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Trial record 85 of 752 for:    Anti-Infective Agents AND Antibiotics, Antitubercular AND culture

Physician Administered Antibiotics in a Prehospital Setting (PANTIPS)

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ClinicalTrials.gov Identifier: NCT03919851
Recruitment Status : Completed
First Posted : April 18, 2019
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
Soren Mikkelsen, Odense University Hospital

Brief Summary:

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.

This 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.


Condition or disease Intervention/treatment
Sepsis Drug: Antibiotics

Detailed Description:

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.

Determining the administration of antibiotics is done at the anesthesiologists' discretion.

The purpose of administering antibiotics prehospitally is to reduce the time gap between suspicion of sepsis arises and the administration of antibiotics.

The 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).

The 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.

The association between initial prehospital diagnosis and final the diagnosis will be compared.

Secondly 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).

Hypothesis The indication for giving prehospital antibiotics is supported by the prehospital blood culture and by additional findings reproduced inhospitally.

The prehospital tentative diagnosis is confirmed in-hospitally. Prehospital blood sampling is associated with an acceptably low range of contamination.


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Study Type : Observational
Actual Enrollment : 117 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Physician Administered Antibiotics in a Prehospital Mobile Emergency Care Unit
Actual Study Start Date : October 31, 2018
Actual Primary Completion Date : February 15, 2019
Actual Study Completion Date : February 15, 2019

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: Antibiotics
    Administration of antibiotics
    Other Name: Blood culture


Primary Outcome Measures :
  1. Prehospital diagnosis confirmed [ Time Frame: Up to 30 days ]
    Prehospital tentative diagnosis matches inhospital diagnosis


Secondary Outcome Measures :
  1. Blood culture positive [ Time Frame: First day of admission ]
    Findings in the blood culture supports the diagnosis sepsis

  2. Blood culture contamination below 5% [ Time Frame: 6 days ]
    Findings of bacteria attributed to contamination below 1 in 20 cultures



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients treated by the MECU in Odense from November 1st 2013 to October 31st 2018
Criteria

Inclusion: Criteria: Antibiotics administrated by prehospital physician

Exclusion: Criteria: Age below 18 years. No prehospital administration of antibiotics. Patients without inhospital medical records or patients released at the prehospital scene following treatment.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03919851


Locations
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Denmark
Mobile Emergency Care Unit in Odense
Odense, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital

Publications of Results:

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Responsible Party: Soren Mikkelsen, Professor, Odense University Hospital
ClinicalTrials.gov Identifier: NCT03919851     History of Changes
Other Study ID Numbers: Prehospital antibiotics
First Posted: April 18, 2019    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Anonymized data may be shared on reasonable request

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Soren Mikkelsen, Odense University Hospital:
Prehospital recognition and treatment
Additional relevant MeSH terms:
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Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents