NCT01228344CompletedNot Applicable
Surveillance for the Effectiveness and Safety of Artemether-lumefantrine in Pediatric and Adult Patients With Malaria
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 324
- Locations
- 1
- Primary Endpoint
- Effectiveness: Resolution of clinical signs and symptoms after artemether-lumefantrine treatment start
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Other
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- Not provided
Outcomes
Primary Outcomes
Effectiveness: Resolution of clinical signs and symptoms after artemether-lumefantrine treatment start
Time Frame: 4 weeks
Secondary Outcomes
- Pregnancies after artemether-lumefantrine treatment start(Up to delivery)
- Adverse event, serious adverse event after artemether-lumefantrine treatment start(4 weeks)
Investigators
Study Sites (1)
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