Ignite Creation Date:
2025-12-24 @ 10:03 PM
Ignite Modification Date:
2025-12-25 @ 7:40 PM
Study NCT ID:
NCT01346735
Status:
COMPLETED
Last Update Posted:
2016-09-01
First Post:
2011-05-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multi-center Observational Study to Evaluate Epidemiology and Resistance Patterns of Common ICU-Infections (MOSER)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003428', 'term': 'Cross Infection'}, {'id': 'D053717', 'term': 'Pneumonia, Ventilator-Associated'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D007049', 'term': 'Iatrogenic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000077299', 'term': 'Healthcare-Associated Pneumonia'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 381}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-30', 'studyFirstSubmitDate': '2011-05-02', 'studyFirstSubmitQcDate': '2011-05-02', 'lastUpdatePostDateStruct': {'date': '2016-09-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-05-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Ventilator associated pneumonia', 'Catheter related blood stream infection', 'Catheter associated urinary tract infection', 'ICU-related infections (VAP, CAUTI and CRBSI)', 'India'], 'conditions': ['Nosocomial Infections']}, 'descriptionModule': {'briefSummary': 'Most literature on ICU infections and the resistant patterns comes from the western literature. This data may not truly reflect the incidence, epidemiology and resistance patterns in developing countries such as India. However, empiric antibiotic therapy is generally initiated using western guidelines. This can potentially lead to inadequate, inappropriate and ineffective empiric antibiotic therapy for ICU infections in the Indian setting. Hence in this multi-center observational study, we seek to:\n\n1. To determine the incidence of ICU-related infections (VAP, CAUTI and CRBSI) in India\n2. To explore the microbiology, resistance and treatment patterns of these infections'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult ICU patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. ICU stay \\>48 hours\n2. One of the following infections (VAP, CAUTI or CRBSI)\n\nExclusion Criteria:\n\n1. Index ICU stay \\< 48 hours\n2. Re-admissions to the ICU within the same hospitalization\n3. Age \\>18 years or \\<70 years\n4. Known HIV serology positivity\n5. Burns\n6. Solid organ or Bone-marrow transplant\n7. No ICU-acquired infections (specifically VAP, CAUTI and CRBSI)'}, 'identificationModule': {'nctId': 'NCT01346735', 'acronym': 'MOSER', 'briefTitle': 'Multi-center Observational Study to Evaluate Epidemiology and Resistance Patterns of Common ICU-Infections (MOSER)', 'organization': {'class': 'OTHER', 'fullName': 'Indian Society of Critical Care Medicine'}, 'officialTitle': 'Multi-center Observational Study to Evaluate Epidemiology and Resistance Patterns of Common ICU-Infections (MOSER)', 'orgStudyIdInfo': {'id': 'ISCCM1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ICU infections', 'description': 'Infections acquired during the ICU stay', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'armGroupLabels': ['ICU infections']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Mumbai', 'country': 'India', 'facility': 'Indian Society of Critical Care Medicine', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indian Society of Critical Care Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Dr. Ramesh Venkataraman', 'investigatorAffiliation': 'Indian Society of Critical Care Medicine'}}}}