Safety and Efficacy Study of Artesunate and Mefloquin in Children With Uncomplicated Malaria
Information source: Mepha Ltd.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Malaria
Intervention: artesunate and mefloquine (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Mepha Ltd. Official(s) and/or principal investigator(s):
Felix Tietche, Prof, Principal Investigator, Affiliation: Faculty of Medicine and Biomedical Sciences University of Yaounde (Cameroon)
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."
Clinical Details
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
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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
Secondary outcome: To determine further safety and effectiveness parameters of Artequin Paediatric
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.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Centre Mère et Enfant, Fondation Chantal Biya, Yaounde BP 1936, Cameroon
Additional Information
Starting date: December 2007
Last updated: September 15, 2009
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