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

Primary Purpose

Malaria

Status

Completed

Phase

Phase 4

Locations

Cameroon

Study Type

Interventional

Intervention

artesunate and mefloquine

About this trial

This is an interventional treatment trial for Malaria

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Centre Mère et Enfant, Fondation Chantal Biya

Outcomes

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

Secondary Outcome Measures

To determine further safety and effectiveness parameters of Artequin Paediatric

Full Information

NCT ID

NCT00978172

First Posted

September 10, 2009

Last Updated

September 15, 2009

Sponsor

Mepha Ltd.

Collaborators

Centre Mère et Enfant de la Fondation Chantal Biya

1. Study Identification

Unique Protocol Identification Number

NCT00978172

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

September 2009

Overall Recruitment Status

Completed

Study Start Date

December 2007 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

March 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Mepha Ltd.

Collaborators

Centre Mère et Enfant de la Fondation Chantal Biya

4. Oversight

Data Monitoring Committee

5. Study Description

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."

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malaria

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

220 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

artesunate and mefloquine

Other Intervention Name(s)

Artequin[TM] Paediatric stickpack

Intervention Description

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

Primary Outcome Measure Information:

Title

Time Frame

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

Secondary Outcome Measure Information:

Title

To determine further safety and effectiveness parameters of Artequin Paediatric

Time Frame

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

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Felix Tietche, Prof

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

Centre Mère et Enfant, Fondation Chantal Biya

City

Yaounde

ZIP/Postal Code

BP 1936

Country

Cameroon

12. IPD Sharing Statement

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

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