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

This study has been completed.
Sponsor:
Collaborator:
Centre Mère et Enfant, Fondation Chantal Biya
Information provided by:
Mepha Ltd.
ClinicalTrials.gov Identifier:
NCT00978172
First received: September 10, 2009
Last updated: September 15, 2009
Last verified: September 2009
  Purpose

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."


Condition Intervention Phase
Malaria
Drug: artesunate and mefloquine
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Mepha Ltd.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine further safety and effectiveness parameters of Artequin Paediatric [ Time Frame: Baseline (day1), day 4, day7, day 28, day 63 ] [ Designated as safety issue: No ]

Enrollment: 220
Study Start Date: December 2007
Study Completion Date: March 2009
Intervention Details:
    Drug: artesunate and mefloquine
    artesunate (50 mg/day) and mefloquine (125 mg/day) fixed dose formulation (stick pack) once daily for 3 consecutive days, orally
    Other Name: Artequin[TM] Paediatric stickpack
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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00978172

Locations
Cameroon
Centre Mère et Enfant, Fondation Chantal Biya
Yaounde, Cameroon, BP 1936
Sponsors and Collaborators
Mepha Ltd.
Centre Mère et Enfant, Fondation Chantal Biya
Investigators
Principal Investigator: Felix Tietche, Prof Faculty of Medicine and Biomedical Sciences University of Yaounde (Cameroon)
  More Information

No publications provided

Responsible Party: Prof. Dr. Félix Tietche, Department of Paediatry, Medical faculty, University of Yaounde (Cameroun)
ClinicalTrials.gov Identifier: NCT00978172     History of Changes
Other Study ID Numbers: ART-P 001-2007
Study First Received: September 10, 2009
Last Updated: September 15, 2009
Health Authority: Cameroon: National Ethics Commitee
Cameroon: Ministry of Public Health

Additional relevant MeSH terms:
Malaria
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases
Mefloquine
Artesunate
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Amebicides

ClinicalTrials.gov processed this record on July 22, 2014