Surveillance of Effectiveness/Safety of Artemether-lumefa... | NCT01228344

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

NCT01228344

Sponsor

Novartis Pharmaceuticals

Status

Completed

Last Update Posted

Apr 7, 2017Actual

Enrollment

324Actual

Phase

Not provided

Conditions

Malaria

Interventions

Artemether-lumefantrine

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2010Actual

Primary Completion Date

Sep 30, 2015Actual

Completion Date

Sep 30, 2015Actual

First Submitted Date

Oct 19, 2010

First Submission Date that Met QC Criteria

Oct 25, 2010

First Posted Date

Oct 26, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 6, 2017

Last Update Posted Date

Apr 7, 2017Actual

Name	Class
Centers for Disease Control and Prevention	FED

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

324Actual

Label	Type	Description	Intervention Names
Artemether-lumefantrine			Other: Artemether-lumefantrine

Name	Type	Description	Arm Group Labels	Other Names
Artemether-lumefantrine	Other		Artemether-lumefantrine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Effectiveness: Resolution of clinical signs and symptoms after artemether-lumefantrine treatment start		4 weeks

Secondary Outcomes

Measure	Description	Time Frame
Adverse event, serious adverse event after artemether-lumefantrine treatment start		4 weeks
Pregnancies after artemether-lumefantrine treatment start		Up to delivery

Other Outcomes

Not provided

Eligibility Module

Eligibility 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:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centers for Disease Control and Prevention,GA		Atlanta	Georgia		United States

Condition Browse Module

MeSH Terms

ID	Term
D008288	Malaria

Ancestor Terms

ID	Term
D011528	Protozoan Infections
D010272	Parasitic Diseases
D007239	Infections
D000096724	Mosquito-Borne Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077611	Artemether, Lumefantrine Drug Combination

Ancestor Terms

ID	Term
D000077549	Artemether
D037621	Artemisinins
D017382	Reactive Oxygen Species
D005609	Free Radicals

Browse Leaves

Not provided

Browse Branches

Not provided