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

Malaria Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01228344
• Other study ID #: CCOA566A2424
• Status: Completed
• Phase: N/A
• First received: October 19, 2010
• Last updated: April 6, 2017
• Start date: May 1, 2010
• Est. completion date: September 30, 2015

Study information

• Verified date: April 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 324
• Est. completion date: September 30, 2015
• Est. primary completion date: September 30, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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:

Related Conditions & MeSH terms

• Malaria

Intervention

Other:
• Artemether-lumefantrine

Locations

Country	Name	City	State
United States	Centers for Disease Control and Prevention,GA	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals	Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness: Resolution of clinical signs and symptoms after artemether-lumefantrine treatment start		4 weeks
Secondary	Adverse event, serious adverse event after artemether-lumefantrine treatment start		4 weeks
Secondary	Pregnancies after artemether-lumefantrine treatment start		Up to delivery