MalariaPhase 4NCT00978172
Safety and Efficacy Study of Artesunate and Mefloquin in Children With Uncomplicated Malaria
A Phase 4 study testing artesunate and mefloquine in people with Malaria, run by Mepha Ltd. at 1 site in Cameroon.
Trial summary
The present study aims to investigate and to assess possible neurological and neuropsychiatric events in young children in west Africa with uncomplicated P. falciparum malaria after a 3-day treatment of Artequin Paediatric under "real life conditions." Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Malaria
- What is being tested?
- artesunate and mefloquine
- Type of treatment
- Pill or oral medicine
- How many people
- 220 participants
- Where
- 1 siteCameroon
- Study dates
- Dec 2007to Mar 2009
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Body weight from ≥ 10 kg to ≤ 20 kg.
- Presence of acute uncomplicated P. falciparum malaria with a diagnosis confirmed by a positive blood smear with asexual forms of P. falciparum only.
- Counts of asexual forms of P. falciparum: 2'000 to 250'000 parasites per µL of blood.
- Presence of fever defined as axillary temperature of ≥37.5 °C (≥ 38 °C if oral, rectal or tympanic temperature) or a history of fever within the last 24 hours.
- Written informed consent provided by the patient and parent or guardian. If the person is unable to write, thumb print witnessed consent is permitted.
- Willingness and ability of the patient and the parent or guardian to comply with study protocol for the duration of the study.
- Patients who are able to take oral medication.
Who cannot join
- Patients with severe/complicated malaria as defined by the World Health Organization, 2000, Severe falciparum malaria (18).
- Known history or evidence of clinically significant disorders: neurological, psychiatric (depression, psychosis or schizophrenia), cardiovascular (including arrhythmia), pulmonary, metabolic, gastrointestinal, endocrine diseases or malignancies.
- Patients with a history of epilepsy or of convulsions.
- Patients who received any anti-malarial treatment within 7 days prior to enrolment including any substance with anti-malarial activity, e.g. antibiotics)or treatment with mefloquine within 30 days prior to enrolment.
- Patients with a hypersensitivity or allergic reaction to artemisinins or mefloquine or any chemically related entity (e.g. quinine).
- Patients who participated in any investigational drug trial within 30 days prior to enrolment.
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- Patients with vomiting 3 or more times within 24 hours of enrolment or more than 3 copious liquid stools within 24 hours.
- Patients with known renal impairment.
- Patients who do require parenteral treatment.
- Patients who have had a splenectomy.
- Known immunocompromised patients and who are receiving immunosuppressive agents and/or patients with known human immunodeficiency virus (HIV) infection.
Trial locations and contacts
1 site in 1 country.
Cameroon1 site
Centre Mère et Enfant, Fondation Chantal Biya
Yaoundé, Yaounde, BP 1936
About this study
Official title: A Phase IV Study on the Safety and Effectiveness of a Fixed-dose Combination of Artesunate and Mefloquine (Artequin[TM] Paediatric) Administered for 3 Days in Children With Uncomplicated Plasmodium Falciparum Malaria in Africa
The present study aims to investigate and to assess possible neurological and neuropsychiatric events in young children in west Africa with uncomplicated P. falciparum malaria after a 3-day treatment of Artequin Paediatric under "real life conditions."
Read the detailed description
The study aims investigating the safety profile of Artequin Paediatric in a 3-day treatment of children with uncomplicated P. falciparum malaria under "real life conditions" in West Africa. Important parameters, such as concomitant medication, the patient's medical history and diseases, differential WBC counts, the presence of parasitaemia as well as the patient's compliance are evaluated. Detailed recording of possible AEs and SAEs enable additionally an assessment of the safety and effectiveness of Artequin Paediatric over a period of 63 days following treatment initiation. The present study primarily serves to detect and assess possible neuropsychiatric and neurological events in young children using a standardized questionnaire and axamination.
- Conditions
- Malaria
- Being tested
- artesunate and mefloquine
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
artesunate and mefloquineDrug
Also called Artequin[TM] Paediatric stickpack
artesunate (50 mg/day) and mefloquine (125 mg/day) fixed dose formulation (stick pack) once daily for 3 consecutive days, orally
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the neuropsychiatric and neurological safety of a fixed-dose combination of artesunate and mefloquine (Artequin Paediatric) in the treatment of children (>=10kg to <=20kg body weight) with uncomplicated P. falciparum malaria
Measured: Baseline (day1), day 7, day 28, day 63
Secondary outcomes (1)
To determine further safety and effectiveness parameters of Artequin Paediatric
Measured: Baseline (day1), day 4, day7, day 28, day 63
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2009 (estimated)
- Study startDec 2007
- Study completionMar 2009
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.
