Surveillance of Effectiveness/Safety of Artemether-lumefantrine in Patients With Malaria
Completed
- Conditions
- Malaria
- Interventions
- Other: Artemether-lumefantrine
- Registration Number
- NCT01228344
- Lead Sponsor
- Novartis Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 324
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
- NA
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Artemether-lumefantrine Artemether-lumefantrine -
- Primary Outcome Measures
Name Time Method Effectiveness: Resolution of clinical signs and symptoms after artemether-lumefantrine treatment start 4 weeks
- Secondary Outcome Measures
Name Time Method Pregnancies after artemether-lumefantrine treatment start Up to delivery Adverse event, serious adverse event after artemether-lumefantrine treatment start 4 weeks
Trial Locations
- Locations (1)
Centers for Disease Control and Prevention,GA
🇺🇸Atlanta, Georgia, United States