Efficacy, Safety and Pharmacokinetic of ArtequinTM P. Falciparum Malaria

NCT00243737 | Completed Phase 2

• 1 other identifier: AM-P 001-2005
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Malaria

Keywords

Malaria; falciparum; Mefloquine; Artesunate; Artemisinin

Outcome Measures

Primary Outcomes (1)

• Efficacy, Proportion of patients cured on day 28

Secondary Outcomes (3)

• 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

• safety, tolerability, acceptability

Interventions

Artesunate-Mefloquine DRUG

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Albert Schweitzer Hospital: lead
• Mepha Ltd.: collaborator

Study Sites (2)

Medical Research Unit, Albert Schweitzer Hospital

Lambaréné, Gabon

Location

Département de Parasitologie-Mycologie, Faculte de medecine

Libreville, Gabon

Location

Related Publications (1)

• Bouyou-Akotet MK, Ramharter M, Ngoungou EB, Mamfoumbi MM, Mihindou MP, Missinou MA, Kurth F, Belard S, Agnandji ST, Issifou S, Heidecker JL, Trapp S, Kremsner PG, Kombila M. Efficacy and safety of a new pediatric artesunate-mefloquine drug formulation for the treatment of uncomplicated falciparum malaria in Gabon. Wien Klin Wochenschr. 2010 Mar;122(5-6):173-8. doi: 10.1007/s00508-010-1317-1.

  PMID: 20361381 DERIVED

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

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

Study Officials

• Maryvonne Kombila, Prof Dr

  Département de Parasitologie-Mycologie, Faculté de médecine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 24, 2005
• First Posted: October 25, 2005
• Study Start: October 1, 2005
• Study Completion: April 1, 2006
• Last Updated: January 24, 2013

Record last verified: 2013-01

Locations

GA (2)