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

Novartis

Status: Completed

Conditions: Malaria

Treatments: Other: Artemether-lumefantrine

Study type: Observational

Funder types: Industry; Other U.S. Federal agency

Identifiers

NCT01228344

CCOA566A2424

Details and patient eligibility

About

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.

Enrollment: 324 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

324 participants in 1 patient group

Artemether-lumefantrine

Treatment:

Other: Artemether-lumefantrine