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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by Novartis
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01228344
First received: October 19, 2010
Last updated: November 27, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention
Malaria
Other: Artemether-lumefantrine

Study Type: Observational
Official Title: Surveillance for the Effectiveness and Safety of Artemether-lumefantrine in Pediatric and Adult Patients With Malaria

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Effectiveness: Resolution of clinical signs and symptoms after artemether-lumefantrine treatment start [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse event, serious adverse event after artemether-lumefantrine treatment start [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Pregnancies after artemether-lumefantrine treatment start [ Time Frame: Up to delivery ] [ Designated as safety issue: No ]

Estimated Enrollment: 3000
Study Start Date: May 2010
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Artemether-lumefantrine Other: Artemether-lumefantrine

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01228344

Contacts
Contact: Novartis Pharmaceuticals 862-778-8300

Locations
United States, Georgia
Centers for Disease Control and Prevention,GA Recruiting
Atlanta, Georgia, United States
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01228344     History of Changes
Other Study ID Numbers: CCOA566A2424
Study First Received: October 19, 2010
Last Updated: November 27, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Artemether-lumefantrine
demographics
malaria

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases
Artemether
Artemisinins
Lumefantrine
Artemether-lumefantrine combination
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Coccidiostats
Schistosomicides
Antiplatyhelmintic Agents
Anthelmintics

ClinicalTrials.gov processed this record on August 19, 2014