key exclusion criteria (7 listed)
- Signs of a critical illness as defined by the WHO (WHO (2000) Severe falciparum malaria; Clinical features of severe falciparum malaria in children. Royal Society of Tropical Medicine and Hygiene, 94 (supplement 1), 5-11).
- Signs of severe or complicated malaria as defined by the WHO (WHO (2000) Severe falciparum malaria; Clinical features of severe falciparum malaria in children. Royal Society of Tropical Medicine and Hygiene, 94 (supplement 1), 5-11).
- Severe anaemia (haemoglobin <5 g/dL)
- Known history of hypersensitivity to any of the study medications,
- Symmetric oedema in the feet,
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 fixed-dose combinationAlso: AS-AQ Winthrop® Sanofi Aventis* artesunate 25 mg / amodiaquine 67.5 mg: 1 tablet / day for 3 days for children with a weight of 5 kg to less than 9 kg; * artesunate 50 mg / amodiaquine 135 mg: 1 tablet / day for 3 days for children with a weight of 9 kg to less than 18 kg; * artesunate 100 mg / amodiaquine 270 mg: 1 tablet / day for 3 days for children with a weight of 18 kg to less than 36 kg; | Drug | – |
Primary outcome
To measure the PCR adjusted clinical and parasitological efficacy of the artesunate-amodiaquine combination in children 6-59 months of age with severe malnutrition and uncomplicated P. falciparum malaria over a period of 42 days.
Time frame: 42 day follow-up
1 secondary outcome
To assess the incidence of adverse events during the follow-up period
Time frame: 42 day follow-up
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2012.
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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
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 fixed-dose combination in people with Malaria, Falciparum and Malnutrition, 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 8 inclusion and 7 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: withdrawn, as of the sponsor's last update on 30 Nov 2012. 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 was withdrawn before enrolling participants, so there are no results.
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?
To measure the PCR adjusted clinical and parasitological efficacy of the artesunate-amodiaquine combination in children 6-59 months of age with severe malnutrition and uncomplicated P. falciparum malaria over a period of 42 days. (time frame: 42 day follow-up). 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 30 Nov 2012.