Ignite Creation Date:
2025-12-25 @ 5:09 AM
Ignite Modification Date:
2025-12-26 @ 4:13 AM
Study NCT ID:
NCT00950027
Status:
TERMINATED
Last Update Posted:
2012-07-06
First Post:
2009-07-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Povidone Iodine to Reduce Pulmonary Infection in Head Trauma and Cerebral Hemorrhage in Intensive Care Unit
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053717', 'term': 'Pneumonia, Ventilator-Associated'}], 'ancestors': [{'id': 'D000077299', 'term': 'Healthcare-Associated Pneumonia'}, {'id': 'D003428', 'term': 'Cross Infection'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D007049', 'term': 'Iatrogenic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 179}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-04', 'studyFirstSubmitDate': '2009-07-30', 'studyFirstSubmitQcDate': '2009-07-30', 'lastUpdatePostDateStruct': {'date': '2012-07-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of ventilator associated pneumonia', 'timeFrame': '30 days'}], 'secondaryOutcomes': [{'measure': 'Time to ventilator associated pneumoniae', 'timeFrame': '30 days'}, {'measure': 'Rate of early (<=7 days) and late (>7 days) ventilator associated pneumoniae', 'timeFrame': '30 days'}, {'measure': 'Length of mechanical ventilation', 'timeFrame': '30 days'}, {'measure': 'Other infections', 'timeFrame': '30 days'}, {'measure': 'Acute respiratory distress syndrome', 'timeFrame': '30 days'}, {'measure': 'Treatments administered (antibiotics, sedatives, transfusion)', 'timeFrame': '30 days'}, {'measure': 'Length of ICU and hospital stay', 'timeFrame': 'Hospital discharge'}, {'measure': 'Death', 'timeFrame': 'ICU, 1 months, 3 months'}, {'measure': 'Oropharyngeal bacterial colonisation', 'timeFrame': '30 days'}, {'measure': 'Type of anesthetic agents received', 'timeFrame': '30 days'}, {'measure': 'Rate of tracheostomy', 'timeFrame': '30 days'}, {'measure': 'Rate of transfusion (red blood cells, platelets, plasma)', 'timeFrame': '30 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Ventilator Associated Pneumonia']}, 'referencesModule': {'references': [{'pmid': '24105456', 'type': 'DERIVED', 'citation': 'Seguin P, Laviolle B, Dahyot-Fizelier C, Dumont R, Veber B, Gergaud S, Asehnoune K, Mimoz O, Donnio PY, Bellissant E, Malledant Y; Study of Povidone Iodine to Reduce Pulmonary Infection in Head Trauma and Cerebral Hemorrhage Patients (SPIRIT) ICU Study Group; AtlanRea Group. Effect of oropharyngeal povidone-iodine preventive oral care on ventilator-associated pneumonia in severely brain-injured or cerebral hemorrhage patients: a multicenter, randomized controlled trial. Crit Care Med. 2014 Jan;42(1):1-8. doi: 10.1097/CCM.0b013e3182a2770f.'}]}, 'descriptionModule': {'briefSummary': 'Head trauma and severe cerebral hemorrhage are major risk factors for development of ventilator-associated pneumonia. In a previous open labelled, single center study the investigators showed that repeated oropharyngeal decontamination with povidone-iodine may be an effective strategy to decrease the prevalence of ventilator-associated pneumonia in patients with head trauma. The present study aims to confirm these results in a multicenter, double blind study including patients suffering from head trauma or cerebral hemorrhage.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adults \\> 18 years\n* Closed head trauma with a Glasgow Coma Score \\<=8 or cerebral Hemorrhage with a Glasgow Coma Score of \\<=8\n* Expected need mechanical ventilation for \\>=2 days\n* Written informed consent from the patient's next-of-kin. If no relative is present at the time of inclusion, the patients will be included according to the emergency procedure\n\nExclusion Criteria:\n\n* Impossibility to perform oropharyngeal decontamination within 12 h following the initial episode\n* Facial injury with impossibility to perform the oropharyngeal decontamination\n* Tetraplegia\n* Known history of reaction to iodine\n* Respiratory disease or pulmonary infiltrate(s) at inclusion\n* Need for curative antibiotics\n* Mercurial antiseptics treatment\n* Pregnancy"}, 'identificationModule': {'nctId': 'NCT00950027', 'acronym': 'SPIRIT-ICU', 'briefTitle': 'Study of Povidone Iodine to Reduce Pulmonary Infection in Head Trauma and Cerebral Hemorrhage in Intensive Care Unit', 'organization': {'class': 'OTHER', 'fullName': 'Rennes University Hospital'}, 'officialTitle': 'Prospective Randomized Double Blind Study Comparing the Effect of Oropharyngeal Decontamination by Povidone-iodine to Placebo on Ventilator-associated Pneumonia in Patients With Head Trauma or Cerebral Hemorrhage', 'orgStudyIdInfo': {'id': 'EudraCT 2006-006353-27'}, 'secondaryIdInfos': [{'id': 'AFSSAPS A70642-35', 'type': 'OTHER', 'domain': 'AFSSAPS: French Health Products Safety Agency'}, {'id': 'Sponsor PHRC/06-05 SPIRIT ICU', 'type': 'OTHER', 'domain': 'Rennes University Hospital'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'povidone iodine', 'description': 'Povidone iodine', 'interventionNames': ['Drug: povidone iodine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'povidone iodine', 'type': 'DRUG', 'description': 'oropharyngeal decontamination every 4 hours', 'armGroupLabels': ['povidone iodine']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'oropharyngeal decontamination every 4 hours', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Angers', 'country': 'France', 'facility': 'CHU Angers', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'city': 'Nantes', 'country': 'France', 'facility': 'Réanimation chirurgical Hopital Hotel Dieu-CHU de Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'city': 'Poitiers', 'country': 'France', 'facility': 'CHU de Poitiers', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'city': 'Rennes', 'country': 'France', 'facility': 'Surgical Intensive Care Unit - CHU de Rennes', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'city': 'Rouen', 'country': 'France', 'facility': 'CHU de Rouen', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'city': 'Tours', 'country': 'France', 'facility': 'Réanimation chirurgicale CHU Tours', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}, {'city': 'Vannes', 'country': 'France', 'facility': 'CHG Vannes', 'geoPoint': {'lat': 47.65688, 'lon': -2.76205}}], 'overallOfficials': [{'name': 'Philippe Seguin, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rennes University Hospital'}, {'name': 'Bruno Laviolle, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Rennes University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rennes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}