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Efficacy, Safety and Pharmacokinetic of ArtequinTM P. Falciparum Malaria

This study has been completed.
Sponsor:
Collaborator:
Mepha Ltd.
Information provided by:
Albert Schweitzer Hospital
ClinicalTrials.gov Identifier:
NCT00243737
First received: October 24, 2005
Last updated: January 23, 2013
Last verified: January 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Malaria
 Drug: Artesunate-Mefloquine
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: Malaria
U.S. FDA Resources

Further study details as provided by Albert Schweitzer Hospital:

Primary Outcome Measures:
  • Efficacy, Proportion of patients cured on day 28

Secondary Outcome Measures:
  • 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 [ Designated as safety issue: No ]
  • parasite and fever clearance time, parasite reduction rate, gametocytemia, in relation to blood concentrations of Dihydroartemisinin [ Designated as safety issue: No ]
    Time to complete clearance of fever and parasitemia Assessment in relation to DHA and mefloquine blood levels

  • safety, tolerability, acceptability [ Designated as safety issue: Yes ]
    Assessment of adverse events and reporting of tolerability, safety and acceptability


Estimated Enrollment: 70
Study Start Date: October 2005
Estimated Study Completion Date: April 2006
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).

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00243737

Locations
Gabon
Medical Research Unit, Albert Schweitzer Hospital
Lambarene, Gabon
Département de Parasitologie-Mycologie, Faculte de medecine
Libreville, Gabon
Sponsors and Collaborators
Albert Schweitzer Hospital
Mepha Ltd.
Investigators
Principal Investigator: Maryvonne Kombila, Prof Dr Département de Parasitologie-Mycologie, Faculté de médecine
  More Information

No publications provided by Albert Schweitzer Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00243737     History of Changes
Other Study ID Numbers: AM-P 001-2005
Study First Received: October 24, 2005
Last Updated: January 23, 2013
Health Authority: Gabon: Ministry of Health

Keywords provided by Albert Schweitzer Hospital:
Malaria
falciparum
Mefloquine
Artesunate
Artemisinin

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 May 22, 2013