Pleural infection: comparing alteplase with DNase vs alteplase with Tyloxapol

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study compares two intrapleural treatment strategies for pleural infection in adults who have poor drainage after chest tube placement. It measures changes in pleural opacity on chest radiographs, inflammatory markers, drainage volume, hospital stay, and need for surgery, over a 30-day period. The aim is to see if alteplase plus DNase differs in efficacy and safety from alteplase plus Tyloxapol. Data are collected from patients treated at the National University of Malaysia and its collaborating centers.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Inclusion Criteria

1. Adult patient aged ≥ 18 years old
2. Patients with pleural infection (complex parapneumonic effusion or empyema) with poor pleural fluid drainage of ≤ 150 ml after 24 hours of chest drain insertion received either t-PA-DNAse or t-PA/Tyloxapol.
3. Clinical features consistent with pleural infection; fulfilling ≥ 2 of the following characteristics:

   i) Clinical evidence of infection, such as fever and or elevated C-reactive protein (CRP) or total white blood count (TWBC) ii) Complex pleural effusion proven by thoracic ultrasound is defined as the presence of fibrin strands or septations within the pleural cavity iii) Pleural fluid that fulfils at least one of the characteristics:
   * Frank Pus,
   * Exudative type of pleural effusion (according to light's criteria)
   * Gram stain or culture positive
   * Lactate dehydrogenase (LDH) \> 900U/L
   * Acidic with pH \< 7.2
   * Glucose level \< 3.3 mmol/L

Exclusion Criteria:

1. Incomplete data.
2. Medical records that cannot be retrieved.

Where it's running

• National University of Malaysia, Faculty of Medicine
  Cheras, Kuala Lumpur, Malaysia Recruiting

Study contacts

• Principal investigator: Mohamed Faisal Abdul Hamid, MBBS(IIUM) — National University of Malaysia
• Study coordinator: Mohamed Faisal Abdul Hamid, MBBS(IIUM)
• Email: faisal.hamid@hctm.ukm.edu.my
• Phone: 0391455555

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Adding saline irrigation to standard treatment for pleural infections

  This study is testing if adding saline irrigation through a chest tube to standard treatment can help people with pleural infections get better faster and spend less time in the hospital.

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• Once-daily intrapleural enzyme treatment for complicated pleural infections

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  Recruiting at 11 sites Phase 4 University of North Carolina, Chapel Hill · Little Rock, Arkansas and 10 other locations · NCT07095361

• Evaluating saline irrigation for treating retained pleural infections

  This study is testing if adding saline irrigation to standard treatment can help people with retained pleural infections feel better and recover faster.

  Recruiting Phase 2 Beth Israel Deaconess Medical Center · Boston, Massachusetts · NCT06713382

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.