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
1 other identifier
observational
324
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2010
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 19, 2010
CompletedFirst Posted
Study publicly available on registry
October 26, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2015
CompletedApril 7, 2017
April 1, 2017
5.4 years
October 19, 2010
April 6, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Effectiveness: Resolution of clinical signs and symptoms after artemether-lumefantrine treatment start
4 weeks
Secondary Outcomes (2)
Adverse event, serious adverse event after artemether-lumefantrine treatment start
4 weeks
Pregnancies after artemether-lumefantrine treatment start
Up to delivery
Study Arms (1)
Artemether-lumefantrine
Interventions
Eligibility Criteria
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.
You may qualify if:
- 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 \[RDT\]).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centers for Disease Control and Prevention,GA
Atlanta, Georgia, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 19, 2010
First Posted
October 26, 2010
Study Start
May 1, 2010
Primary Completion
September 30, 2015
Study Completion
September 30, 2015
Last Updated
April 7, 2017
Record last verified: 2017-04