Ignite Creation Date:
2025-12-25 @ 2:56 AM
Ignite Modification Date:
2026-01-09 @ 10:31 AM
Study NCT ID:
NCT04761133
Status:
COMPLETED
Last Update Posted:
2022-08-31
First Post:
2021-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Antiseptic Irrigation for Pleural Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011206', 'term': 'Povidone-Iodine'}], 'ancestors': [{'id': 'D007466', 'term': 'Iodophors'}, {'id': 'D017613', 'term': 'Iodine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D011145', 'term': 'Polyvinyls'}, {'id': 'D014753', 'term': 'Vinyl Compounds'}, {'id': 'D000475', 'term': 'Alkenes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011205', 'term': 'Povidone'}, {'id': 'D011760', 'term': 'Pyrrolidinones'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010969', 'term': 'Plastics'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-02-10', 'size': 184015, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-02-13T10:17', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2021-08-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-29', 'studyFirstSubmitDate': '2021-02-13', 'studyFirstSubmitQcDate': '2021-02-17', 'lastUpdatePostDateStruct': {'date': '2022-08-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of adverse events', 'timeFrame': 'Within 24 hours after the second application of the study medication', 'description': 'Number of subjects with any adverse event (new chest pain, fever, dyspnoea or oxygen desaturation)'}, {'measure': 'Time to chest tube removal', 'timeFrame': 'Up to 8 weeks', 'description': 'Number of days from tube insertion to tube removal'}], 'secondaryOutcomes': [{'measure': 'Time to defervescence', 'timeFrame': 'Up to 8 weeks', 'description': 'Numbers of days until resolution of fever'}, {'measure': 'Length of hospital stay', 'timeFrame': 'Up to 8 weeks', 'description': 'Number of days from admission/diagnosis until discharge from hospital'}, {'measure': 'Incidence of need for additional aspiration/tubes', 'timeFrame': 'Up to 8 weeks', 'description': 'Number of patients requiring additional drainage procedures during hospital admission'}, {'measure': 'Incidence of medical treatment of failure', 'timeFrame': 'Up to 8 weeks', 'description': 'Number of patients requiring surgical intervention'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pleural Infection']}, 'referencesModule': {'references': [{'pmid': '20696693', 'type': 'BACKGROUND', '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. No abstract available.'}, {'pmid': '32675200', 'type': 'BACKGROUND', '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):2000130. doi: 10.1183/13993003.00130-2020. Print 2020 Nov.'}, {'pmid': '15745977', 'type': 'BACKGROUND', '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. doi: 10.1056/NEJMoa042473.'}, {'pmid': '31391221', 'type': 'BACKGROUND', '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):1900541. doi: 10.1183/13993003.00541-2019. Print 2019 Sep.'}, {'pmid': '29224380', 'type': 'BACKGROUND', '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.'}, {'pmid': '22561614', 'type': 'BACKGROUND', 'citation': '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(3):297-304.'}, {'pmid': '16493154', 'type': 'BACKGROUND', 'citation': 'Light RW. Parapneumonic effusions and empyema. Proc Am Thorac Soc. 2006;3(1):75-80. doi: 10.1513/pats.200510-113JH.'}, {'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThis 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.', 'detailedDescription': '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.\n\nThis 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).\n\nThe 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.\n\nThe 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.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n* Pleural collection is unilocular on pre-drainage imaging. Presence of septations on ultrasound examination is allowed.\n\nExclusion Criteria:\n\n* Known or suspected thyroid disease\n* Allergy to iodine\n* Persistent large collection on follow up imaging 24-48 of post tube insertion that requires another drainage procedure'}, 'identificationModule': {'nctId': 'NCT04761133', 'briefTitle': 'Antiseptic Irrigation for Pleural Infection', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'Antiseptic Pleural Irrigation for Patients With Pleural Infection', 'orgStudyIdInfo': {'id': '04/24/11/10/2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pleural irrigation with antiseptic', 'description': 'Two 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.', 'interventionNames': ['Drug: Povidone-Iodine pleural irrigation']}, {'type': 'NO_INTERVENTION', 'label': 'No pleural irrigation', 'description': 'Standard care'}], 'interventions': [{'name': 'Povidone-Iodine pleural irrigation', 'type': 'DRUG', 'otherNames': ['Betadine'], 'description': 'Irrigation of the infected pleural cavity with an antiseptic solution to reduce microbial load', 'armGroupLabels': ['Pleural irrigation with antiseptic']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alexandria', 'country': 'Egypt', 'facility': 'Alexandria University Faculty of Medicine', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}], 'overallOfficials': [{'name': 'Maged Hassan, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Alexandria Faculty of Medicine'}]}, 'ipdSharingStatementModule': {'timeFrame': 'From published to study results up until five years after study completion', 'ipdSharing': 'YES', 'description': '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.', 'accessCriteria': 'Access will be granted upon reasonable request via email to the principal investigator'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alexandria University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Lecturer', 'investigatorFullName': 'Maged Hassan', 'investigatorAffiliation': 'Alexandria University'}}}}