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

Novartis Pharmaceuticals324 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

324

Conditions

Malaria

Interventions

Artemether-lumefantrineOTHER

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Centers for Disease Control and Prevention,GA

Atlanta, Georgia, United States

Outcomes

Primary Outcomes

Effectiveness: Resolution of clinical signs and symptoms after artemether-lumefantrine treatment start

Time frame: 4 weeks

Secondary Outcomes

Adverse event, serious adverse event after artemether-lumefantrine treatment start

Time frame: 4 weeks

Pregnancies after artemether-lumefantrine treatment start

Time frame: Up to delivery

Data from ClinicalTrials.gov

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