We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01228344
First Posted: October 26, 2010
Last Update Posted: April 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  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
Study Design: Observational Model: Other
Time Perspective: Other
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 ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • Effectiveness: Resolution of clinical signs and symptoms after artemether-lumefantrine treatment start [ Time Frame: 4 weeks ]

Secondary Outcome Measures:
  • Adverse event, serious adverse event after artemether-lumefantrine treatment start [ Time Frame: 4 weeks ]
  • Pregnancies after artemether-lumefantrine treatment start [ Time Frame: Up to delivery ]

Enrollment: 324
Actual Study Start Date: May 1, 2010
Study Completion Date: September 30, 2015
Primary Completion Date: September 30, 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Artemether-lumefantrine Other: Artemether-lumefantrine

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01228344


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

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01228344     History of Changes
Other Study ID Numbers: CCOA566A2424
First Submitted: October 19, 2010
First Posted: October 26, 2010
Last Update Posted: April 7, 2017
Last Verified: April 2017

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Artemether-lumefantrine
demographics
malaria

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