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CompletedNCT01228344Updated Apr 7, 2017

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

An observational study in Malaria, sponsored by Novartis Pharmaceuticals. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2017-04-07.

Sponsored by Novartis Pharmaceuticals · Observational

Study type
Observational
Model
Other
Time perspective
Other
Enrollment
324
Sex
All
01

Study 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.

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Conditions studied

  • Malaria

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Keywords

  • Artemether-lumefantrine
  • demographics
  • malaria
03

In context

Malaria

1,299 studies on the registry are indexed under Malaria; 86 are open to participants now.

This study's enrollment of 324 is below the median of 600 across 218 observational studies indexed under Malaria.

Browse Malaria studies →

Lead sponsor

Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.

Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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

Exclusion Criteria:

  • NA
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Study design

Observational model
Other
Time perspective
Other
Enrollment
324 participants (actual)

Groups and cohorts

  • Artemether-lumefantrine

    Other: Artemether-lumefantrine

Interventions

  • OtherArtemether-lumefantrine
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What researchers measure

Primary outcomes

  1. Effectiveness: Resolution of clinical signs and symptoms after artemether-lumefantrine treatment start

    Time frame: 4 weeks

Secondary outcomes

  1. Adverse event, serious adverse event after artemether-lumefantrine treatment start

    Time frame: 4 weeks

  2. Pregnancies after artemether-lumefantrine treatment start

    Time frame: Up to delivery

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Study locations

1 site
  • Centers for Disease Control and Prevention,GA
    Atlanta, Georgia, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 7, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01228344
Lead sponsor
Novartis Pharmaceuticals
Collaborators
Centers for Disease Control and Prevention
Responsible party
Sponsor
First posted
Oct 26, 2010
Start date
May 1, 2010
Primary completion
Sep 30, 2015
Completion
Sep 30, 2015
Last update
Apr 7, 2017

Study contacts

Novartis Pharmaceuticals
study director · Novartis Pharmaceuticals
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

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