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

This study has been completed.
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals ) Identifier:
First received: October 19, 2010
Last updated: April 6, 2017
Last verified: April 2017
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
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:

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


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.

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
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 identifier: NCT01228344

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
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals Identifier: NCT01228344     History of Changes
Other Study ID Numbers: CCOA566A2424
Study First Received: October 19, 2010
Last Updated: April 6, 2017

Keywords provided by Novartis:

Additional relevant MeSH terms:
Protozoan Infections
Parasitic Diseases
Artemether-lumefantrine combination
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antifungal Agents
Antiplatyhelmintic Agents
Anthelmintics processed this record on May 22, 2017