Efficacy, Safety and Tolerability of Co-artemether in Non-immune Travelers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00233337
First received: October 4, 2005
Last updated: April 25, 2012
Last verified: April 2012
  Purpose

This study will assess the safety and efficacy of co-artemether in the treatment of acute uncomplicated P. falciparum malaria in returning non-immune travellers

THIS STUDY IS NOT ENROLLING PATIENTS IN THE UNITED STATES


Condition Intervention Phase
Acute Uncomplicated P. Falciparum Malaria
Drug: Co-artemether
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-label, Multi-center, Non-comparative Efficacy, Safety, and Tolerability Study of Co-artemether in the Treatment of Acute Uncomplicated Malaria in Non-immune Patients

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Proportion of patients free of parasites in the blood after 28 days.

Secondary Outcome Measures:
  • Proportion of patients free of parasites in the blood after 7 days
  • Time to clearance of fever
  • Time to clearance of parasites in the blood
  • Proportion of patients with presence of sexual forms of the parasite in the blood (gametocytes);
  • Hematology and biochemistry

Study Start Date: May 2001
Study Completion Date: August 2005
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

Patients were eligible for inclusion if they met all of the following criteria:

  • Male or female aged 18 or older (prior to Amendment 1: more than 2 years old)
  • Non-immune patients suffering from acute uncomplicated P. falciparum malaria, or mixed infection including P. falciparum, with parasitemia of less than or equal to 2% asexual P.falciparum parasites, confirmed by microscopy using Giemsa-stained thick film.
  • Non-immune patients were regarded as those who had not spent the first five years of their life, nor the last five years in a malaria endemic area, and did not have acute P. falciparum malaria diagnosed during those past five years.
  • Non-immune patients who had received prophylaxis with anti-malarials (excluding halofantrine) were included only if clear progression of acute P. falciparum infection was documented.
  • Female patients were eligible to participate in the study if they were of non-childbearing potential or had a negative pregnancy test (urine or serum) at screening, and using an acceptable contraceptive method
  • Patients, who had been informed of the study procedures and medication, and had given written informed consent and were willing to comply with the study protocol.

Exclusion Criteria:

  • Patients were to be excluded from participation if they met any of the following criteria:

    • Known hypersensitivity to artemether or lumefantrine
    • Signs/symptoms indicative of severe/complicated malaria according to the WHO classification (e.g. cerebral malaria, see Post-text supplement 1)
    • Treatment with artemisinin derivatives within the previous 7 days
    • Concurrent administration of other treatment / prophylaxis for malaria
    • Concurrent administration of medications with potential hemolytic effects
    • Patients taking any drug metabolized by cytochrome isoenzymes CYP3A4 or CYP2D6
    • Received any other investigational drugs in the last 4 weeks before entry into the study
    • Severe cardiac impairment (i.e. evidence of existing cardiac conduction defect or overt symptoms of cardiac dysfunction or abnormalities of baseline ECG not associated with acute malaria); clinically relevant bradycardia or congestive cardiac failure with reduced left ventricular ejection fraction; pre-existing prolongation of the QT interval; history of symptomatic cardiac arrhythmias
    • Having received halofantrine or any other drug known to influence cardiac function within 4 weeks prior to Screening visit or taking other drugs that are known to prolong the QT interval, including class IA and III antiarrhythmics, neuroleptics, antidepressive agents, certain antibiotics (including some macrolides, fluoroquinolones, imidazole, and triazole antifungal agents), certain non-sedating antihistaminics (terfenadine, astemizole) and cisapride
    • History of splenectomy
    • Clinically significant abnormal baseline hematology (not associated with acute malaria) or clinical chemistry parameters, including evidence of hepatic or renal impairment, known disturbances of electrolyte balance e.g. hypokalemia or hypomagnesaemia
    • Serious, uncontrolled disease (including serious psychological disorders) likely to interfere with the study, or concomitant disease which could mask the response to treatment
    • Unlikely, in the opinion of the investigator, to complete the dosing or follow-up periods, or who have evidence of alcohol, drug or solvent abuse.
    • Women who are pregnant, lactating or of childbearing potential and not using an acceptable contraceptive method were also excluded.

Other protocol inclusion/exclusion criteria may apply

  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: NCT00233337

Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Chair: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00233337     History of Changes
Other Study ID Numbers: CCOA566A2401
Study First Received: October 4, 2005
Last Updated: April 25, 2012
Health Authority: Switzerland: Swissmedic
Germany: Federal Institute for Drugs and Medical Devices
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Italy: The Italian Medicines Agency
Netherlands: Medicines Evaluation Board (MEB)
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos

Keywords provided by Novartis:
Malaria, non-immune travelers

Additional relevant MeSH terms:
Malaria
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases
Artemether
Artemisinins
Artemether-lumefantrine combination
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Coccidiostats
Schistosomicides
Antiplatyhelmintic Agents
Anthelmintics

ClinicalTrials.gov processed this record on July 28, 2014