Efficacy, Safety and Tolerability of Co-artemether in Non-immune Travelers
This study has been completed.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
First received: October 4, 2005
Last updated: April 25, 2012
Last verified: April 2012
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
Acute Uncomplicated P. Falciparum Malaria
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||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
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:
| Study Completion Date:
| Primary Completion Date:
||August 2005 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years and older (Adult, Senior)
|Genders Eligible for Study:
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.
Other protocol inclusion/exclusion criteria may apply
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00233337
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 4, 2005
||April 25, 2012
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:
ClinicalTrials.gov processed this record on July 21, 2016