Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2025-12-25 @ 5:39 PM
Study NCT ID:
NCT01414959
Status:
COMPLETED
Last Update Posted:
2017-08-29
First Post:
2011-08-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Target Site Pharmacokinetics of Doripenem at Steady State in Intubated Intensive Care Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D059413', 'term': 'Intraabdominal Infections'}, {'id': 'D014552', 'term': 'Urinary Tract Infections'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'plasma broncheoalvoeolar lavage microdialysates'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-28', 'studyFirstSubmitDate': '2011-08-10', 'studyFirstSubmitQcDate': '2011-08-10', 'lastUpdatePostDateStruct': {'date': '2017-08-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-08-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['intensive care patient', 'intubation', '(please change wording as you like!)'], 'conditions': ['Pneumonia', 'Abdominal Infection', 'Urinary Tract Infection']}, 'descriptionModule': {'briefSummary': 'The investigators will measure the pharmacokinetics of doripenem in skeletal muscle, subcutaneous adipose tissue, bronchoalveolar lavage and plasma of intubated intensive care patients.', 'detailedDescription': 'Methods: microdialysis, blood sampling, bronchoalveolar lavage'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'intubated patients, intensive care', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* endotracheal intubation; pneumonia or complicated abdominal infection or complicated urinary tract infection\n\nExclusion Criteria:\n\n* allergy to doripenem, hemodialysis'}, 'identificationModule': {'nctId': 'NCT01414959', 'briefTitle': 'Target Site Pharmacokinetics of Doripenem at Steady State in Intubated Intensive Care Patients', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'Target Site Pharmacokinetics of Doripenem at Steady State in Intubated Intensive Care Patients', 'orgStudyIdInfo': {'id': 'Dori_MD_ICU'}}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Med. Univ. of Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'overallOfficials': [{'name': 'Markus Zeitlinger, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical Universit of Vienna'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Dr.', 'investigatorFullName': 'Markus Zeitlinger', 'investigatorAffiliation': 'Medical University of Vienna'}}}}