Empyema Treated With tPA & DNAse | NCT01862458

Studies
Empyema Treated With tPA & DNAse

NCT01862458

Sponsor

Children's Mercy Hospital Kansas City

Status

Withdrawn

Last Update Posted

Jan 28, 2016Estimated

Enrollment

0Actual

Phase

Phase 3

Conditions

Empyema

Interventions

tPA alone
tPA plus dornase

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

ID	Type	Description	Link
12120552	Other Identifier	Children's Mercy Hospital

Status Module

Record Verification Date

Jan 2016

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

funding difficulty

Expanded Access Info

Start Date

Jan 2016

Primary Completion Date

Jan 2016Actual

Completion Date

Jan 2016Actual

First Submitted Date

May 17, 2013

First Submission Date that Met QC Criteria

May 22, 2013

First Posted Date

May 24, 2013Estimated

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 27, 2016

Last Update Posted Date

Jan 28, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Shawn St. Peter, Assoc Prof, Children's Mercy Hospital Kansas CityPrincipal Investigator

Lead Sponsor

Children's Mercy Hospital Kansas CityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

Description Module

Brief Summary

The objective of this study is to scientifically evaluate a new substrate for fibrinolysis compared to our standard tPA.

The hypothesis, driven by a recent prospective trial, is that tPA may benefit from the addition of DNAse.

The primary outcome variable between the two techniques will be length of hospitalization after initiation of treatment.

Detailed Description

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

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
tPA alone	Active Comparator	tPA alone used to treat empyema	Biological: tPA alone
tPA plus dornase	Experimental	tPA plus dornase used to treat empyema	Biological: tPA plus dornase

Interventions

Name	Type	Description	Arm Group Labels	Other Names
tPA alone	Biological		tPA alone
tPA plus dornase

Measure	Description	Time Frame
Length of stay		3 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients less than 18 years of age requiring an intervention for empyema by one of the following:

Septation or loculation seen on ultrasound or computed tomography or
Greater than 10,000 white blood cells identified on pleural tap

Exclusion Criteria:

Immunodeficiency process
Secondary diagnosis or condition that will keep them in the hospital beyond the empyema
Existing contraindications to chest tube
Documented allergy to one of the study medications

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

17 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Shawn D St. Peter, MD	Children's Mercy Hospital and Clinics	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Children's Mercy Hospital		Kansas City	Missouri	64108	United States

Condition Browse Module

MeSH Terms

ID	Term
D004653	Empyema

Ancestor Terms

ID	Term
D013492	Suppuration
D007239	Infections
D007249	Inflammation
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided