Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2026-02-19 @ 3:24 PM
Study NCT ID:
NCT03919851
Status:
COMPLETED
Last Update Posted:
2019-04-18
First Post:
2019-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Physician Administered Antibiotics in a Prehospital Setting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000900', 'term': 'Anti-Bacterial Agents'}, {'id': 'D000071997', 'term': 'Blood Culture'}], 'ancestors': [{'id': 'D000890', 'term': 'Anti-Infective Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D008828', 'term': 'Microbiological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 117}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-16', 'studyFirstSubmitDate': '2019-04-16', 'studyFirstSubmitQcDate': '2019-04-16', 'lastUpdatePostDateStruct': {'date': '2019-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prehospital diagnosis confirmed', 'timeFrame': 'Up to 30 days', 'description': 'Prehospital tentative diagnosis matches inhospital diagnosis'}], 'secondaryOutcomes': [{'measure': 'Blood culture positive', 'timeFrame': 'First day of admission', 'description': 'Findings in the blood culture supports the diagnosis sepsis'}, {'measure': 'Blood culture contamination below 5%', 'timeFrame': '6 days', 'description': 'Findings of bacteria attributed to contamination below 1 in 20 cultures'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prehospital recognition and treatment'], 'conditions': ['Sepsis']}, 'referencesModule': {'references': [{'pmid': '29690984', 'type': 'RESULT', 'citation': 'Perner A, Lassen AT, Schierbeck J, Storgaard M, Reiter N, Benfield T. [Disease burden and definition of sepsis in adults]. Ugeskr Laeger. 2018 Apr 9;180(15):V09170685. Danish.'}, {'pmid': '28234754', 'type': 'RESULT', 'citation': 'Seymour CW, Kahn JM, Martin-Gill C, Callaway CW, Yealy DM, Scales D, Angus DC. Delays From First Medical Contact to Antibiotic Administration for Sepsis. Crit Care Med. 2017 May;45(5):759-765. doi: 10.1097/CCM.0000000000002264.'}, {'pmid': '29564147', 'type': 'RESULT', 'citation': 'Moore C, Bulger J, Morgan M, Driscoll T, Porter A, Islam S, Smyth M, Perkins G, Sewell B, Rainer T, Nanayakkara P, Okolie C, Allen S, Fegan G, Davies J, Foster T, Francis N, Smith FG, Ellis G, Shanahan T, Howe R, Snooks H. Prehospital recognition and antibiotics for 999 patients with sepsis: protocol for a feasibility study. Pilot Feasibility Stud. 2018 Mar 12;4:64. doi: 10.1186/s40814-018-0258-8. eCollection 2018.'}, {'pmid': '27429693', 'type': 'RESULT', 'citation': 'Smyth MA, Brace-McDonnell SJ, Perkins GD. Impact of Prehospital Care on Outcomes in Sepsis: A Systematic Review. West J Emerg Med. 2016 Jul;17(4):427-37. doi: 10.5811/westjem.2016.5.30172. Epub 2016 Jul 5.'}, {'pmid': '23321295', 'type': 'RESULT', 'citation': 'Guerra WF, Mayfield TR, Meyers MS, Clouatre AE, Riccio JC. Early detection and treatment of patients with severe sepsis by prehospital personnel. J Emerg Med. 2013 Jun;44(6):1116-25. doi: 10.1016/j.jemermed.2012.11.003. Epub 2013 Jan 13.'}, {'pmid': '27393760', 'type': 'RESULT', 'citation': 'Joynes EL, Martin J, Ross M. Management of Septic Shock in the Remote Prehospital Setting. Air Med J. 2016 Jul-Aug;35(4):235-8. doi: 10.1016/j.amj.2016.04.001. Epub 2016 May 24.'}, {'pmid': '27507415', 'type': 'RESULT', 'citation': 'Bodilsen J, Dalager-Pedersen M, Schonheyder HC, Nielsen H. Time to antibiotic therapy and outcome in bacterial meningitis: a Danish population-based cohort study. BMC Infect Dis. 2016 Aug 9;16:392. doi: 10.1186/s12879-016-1711-z.'}, {'pmid': '29653787', 'type': 'RESULT', 'citation': 'Andersson H, Axelsson C, Larsson A, Bremer A, Gellerstedt M, Bang A, Herlitz J, Ljungstrom L. The early chain of care in bacteraemia patients: Early suspicion, treatment and survival in prehospital emergency care. Am J Emerg Med. 2018 Dec;36(12):2211-2218. doi: 10.1016/j.ajem.2018.04.004. Epub 2018 Apr 5.'}, {'pmid': '12795074', 'type': 'RESULT', 'citation': 'Justesen US, Larsen BW, Eshoj O, Sogaard P. [Blood cultures--indication and antibiotic therapy]. Ugeskr Laeger. 2003 May 5;165(19):1989-94. Danish.'