Status:
COMPLETED
Safety and Efficacy Study of Artesunate and Mefloquin in Children With Uncomplicated Malaria
Lead Sponsor:
Mepha Ltd.
Collaborating Sponsors:
Centre Mère et Enfant de la Fondation Chantal Biya
Conditions:
Malaria
Eligibility:
All Genders
Phase:
PHASE4
Brief 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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT00978172
Start Date
December 1 2007
End Date
March 1 2009
Last Update
September 16 2009
Active Locations (1)
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1
Centre Mère et Enfant, Fondation Chantal Biya
Yaoundé, Yaounde, Cameroon, BP 1936