Safety and Efficacy Study of Artesunate and Mefloquin in Children With Uncomplicated Malaria

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

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."

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mepha Ltd.
• Collaborator: Centre Mère et Enfant de la Fondation Chantal Biya
• Treatments: Artemisinins; Artesunate; Mefloquine

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.