UnknownPhase 2/3

Dornase Alfa and Urokinase for Kids With Pleural Empyema

Italy94 participantsStarted 2007-10

Plain-language summary

The purpose of this study is to determine whether intrapleural treatment with Dornase alfa plus Urokinase improves clinical outcome compared to Urokinase alone in children with complicated parapneumonic effusions

Who can participate

Age range

1 Year – 16 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age \> 1 year and \< 16 years * Respiratory infection (pneumonia or lung abscess) * Effusion occupying at least 1/3 of hemithorax on chest X-ray * Complicated effusion (presence of at least one of the following): * Hyperechoic pleural fluid on chest US scan * Loculated collection on chest US or CT scan * Purulent pleural fluid * Positive culture or Gram stain on pleural fluid Exclusion Criteria: * Non parapneumonic effusion * Immunodeficiency * Neurological impairment * Suspected or proven allergy to Urokinase or Dornase alfa * Suspected or documented bronchopleural fistula * Impaired coagulation (INR\>2), haemorrhage, high risk for bleeding * Thoracic surgical procedure (e.g. thoracoscopy, mini-thoracotomy) already performed * Chest drain inserted since 6 or more days

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Duration of hospital stay

Timeframe: From beginning of intrapleural treatment

Need for additional surgical procedures

Timeframe: 3 months

Trial details

NCT IDNCT00502632

SponsorAzienda Ospedaliera di Padova

Sponsor typeOTHER

Study typeINTERVENTIONAL

Contact for this trial

PierGiorgio Gamba, MD

+39 049 821 3683 piergiorgio.gamba@unipd.it

View on ClinicalTrials.gov More Pleural Empyema trials

Who can participate

Age range

1 Year – 16 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.