NCT01862458

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 17, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 24, 2013

Completed
2.6 years until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

January 28, 2016

Status Verified

January 1, 2016

Enrollment Period

Same day

First QC Date

May 17, 2013

Last Update Submit

January 27, 2016

Conditions

Empyema

Keywords

empyematPAdornase

Outcome Measures

Primary Outcomes (1)

  • Length of stay

    3 weeks

Study Arms (2)

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

tPA aloneBIOLOGICAL
tPA alone
tPA plus dornaseBIOLOGICAL
tPA plus dornase

Eligibility Criteria

AgeUp to 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

MeSH Terms

Conditions

Empyema

Condition Hierarchy (Ancestors)

SuppurationInfectionsInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Shawn D St. Peter, MD

    Children's Mercy Hospital and Clinics

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc Prof

Study Record Dates

First Submitted

May 17, 2013

First Posted

May 24, 2013

Study Start

January 1, 2016

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

January 28, 2016

Record last verified: 2016-01

Locations

US(1)