Efficacy, Safety and Pharmacokinetic of ArtequinTM P. Falciparum Malaria

January 23, 2013 updated by: Albert Schweitzer Hospital

Open-label, Stratified Study on the Efficacy, Safety and Pharmacokinetic Characteristics of Two Paediatric Formulations of ArtequinTM in Children With Acute Uncomplicated P. Falciparum Malaria

Treatment of Plasmodium falciparum malaria in Africa is increasingly difficult. Resistance to cheap efficient antimalarial drugs poses an increasing threat. The rapid emergence of resistance to sulfadoxine - pyrimethamine, already seen in East Africa is growing and is likely to have an striking impact on mortality in many other African regions where no obvious alternatives are available. WHO recommends the use of drug combinations containing artemisinin compounds, i.e., artemisinin-based combination therapies (ACT). Previous clinical trials have shown that the combination of artesunate with mefloquine is highly effective and well tolerated in the treatment of multidrug-resistant falciparum malaria, retaining the benefit of rapidity of action while augmenting cure rates, and apparently slowing the development of mefloquine resistance. Compliance with sequential combination regimen of antimalarial drugs is notoriously poor. Therefore, in order to limit the development of resistance to both drugs and ameliorate patients' compliance to antimalarial treatments, an optimal simultaneous combination regimen of artesunate and mefloquine in a practical single blister pack has been developed by Mepha Ltd. and successfully tested. The currently available

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Artequin dosages could only be tested in children able to swallow tablets and with a body weight of more than 20 kg. However, there is a great need for an Artequin formulation for smaller children unable to swallow tablets. The new Artequin Paediatric oral formulation is a flavoured, taste-masked preparation of granules of 50 mg artesunate and 125 mg mefloquine as a fixed-dose combination (once daily in one single Stickpack, i.e. 3 Stickpacks for a 3-day treatment). It is suitable for children with up to 20 kg body weight (with a range of 10-20 kg).

Study Type

Interventional

Enrollment

70

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Gabon
      • Lambarene, Gabon
        • Medical Research Unit, Albert Schweitzer Hospital
      • Libreville, Gabon
        • Département de Parasitologie-Mycologie, Faculte de medecine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Male or female with a body weight ≥10 to 40 kg

  • Patients suffering from acute uncomplicated Plasmodium falciparum malaria
  • Malaria diagnosis confirmed by a positive blood smear with asexual forms of Plasmodium falciparum (i.e., identification of asexual parasite count ≥1,000 to 250,000 per mm3)
  • Ear temperature 37.5°C or a history of fever within the last 48 hours
  • Haemoglobin 7g/100ml
  • Written informed consent and written consent from parents/guardian for children below age of consent (verbal consent in presence of literate witness is required for illiterate patients or parents/guardians).

Exclusion Criteria:

Patients with signs and symptoms of severe/complicated malaria requiring parenteral treatment (defined according to WHO Recommendations "Malaria Control Today", RBM Working Document, March 2005, see Appendix 2)

  • Patients with known hypersensitivity or allergy to artemisinin derivatives or mefloquine or mefloquine chemically related compounds (for example quinine and quinidine)
  • Patients who had received quinine or any artemisinin derivatives within 12 hours prior to study start
  • Patients who had received any other adequate antimalarial drug therapy including antibiotics which might be active against malaria infection within 1 week prior to study start
  • Patients who had received investigational (unlicensed) drugs as well as mefloquine within 30 days prior to study start
  • Patients with known history of psychiatric disorders
  • Patients with known history of cardiac diseases and arrhythmia
  • Patients with known sickle cell disease
  • Patients with clinical signs of or laboratory evidence for any other severe hepatic, renal, pulmonary, cardiac, metabolic, psychiatric, cancer or haematologic diseases
  • Pregnancy or lactation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Efficacy, Proportion of patients cured on day 28

Secondary Outcome Measures

Outcome Measure
Measure Description
Efficacy: day 14v cure rate, parasite and fever clearance time, parasite reduction rate, gametocytemia, in relation to blood concentrations of Dihydroartemisinin and mefloquine, safety, tolerability, acceptability
parasite and fever clearance time, parasite reduction rate, gametocytemia, in relation to blood concentrations of Dihydroartemisinin
Time to complete clearance of fever and parasitemia Assessment in relation to DHA and mefloquine blood levels
safety, tolerability, acceptability
Assessment of adverse events and reporting of tolerability, safety and acceptability

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Albert Schweitzer Hospital

Collaborators

Mepha Ltd.

Investigators

  • Principal Investigator: Maryvonne Kombila, Prof Dr, Département de Parasitologie-Mycologie, Faculte de medecine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Study Completion

April 1, 2006

Study Registration Dates

First Submitted

October 24, 2005

First Submitted That Met QC Criteria

October 24, 2005

First Posted (ESTIMATE)

October 25, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

January 24, 2013

Last Update Submitted That Met QC Criteria

January 23, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AM-P 001-2005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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