Skip to content

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01228344
Enrollment
324
Registered
2010-10-26
Start date
2010-05-01
Completion date
2015-09-30
Last updated
2017-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malaria

Keywords

Artemether-lumefantrine, demographics, malaria

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.

Interventions

OTHERArtemether-lumefantrine

Sponsors

Centers for Disease Control and Prevention
CollaboratorFED
Novartis Pharmaceuticals
Lead SponsorINDUSTRY

Study design

Observational model
OTHER
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
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

* NA

Design outcomes

Primary

MeasureTime frame
Effectiveness: Resolution of clinical signs and symptoms after artemether-lumefantrine treatment start4 weeks

Secondary

MeasureTime frame
Adverse event, serious adverse event after artemether-lumefantrine treatment start4 weeks
Pregnancies after artemether-lumefantrine treatment startUp to delivery

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026