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

NCT00978172 | Completed Phase 4

• 1 other identifier: ART-P 001-2007
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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 of Artequin Paediatric under "real life conditions."

Conditions

Malaria

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline (day1), day 7, day 28, day 63

Secondary Outcomes (1)

• To determine further safety and effectiveness parameters of Artequin Paediatric

  Baseline (day1), day 4, day7, day 28, day 63

Interventions

artesunate and mefloquine DRUG

artesunate (50 mg/day) and mefloquine (125 mg/day) fixed dose formulation (stick pack) once daily for 3 consecutive days, orally

Also known as: Artequin[TM] Paediatric stickpack

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mepha Ltd.: lead
• Centre Mère et Enfant de la Fondation Chantal Biya: collaborator

Study Sites (1)

Centre Mère et Enfant, Fondation Chantal Biya

Yaoundé, Yaounde, BP 1936, Cameroon

Location

MeSH Terms

Conditions

Malaria

Interventions

Artesunate; Mefloquine

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Artemisinins; Reactive Oxygen Species; Free Radicals; Inorganic Chemicals; Organic Chemicals; Sesquiterpenes; Terpenes; Hydrocarbons; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Felix Tietche, Prof

  Faculty of Medicine and Biomedical Sciences University of Yaounde (Cameroon)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 10, 2009
• First Posted: September 16, 2009
• Study Start: December 1, 2007
• Study Completion: March 1, 2009
• Last Updated: September 16, 2009

Record last verified: 2009-09

Locations

CA (1)