Empyema Treated With tPA & DNAse

Recruiting in Palo Alto (17 mi)

Overseen by Shawn D St. Peter, MD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Children's Mercy Hospital Kansas City

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Shawn D St. Peter, MD

Principal Investigator

Children's Mercy Hospital and Clinics

Eligibility Criteria

Inclusion Criteria

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

Treatment Details

Interventions

• tPA alone (Fibrinolytic Agent)
• tPA plus dornase (Fibrinolytic Agent)

Participant Groups

Group I: tPA plus dornase Experimental Treatment 1 Intervention

tPA plus dornase used to treat empyema

Group II: tPA alone Active Control 1 Intervention

tPA alone used to treat empyema

Who Is Running the Clinical Trial?

Children's Mercy Hospital Kansas City

Lead Sponsor

Trials

261

Recruited

941,000+

Dr. Alejandro Quiroga

Children's Mercy Hospital Kansas City

Chief Executive Officer

MD from Universidad Del Rosario, MBA

Dr. Doug Blowey

Children's Mercy Hospital Kansas City

Chief Medical Officer since 2023

MD from University of Kansas