CompletedPhase 4

Management of Pleural Space Infections

United States26 participantsStarted 2019-04-01

Plain-language summary

Currently, there is no high-quality evidence comparing the clinical outcomes and cost effectiveness of surgical drainage combined with antibiotics versus dual-agent intrapleural fibrinolytic therapy (IPFT) catheter drainage of pleural space infections with concomitant antibiotic therapy. The absence of comparative data is a challenge for surgical and medical services in clinical decision-making for this common and morbid condition. This is a pilot study comparing surgical drainage of the pleural space in complex pleural effusions to bedside chest tube drainage using dual agent IPFT with the intent to inform on study algorithm and endpoint performance in anticipation of a multi-institutional randomized clinical trial.

Who can participate

Age range18 Years

SexALL

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 \>18 years * Clinical presentation compatible with pleural infection (fever or leukocytosis, elevated procalcitonin, elevated C-reactive protein (CRP)) * Pleural fluid requiring drainage that is either: * Macroscopically purulent or * Positive on culture for bacterial infection or * Positive for bacteria on gram stain or * Lactate dehydrogenase (LDH) \> 1000 IU/L or * Glucose \<40 mg/dL Exclusion Criteria: * Age \<18 years * Unable to give consent (No surrogate consent of legally authorized representatives allowed for this study) * Not proficient in English * History of prior ipsilateral empyema * Has known sensitivity to DNase or alteplase * History of intracranial hemorrhage or acute intracranial hemorrhage * History of stroke, hemorrhage, or trauma within the last 3 months * Has had prior surgery on the side of the pleural infection * Patients who are pregnant or lactating * Expected survival less than 6 months from a different pathology to this pleural infection based on clinical judgment * Has a tunneled pleural catheter in place * Patients on anticoagulation that cannot be interrupted for surgical intervention * Patients with known or suspected malignant pleural effusion * Patients with renal failure (Creatinine clearance \<30) * Prior history of or concern for chylothorax or pseudochylothorax * Vulnerable populations: prisoners

What they're measuring

Feasibility of the proposed study algorithm as measured by percent of subjects enrolled to study completion, percent of subjects randomized but did not complete the study, and percent of health care professional protocol deviation

Timeframe: From patient identification to 1 year post discharge

Subject identification and accrual as measured by the percent of patients not screened and randomized and the time to accrual of 20 patients of the number of patients accrued in one year

Timeframe: From patient identification to 1 year post discharge

Trial details

NCT IDNCT03873766

SponsorSwedish Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-03-11

View on ClinicalTrials.gov More Empyema, Pleural trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

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

What they're measuring

Timeframe: From patient identification to 1 year post discharge

Subject identification and accrual as measured by the percent of patients not screened and randomized and the time to accrual of 20 patients of the number of patients accrued in one year

Timeframe: From patient identification to 1 year post discharge