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

This study is currently recruiting participants.
Verified November 2012 by Novartis
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
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
History of Changes
  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:

MedlinePlus related topics: Malaria
U.S. FDA Resources

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
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
Centers for Disease Control and Prevention
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 May 16, 2013