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Surveillance of Effectiveness/Safety of Artemether-lumefantrine in Patients With Malaria

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01228344
First received: October 19, 2010
Last updated: April 4, 2016
Last verified: April 2016

October 19, 2010
April 4, 2016
May 2010
May 2016   (final data collection date for primary outcome measure)
Effectiveness: Resolution of clinical signs and symptoms after artemether-lumefantrine treatment start [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01228344 on ClinicalTrials.gov Archive Site
  • Adverse event, serious adverse event after artemether-lumefantrine treatment start [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Pregnancies after artemether-lumefantrine treatment start [ Time Frame: Up to delivery ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Surveillance of Effectiveness/Safety of Artemether-lumefantrine in Patients With Malaria
Surveillance for the Effectiveness and Safety of Artemether-lumefantrine in Pediatric and Adult Patients With Malaria
The purpose of this study is to describe the pediatric and adult patients (U.S. and foreign residents) diagnosed with malaria and treated with artemether-lumefantrine with regard to their demographics, including evaluation of their malaria immune status, treatment effectiveness, prior and concomitant medication use, and the occurrence of adverse events in association with artemether-lumefantrine treatment, based on the information collected in the CDC Malaria Case Surveillance Report Form.
Not Provided
Observational
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Non-Probability Sample
Any male or female infant, child or adult patient diagnosed with malaria who received artemether-lumefantrine and was reported to the Centers for Disease Control, Atlanta GA.
Malaria
Other: Artemether-lumefantrine
Artemether-lumefantrine
Intervention: Other: Artemether-lumefantrine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
3000
Not Provided
May 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Any male or female infant, child or adult patient diagnosed with malaria who received artemether-lumefantrine and was reported to the CDC. Malaria may be clinically suspected or confirmed (microscopically, and/or by polymerase chain reaction [PCR], and/or rapid diagnostic test [RDT]).

Exclusion Criteria:

Both
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01228344
CCOA566A2424
Not Provided
Not Provided
Not Provided
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Centers for Disease Control and Prevention
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP