Antiseptic Irrigation for Pleural Infection

Status Completed

Clinical Trial Summary

The antiseptic povidone-iodine can safely be instilled into the pleural for the purpose of pleurodesis. Pleural irrigation with antiseptics is used in adults with open drainage for chronic empyema and has been described in the acute management of paediatric pleural infection. This study will investigate the safety and usefulness of povidone-iodine pleural irrigation in 15 eligible patients recruited to the Pleural Infection Cohort Study (PICS) with acute pleural infection. A matched control group will be used and will be composed of 15 patients previously recruited to PICS without receiving povidone-iodine pleural irrigation.

Clinical Trial Description

Pleural infection is a condition that requires hospitalization for management and is associated with significant in-hospital morbidity and mortality. Predictors of poor outcome include advancing age, poor nutrition, hospital-acquired infection and impaired renal function. Medical management is centred on appropriate antibiotic treatment and fluid drainage usually by the means of an intercostal tube. Up to 30% of patients fail medical treatment and referred for surgery. A recent systematic review of adults patient with pleural infection has shown that the demographics of patients with pleural infection are different in patients from high-income vs lower income countries; the latter being of younger age and lower comorbidity burden. However, the results of the review did not show significant differences in patient outcomes. The same systematic review pointed to the need for more data from patients residing in lower income countries given that the majority of data is contributed by studies from higher income countries. This platform study aims to prospectively investigate the incidence of pleural infection in a large tertiary centre gathering demographic and clinical data about patients recruited. In addition, the study will examine the different treatment offered and how this related to in-hospital outcomes (length of hospital stay, rate of referral to surgery and mortality). The study will be designed as a modified trial within cohort (TwiC) study. PICS will primarily aim to recruit patients prospectively to gather clinical and demographic data on patients admitted with pleural infection in addition to clinical data on tests performed and treatments received as part of the standard care. The in-patient outcomes will be recorded at the time of discharge data or death, whichever is earlier. Within the TWIC design, PICS will be a platform for recruiting patients to interventional trials for eligible patients within the cohort. As a planned sub-study, pleural antiseptics will be trialed within a subset of patients enrolled. The antiseptic povidone-iodine can safely be instilled into the pleural for the purpose of pleurodesis. Pleural irrigation with antiseptics is used in adults with open drainage for chronic empyema and has been described in the acute management of paediatric pleural infection. This sub-study will investigate the safety and usefulness of povidone-iodine pleural irrigation in 15 eligible adult patients recruited to PICS with acute pleural infection. A matched control group will be used and will be composed of 15 patients previously recruited to PICS without receiving povidone-iodine pleural irrigation. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04761133
Study type	Interventional
Source	Alexandria University
Contact
Status	Completed
Phase	Phase 1
Start date	March 4, 2021
Completion date	August 15, 2021

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.