Artemether/Lumefantrine and Vivax Malaria | NCT01625871

Studies
Artemether/Lumefantrine and Vivax Malaria

NCT01625871

Sponsor

University of Khartoum

Status

Completed

Last Update Posted

Jan 17, 2013Estimated

Enrollment

38Actual

Phase

Phase 3

Conditions

Vivax Malaria

Interventions

tablets artemether/lumefantrine

Countries

Sudan

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2013

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

Sep 2011

Primary Completion Date

Sep 2012Actual

Completion Date

Sep 2012Actual

First Submitted Date

Jun 17, 2012

First Submission Date that Met QC Criteria

Jun 19, 2012

First Posted Date

Jun 22, 2012Estimated

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

Jan 16, 2013

Last Update Posted Date

Jan 17, 2013Estimated

Name	Class
University of Kassala, Sudan	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

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

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

38Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
artemether-lumefantrine	Experimental	tablets (containing 20mg artemether and 120 mg lumefantrine) for three days	Drug: tablets artemether/lumefantrine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
tablets artemether/lumefantrine	Drug	six doses of oral tablets of artemether/lumefantrine	artemether-lumefantrine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The cure rate	The proportion of the cure patients	28 days

Secondary Outcomes

Measure	Description	Time Frame
Fever clearance time	The time for fever clearance	28 days
Parasite clearance time	The time for the parasite to clear	28 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with vivax malaria

Exclusion Criteria:

severe malaria
pregnancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

80 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Kassala		Kassala	Kassala	249	Sudan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19818172	Background	Makanga M, Krudsood S. The clinical efficacy of artemether/lumefantrine (Coartem). Malar J. 2009 Oct 12;8 Suppl 1(Suppl 1):S5. doi: 10.1186/1475-2875-8-S1-S5.
23217037	Derived	Abdallah TM, Ali AA, Bakri M, Gasim GI, Musa IR, Adam I. Efficacy of artemether-lumefantrine as a treatment for uncomplicated Plasmodium vivax malaria in eastern Sudan. Malar J. 2012 Dec 5;11:404. doi: 10.1186/1475-2875-11-404.

Type	Date	Date Unknown
Release	Mar 5, 2013
Reset	Apr 15, 2013
Release	Apr 19, 2013
Reset	May 23, 2013
Release	May 27, 2013
Reset	May 28, 2013

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Mar 5, 2013			Apr 15, 2013
Apr 19, 2013

ID	Term
D016780	Malaria, Vivax
D008288	Malaria

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

ID	Term
D037621	Artemisinins
D017382	Reactive Oxygen Species
D005609	Free Radicals
D007287	Inorganic Chemicals

ID	Term
D000077549	Artemether
D000078102	Lumefantrine