- 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
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mepha Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Centre Mère et Enfant de la Fondation Chantal Biya
- Investigators
- Felix Tietche, Prof, Principal investigator, Faculty of Medicine and Biomedical Sciences University of Yaounde (Cameroon)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00978172
- Sponsor's protocol ID
- ART-P 001-2007
- Status last verified
- Sep 2009
- First submitted
- 10 Sep 2009
- Last updated
- 16 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV Study on the Safety and Effectiveness of a Fixed-dose Combination of Artesunate and Mefloquine (Artequin[TM] Paediatric) Administered for 3 Days in Children With Uncomplicated Plasmodium Falciparum Malaria in Africa
- ClinicalTrials.gov ID
- NCT00978172
- Acronym / sponsor ID
- ART-P 001-2007
- Conditions
- Malaria
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Mepha Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Centre Mère et Enfant de la Fondation Chantal Biya
- Study start
- Dec 2007
- Study completion
- Mar 2009 (actual)
- First posted
- 16 Sep 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.
The present study aims to investigate and to assess possible neurological and neuropsychiatric events in young children in west Africa with uncomplicated P. falciparum malaria after a 3-day treatment of Artequin Paediatric under "real life conditions."
Detailed description
The study aims investigating the safety profile of Artequin Paediatric in a 3-day treatment of children with uncomplicated P. falciparum malaria under "real life conditions" in West Africa. Important parameters, such as concomitant medication, the patient's medical history and diseases, differential WBC counts, the presence of parasitaemia as well as the patient's compliance are evaluated. Detailed recording of possible AEs and SAEs enable additionally an assessment of the safety and effectiveness of Artequin Paediatric over a period of 63 days following treatment initiation. The present study primarily serves to detect and assess possible neuropsychiatric and neurological events in young children using a standardized questionnaire and axamination.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Body weight from ≥ 10 kg to ≤ 20 kg.
- Presence of acute uncomplicated P. falciparum malaria with a diagnosis confirmed by a positive blood smear with asexual forms of P. falciparum only.
- Counts of asexual forms of P. falciparum: 2'000 to 250'000 parasites per µL of blood.
- Presence of fever defined as axillary temperature of ≥37.5 °C (≥ 38 °C if oral, rectal or tympanic temperature) or a history of fever within the last 24 hours.
- Written informed consent provided by the patient and parent or guardian. If the person is unable to write, thumb print witnessed consent is permitted.
Key exclusion criteria (11 listed)
- Patients with severe/complicated malaria as defined by the World Health Organization, 2000, Severe falciparum malaria (18).
- Known history or evidence of clinically significant disorders: neurological, psychiatric (depression, psychosis or schizophrenia), cardiovascular (including arrhythmia), pulmonary, metabolic, gastrointestinal, endocrine diseases or malignancies.
- Patients with a history of epilepsy or of convulsions.
- Patients who received any anti-malarial treatment within 7 days prior to enrolment including any substance with anti-malarial activity, e.g. antibiotics)or treatment with mefloquine within 30 days prior to enrolment.
- Patients with a hypersensitivity or allergic reaction to artemisinins or mefloquine or any chemically related entity (e.g. quinine).
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 and mefloquineAlso: Artequin[TM] Paediatric stickpackartesunate (50 mg/day) and mefloquine (125 mg/day) fixed dose formulation (stick pack) once daily for 3 consecutive days, orally | Drug | – |
Primary outcome
To assess the neuropsychiatric and neurological safety of a fixed-dose combination of artesunate and mefloquine (Artequin Paediatric) in the treatment of children (>=10kg to <=20kg body weight) with uncomplicated P. falciparum malaria
Time frame: Baseline (day1), day 7, day 28, day 63
1 secondary outcome
To determine further safety and effectiveness parameters of Artequin Paediatric
Time frame: Baseline (day1), day 4, day7, day 28, day 63
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 16 Sep 2009.
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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.
Felix Tietche, Prof principal investigator
Faculty of Medicine and Biomedical Sciences University of Yaounde (Cameroon)
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 and mefloquine in people with Malaria, run by Mepha Ltd. at 1 site in Cameroon.
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 11 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 16 Sep 2009. 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 Cameroon. 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?
To assess the neuropsychiatric and neurological safety of a fixed-dose combination of artesunate and mefloquine (Artequin Paediatric) in the treatment of children (>=10kg to <=20kg body weight) with uncomplicated P. falciparum malaria (time frame: Baseline (day1), day 7, day 28, day 63). 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 16 Sep 2009.