Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 2:59 AM
Study NCT ID:
NCT01798602
Status:
TERMINATED
Last Update Posted:
2013-02-26
First Post:
2013-02-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Collaborative H1N1 Adjuvant Treatment (CHAT) Pilot Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}], 'ancestors': [{'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068718', 'term': 'Rosuvastatin Calcium'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005464', 'term': 'Fluorobenzenes'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'whyStopped': 'H1N1 pandemic concluded', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-22', 'studyFirstSubmitDate': '2013-02-19', 'studyFirstSubmitQcDate': '2013-02-22', 'lastUpdatePostDateStruct': {'date': '2013-02-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of eligible patients enrolled in the CHAT study', 'timeFrame': 'Over 6 month period or during H1N1 pandemic', 'description': 'This was a pilot study whose primary goal was to evaluate the feasibility of patient recruitment during an emerging pandemic'}], 'secondaryOutcomes': [{'measure': 'Adherence to the medication administration regimen as outlined in the study protocol.', 'timeFrame': '2 weeks'}, {'measure': 'Proportion of completed primary and secondary endpoints for the planned full CHAT trial that are collected.', 'timeFrame': '6 months'}, {'measure': 'The number of study withdrawals due to administration of open label statins and withdrawals of consent.', 'timeFrame': 'Up to 28 days or until hospital discharge'}, {'measure': 'Recruitment rates by consent model.', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['H1N1', 'Rosuvastatin'], 'conditions': ['H1N1 Influenza']}, 'referencesModule': {'references': [{'pmid': '21388549', 'type': 'BACKGROUND', 'citation': 'Burns KE, Chant C, Smith O, Cuthbertson B, Fowler R, Cook DJ, Kruger P, Webb S, Alhashemi J, Dominguez-Cherit G, Zala C, Rubenfeld GD, Marshall JC. A Canadian Critical Care Trials Group project in collaboration with the international forum for acute care trialists - Collaborative H1N1 Adjuvant Treatment pilot trial (CHAT): study protocol and design of a randomized controlled trial. Trials. 2011 Mar 9;12:70. doi: 10.1186/1745-6215-12-70.'}], 'seeAlsoLinks': [{'url': 'http://www.infactglobal.org', 'label': 'International Forum for Acute Care Trialists Website'}, {'url': 'http://www.ccctg.ca', 'label': 'Canadian Critical Care Trials Group'}]}, 'descriptionModule': {'briefSummary': 'The CHAT Pilot Trial is designed to compare rosuvastatin against placebo in patients with suspected H1N1. The pilot study will assess the feasibility of our clinical protocols, and study procedures.', 'detailedDescription': 'This trial is a pilot study to assess the feasibility and acceptability of a double blind randomized controlled trial (RCT) evaluating the efficacy of rosuvastatin as adjuvant therapy for H1N1 influenza'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Critically ill adult patients \\> 16 years of age admitted to an adult ICU for any reason with suspected, probable or confirmed novel swine origin influenza A/H1N1 infection\n* Requiring mechanical ventilation (invasive or non-invasive)\n* Receiving antiviral therapy (any medication at any dose and for any intended duration) for \\< 72 hours\n* Clinicians must have a 'moderate', 'high' or 'moderate to high' index of suspicion for H1N1\n\nExclusion Criteria:\n\n* Age \\< 16 years\n* Do not resuscitate or re-intubate order documented on chart or anticipated withdrawal of life support\n* Weight \\< 40 kg\n* Unable to receive or unlikely to absorb enteral study drug (e.g. incomplete or complete bowel obstruction, intestinal ischemia, infarction, short bowel syndrome)\n* Rosuvastatin specific exclusions:\n\n 1. Already receiving a statin (Atorvastatin, Lovastatin, Simvastatin, Pravastatin, Rosuvastatin)\n 2. Allergy or intolerance to statins\n 3. Receiving niacin, fenofibrate, cyclosporine, gemfibrozil, lopinavir, ritonavir or planned use of oral contraceptives or estrogen therapy during the ICU stay\n 4. CK exceeds 10 times ULN or ALT exceeds 8 times the ULN\n* Severe chronic liver disease (Child-Pugh Score 11-15) (see Appendix 6)\n* Previous enrolment in this trial\n* Pregnancy or breast feeding\n* At the time of enrolment, patients must not have received \\>72 hours of antiviral therapy"}, 'identificationModule': {'nctId': 'NCT01798602', 'acronym': 'CHAT Pilot', 'briefTitle': 'Collaborative H1N1 Adjuvant Treatment (CHAT) Pilot Trial', 'organization': {'class': 'OTHER', 'fullName': 'Canadian Critical Care Trials Group'}, 'officialTitle': 'Collaborative H1N1 Adjuvant Treatment (CHAT) Pilot Trial', 'orgStudyIdInfo': {'id': 'CCCTG'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rosuvastatin', 'description': 'Rosuvastatin 40 mg via nasogastric tube then 20 mg po or via nasogastric tube daily for 14 days or until hospital discharge Placebo is identical capsule with no active drug\n\nBoth are crushed for administration', 'interventionNames': ['Drug: Rosuvastatin or identical placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Identical drug vehicle with no active agent', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Rosuvastatin or identical placebo', 'type': 'DRUG', 'otherNames': ['Crestor', 'Placebo'], 'description': 'Tablet crushed for administration via feeding tube', 'armGroupLabels': ['Rosuvastatin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Identical placebo for rosuvastatin', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5B 1W8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': "St. Michael's Hospital", 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Canadian Critical Care Trials Group', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}, {'name': "The Physicians' Services Incorporated Foundation", 'class': 'OTHER'}, {'name': 'Public Health Agency of Canada (PHAC)', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}