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

NCT ID: NCT01228344

Last Updated: 2017-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

324 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-05-01

Study Completion Date

2015-09-30

Brief Summary

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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

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Conditions

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Malaria

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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Artemether-lumefantrine

Artemether-lumefantrine

Intervention Type OTHER

Interventions

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Artemether-lumefantrine

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centers for Disease Control and Prevention

FED

Sponsor Role collaborator

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Centers for Disease Control and Prevention,GA

Atlanta, Georgia, United States

Site Status

Countries

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United States

Other Identifiers

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CCOA566A2424

Identifier Type: -

Identifier Source: org_study_id

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