}]}, 'descriptionModule': {'briefSummary': 'Sepsis is estimated to affect more than 30 million people globally. Detecting sepsis is notoriously difficult and there are no systems in place utilize prehospitally. In Denmark, the Mobile Emergency Care Unit (the MECU), manned by a physician and paramedic, is able to draw blood cultures and take venous lactate measurements before administering antibiotics.\n\nThis study aims to conduct a quality control on the ability of the MECU to recognize and treat sepsis by confirming the amounts of in-hospitally diagnosed cases. Furthermore the study investigates whether the blood cultures falls within an acceptable range of contamination.', 'detailedDescription': "In Denmark, the Emergency Medical System (EMS) consists of not only ambulances operated by paramedics and emergency technicians (EMTs) but also of Mobile Emergency Care Unit (MECU) staffed with an emergency physician with specialist training in anesthesiology and a paramedic. Only the physician on the MECU can administer prehospital antibiotics in Denmark; this emphasizes the importance of the first responding emergency units' capability in detecting and realizing the need for antibiotics in a patient so that the MECU can be requested and treatment initiated quickly.\n\nDetermining the administration of antibiotics is done at the anesthesiologists' discretion.\n\nThe purpose of administering antibiotics prehospitally is to reduce the time gap between suspicion of sepsis arises and the administration of antibiotics.\n\nThe purpose of this retrospective study is to conduct a quality control of the obtaining of blood cultures and of the administration of antibiotics in the prehospital setting serviced by the MECU in Odense in the Region of Southern Denmark in a time interval of 5 years (November 2013- October 2018).\n\nThe primary purpose is to associate the prehospital tentative diagnosis (assigned by the MECU) with the final diagnosis (ICD10 from hospital charts) including: 1: An indication for antibiotic therapy and 2: An assessment of the feasibility and potential benefit of the blood cultures obtained. 3: A description of the bacteria found in the blood cultures.\n\nThe association between initial prehospital diagnosis and final the diagnosis will be compared.\n\nSecondly the patients seen by the MECU will be characterized regarding diagnosis (ICD10-classification), age, sex, medication, and the first set of vital parameters (Heart rate, Blood pressure, Respratory rate, Oxygen saturation, Glasgow Coma Score, Temperature).\n\nHypothesis The indication for giving prehospital antibiotics is supported by the prehospital blood culture and by additional findings reproduced inhospitally.\n\nThe prehospital tentative diagnosis is confirmed in-hospitally. Prehospital blood sampling is associated with an acceptably low range of contamination."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients treated by the MECU in Odense from November 1st 2013 to October 31st 2018', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion: Criteria: Antibiotics administrated by prehospital physician\n\nExclusion: Criteria: Age below 18 years. No prehospital administration of antibiotics. Patients without inhospital medical records or patients released at the prehospital scene following treatment.'}, 'identificationModule': {'nctId': 'NCT03919851', 'acronym': 'PANTIPS', 'briefTitle': 'Physician Administered Antibiotics in a Prehospital Setting', 'organization': {'class': 'OTHER', 'fullName': 'Odense University Hospital'}, 'officialTitle': 'Physician Administered Antibiotics in a Prehospital Mobile Emergency Care Unit', 'orgStudyIdInfo': {'id': 'Prehospital antibiotics'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Antibiotics', 'type': 'DRUG', 'otherNames': ['Blood culture'], 'description': 'Administration of antibiotics'}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Odense', 'country': 'Denmark', 'facility': 'Mobile Emergency Care Unit in Odense', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Anonymized data may be shared on reasonable request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Odense University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Soren Mikkelsen', 'investigatorAffiliation': 'Odense University Hospital'}}}}