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

April 6, 2017 updated by: Novartis Pharmaceuticals

Surveillance for the Effectiveness and Safety of Artemether-lumefantrine in Pediatric and Adult 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

324

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States
        • Centers for Disease Control and Prevention,GA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Any male or female infant, child or adult patient diagnosed with malaria who received artemether-lumefantrine and was reported to the Centers for Disease Control, Atlanta GA.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Artemether-lumefantrine
Other: Artemether-lumefantrine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Effectiveness: Resolution of clinical signs and symptoms after artemether-lumefantrine treatment start
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse event, serious adverse event after artemether-lumefantrine treatment start
Time Frame: 4 weeks
4 weeks
Pregnancies after artemether-lumefantrine treatment start
Time Frame: Up to delivery
Up to delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Collaborators

Centers for Disease Control and Prevention

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2010

Primary Completion (Actual)

September 30, 2015

Study Completion (Actual)

September 30, 2015

Study Registration Dates

First Submitted

October 19, 2010

First Submitted That Met QC Criteria

October 25, 2010

First Posted (Estimate)

October 26, 2010

Study Record Updates

Last Update Posted (Actual)

April 7, 2017

Last Update Submitted That Met QC Criteria

April 6, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCOA566A2424

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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