WithdrawnNCT01862458Updated Jan 28, 2016

Empyema Treated With tPA & DNAse

A Phase 3 interventional study of tPA alone and tPA plus dornase in Empyema, sponsored by Children's Mercy Hospital Kansas City. Withdrawn at 1 site in United States. Open to participants aged Up to 17 Years. Per ClinicalTrials.gov, last updated 2016-01-28.

Sponsored by Children's Mercy Hospital Kansas City · Phase 3, Interventional, and Treatment

Why this study was withdrawn

funding difficulty

Phase: Phase 3
Study type: Interventional
Enrollment: 0
Allocation: Randomized
Ages: Up to 17 Years
Sex: All

Study 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.

Conditions studied

Empyema

Browse trials for

Empyema 38

Keywords

empyema
tPA
dornase

In context

Empyema

38 studies on the registry are indexed under Empyema; 11 are open to participants now.

Browse Empyema studies →

Lead sponsor

Children's Mercy Hospital Kansas City is the lead sponsor of 210 studies on the registry; 20 are open to participants now.

Of its 18 completed or terminated interventional studies of FDA-regulated products, 14 (78%) have results posted.

Browse Children's Mercy Hospital Kansas City studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: Up to 17 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

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

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication: A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Care provider, Investigator)
Enrollment: 0 participants (actual)

Study arms

Active comparator
tPA alone
tPA alone used to treat empyema
Biological: tPA alone
Experimental
tPA plus dornase
tPA plus dornase used to treat empyema
Biological: tPA plus dornase

Interventions

BiologicaltPA alone
BiologicaltPA plus dornase

What researchers measure

Primary outcomes

Length of stay
Time frame: 3 weeks

Study locations

1 site

Children's Mercy Hospital
Kansas City, Missouri 64108, United States

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2016, a primary completion of Jan 2016 and a completion of Jan 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered: May 17, 2013
First posted: May 24, 2013
Start: Jan 2016
Primary completionActual: Jan 2016
CompletionActual: Jan 2016
Last update: Jan 28, 2016

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Jan 28, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01862458
Lead sponsor: Children's Mercy Hospital Kansas City
Responsible party: Shawn St. Peter (Assoc Prof, Children's Mercy Hospital Kansas City) — Principal investigator
First posted: May 24, 2013
Start date: Jan 2016
Primary completion: Jan 2016
Completion: Jan 2016
Last update: Jan 28, 2016

Study contacts

Shawn D St. Peter, MD

principal investigator · Children's Mercy Hospital and Clinics

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.

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Discussion

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