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OpenTrials
Completed

NCT Number: NCT01228344

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

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.

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Key information

Conditions

Malaria Infections Mosquito-Borne Diseases Parasitic Diseases Protozoan Infections Vector Borne Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Centers for Disease Control and Prevention,GA

Atlanta, Georgia, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Artemether-lumefantrine

Other

Primary outcomes

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

    Time frame: 4 weeks

Secondary outcomes

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

    Time frame: 4 weeks

  2. Pregnancies after artemether-lumefantrine treatment start

    Time frame: Up to delivery

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Collaborators

  • Centers for Disease Control and Prevention

Registry information

Official study title

Surveillance for the Effectiveness and Safety of Artemether-lumefantrine in Pediatric and Adult Patients With Malaria

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Oct 26, 2010
Registry last updated
Apr 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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