Antiseptic Irrigation for Pleural Infection

Pleural Infection Clinical Trial

Official title:

Antiseptic Pleural Irrigation for Patients With Pleural Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04761133
• Other study ID #: 04/24/11/10/2020
• Status: Completed
• Phase: Phase 1
• Start date: March 4, 2021
• Est. completion date: August 15, 2021

Study information

• Verified date: August 2022
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: August 15, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All adult patients admitted to hospital with pleural infection and had a chest tube inserted for treatment of the infection. Pleural infection will be defined by the presence of one of the following: a) the presence of pus in the pleural space; b) positive pleural fluid gram stain or culture; or c) pleural fluid pH < 7.2 or pleural fluid glucose < 40 mg/dL in the setting of acute respiratory infection.

• Pleural collection is unilocular on pre-drainage imaging. Presence of septations on ultrasound examination is allowed.

Exclusion Criteria:

• Known or suspected thyroid disease

• Allergy to iodine

• Persistent large collection on follow up imaging 24-48 of post tube insertion that requires another drainage procedure

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Pleural Infection

Intervention

Drug:
• Povidone-Iodine pleural irrigation
Irrigation of the infected pleural cavity with an antiseptic solution to reduce microbial load

Locations

Country	Name	City	State
Egypt	Alexandria University Faculty of Medicine	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

References & Publications (8)

Agarwal R, Khan A, Aggarwal AN, Gupta D. Efficacy & safety of iodopovidone pleurodesis: a systematic review & meta-analysis. Indian J Med Res. 2012 Mar;135:297-304. Review. — View Citation

Cargill TN, Hassan M, Corcoran JP, Harriss E, Asciak R, Mercer RM, McCracken DJ, Bedawi EO, Rahman NM. A systematic review of comorbidities and outcomes of adult patients with pleural infection. Eur Respir J. 2019 Oct 1;54(3). pii: 1900541. doi: 10.1183/13993003.00541-2019. Print 2019 Sep. — View Citation

Corcoran JP, Psallidas I, Gerry S, Piccolo F, Koegelenberg CF, Saba T, Daneshvar C, Fairbairn I, Heinink R, West A, Stanton AE, Holme J, Kastelik JA, Steer H, Downer NJ, Haris M, Baker EH, Everett CF, Pepperell J, Bewick T, Yarmus L, Maldonado F, Khan B, Hart-Thomas A, Hands G, Warwick G, De Fonseka D, Hassan M, Munavvar M, Guhan A, Shahidi M, Pogson Z, Dowson L, Popowicz ND, Saba J, Ward NR, Hallifax RJ, Dobson M, Shaw R, Hedley EL, Sabia A, Robinson B, Collins GS, Davies HE, Yu LM, Miller RF, Maskell NA, Rahman NM. Prospective validation of the RAPID clinical risk prediction score in adult patients with pleural infection: the PILOT study. Eur Respir J. 2020 Nov 26;56(5). pii: 2000130. doi: 10.1183/13993003.00130-2020. Print 2020 Nov. Erratum in: Eur Respir J. 2020 Dec 17;56(6):. — View Citation

Davies HE, Davies RJ, Davies CW; BTS Pleural Disease Guideline Group. Management of pleural infection in adults: British Thoracic Society Pleural Disease Guideline 2010. Thorax. 2010 Aug;65 Suppl 2:ii41-53. doi: 10.1136/thx.2010.137000. Review. — View Citation

Kim SY, Flory J, Relton C. Ethics and practice of Trials within Cohorts: An emerging pragmatic trial design. Clin Trials. 2018 Feb;15(1):9-16. doi: 10.1177/1740774517746620. Epub 2017 Dec 11. — View Citation

Light RW. Parapneumonic effusions and empyema. Proc Am Thorac Soc. 2006;3(1):75-80. Review. — View Citation

Maskell NA, Davies CW, Nunn AJ, Hedley EL, Gleeson FV, Miller R, Gabe R, Rees GL, Peto TE, Woodhead MA, Lane DJ, Darbyshire JH, Davies RJ; First Multicenter Intrapleural Sepsis Trial (MIST1) Group. U.K. Controlled trial of intrapleural streptokinase for pleural infection. N Engl J Med. 2005 Mar 3;352(9):865-74. Erratum in: N Engl J Med. 2005 May 19;352(20):2146. — View Citation

Togo S, Ouattara MA, Sangaré I, Saye J, Touré CAS, Maiga IB, et al. Management for Pediatric Pleural Empyema in Resource-Poor Country: Is Chest Tube Drainage with Antiseptic Lavage-Irrigation Better than Tube Thoracostomy Alone? SS 2015;06(12):541-8.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events	Number of subjects with any adverse event (new chest pain, fever, dyspnoea or oxygen desaturation)	Within 24 hours after the second application of the study medication
Primary	Time to chest tube removal	Number of days from tube insertion to tube removal	Up to 8 weeks
Secondary	Time to defervescence	Numbers of days until resolution of fever	Up to 8 weeks
Secondary	Length of hospital stay	Number of days from admission/diagnosis until discharge from hospital	Up to 8 weeks
Secondary	Incidence of need for additional aspiration/tubes	Number of patients requiring additional drainage procedures during hospital admission	Up to 8 weeks
Secondary	Incidence of medical treatment of failure	Number of patients requiring surgical intervention	Up to 8 weeks