Antiseptic Irrigation for Pleural Infection
Antiseptic Pleural Irrigation for Patients With Pleural Infection
1 other identifier
interventional
36
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Mar 2021
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 13, 2021
CompletedFirst Posted
Study publicly available on registry
February 18, 2021
CompletedStudy Start
First participant enrolled
March 4, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 15, 2021
CompletedAugust 31, 2022
August 1, 2022
5 months
February 13, 2021
August 29, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
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
Time to chest tube removal
Number of days from tube insertion to tube removal
Up to 8 weeks
Secondary Outcomes (4)
Time to defervescence
Up to 8 weeks
Length of hospital stay
Up to 8 weeks
Incidence of need for additional aspiration/tubes
Up to 8 weeks
Incidence of medical treatment of failure
Up to 8 weeks
Study Arms (2)
Pleural irrigation with antiseptic
EXPERIMENTALTwo applications of 100-250 ml solution of 2% povidone-iodine will be irrigated into the pleural space of eligible patients 12 hours apart. The tube will be clamped for 15 minutes after irrigation and the patient will be asked to change position frequently during this period. The first dose will be applied 24-72 hours after tube insertion.
No pleural irrigation
NO INTERVENTIONStandard care
Interventions
Irrigation of the infected pleural cavity with an antiseptic solution to reduce microbial load
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Alexandria University Faculty of Medicine
Alexandria, Egypt
Related Publications (8)
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. No abstract available.
PMID: 20696693BACKGROUNDCorcoran 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):2000130. doi: 10.1183/13993003.00130-2020. Print 2020 Nov.
PMID: 32675200BACKGROUNDMaskell 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. doi: 10.1056/NEJMoa042473.
PMID: 15745977BACKGROUNDCargill 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):1900541. doi: 10.1183/13993003.00541-2019. Print 2019 Sep.
PMID: 31391221BACKGROUNDKim 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.
PMID: 29224380BACKGROUNDAgarwal R, Khan A, Aggarwal AN, Gupta D. Efficacy & safety of iodopovidone pleurodesis: a systematic review & meta-analysis. Indian J Med Res. 2012 Mar;135(3):297-304.
PMID: 22561614BACKGROUNDLight RW. Parapneumonic effusions and empyema. Proc Am Thorac Soc. 2006;3(1):75-80. doi: 10.1513/pats.200510-113JH.
PMID: 16493154BACKGROUNDTogo 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.
BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maged Hassan, PhD
Alexandria Faculty of Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Lecturer
Study Record Dates
First Submitted
February 13, 2021
First Posted
February 18, 2021
Study Start
March 4, 2021
Primary Completion
July 31, 2021
Study Completion
August 15, 2021
Last Updated
August 31, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- From published to study results up until five years after study completion
- Access Criteria
- Access will be granted upon reasonable request via email to the principal investigator
At completion of study assessments for the last recruited patients, data will be transferred from paper to electronic forms (spreadsheets) to allow statistical analysis. These spreadsheets will be stored securely after trial conclusion with the principal investigator and will be accessible to other members of the study team. Request to access study data by other teams will be expected via email and access will be granted by the principal investigator if the request is deemed reasonable.