- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00978172
Safety and Efficacy Study of Artesunate and Mefloquin in Children With Uncomplicated Malaria
September 15, 2009 updated by: Mepha Ltd.
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."
Study Overview
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 Type
Interventional
Enrollment (Actual)
220
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Yaounde, Cameroon, BP 1936
- Centre Mère et Enfant, Fondation Chantal Biya
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Baseline (day1), day 7, day 28, day 63
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To determine further safety and effectiveness parameters of Artequin Paediatric
Time Frame: Baseline (day1), day 4, day7, day 28, day 63
|
Baseline (day1), day 4, day7, day 28, day 63
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Felix Tietche, Prof, Faculty of Medicine and Biomedical Sciences University of Yaounde (Cameroon)
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2007
Study Completion (Actual)
March 1, 2009
Study Registration Dates
First Submitted
September 10, 2009
First Submitted That Met QC Criteria
September 15, 2009
First Posted (Estimate)
September 16, 2009
Study Record Updates
Last Update Posted (Estimate)
September 16, 2009
Last Update Submitted That Met QC Criteria
September 15, 2009
Last Verified
September 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ART-P 001-2007
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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