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SepsisPANTIPSNCT03919851

Physician Administered Antibiotics in a Prehospital Setting

An observational study of Sepsis, run by Odense University Hospital at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sepsis
What is being tested?
Antibiotics
How many people
117 participants
Where
1 siteDenmark
Study dates
31 Oct 2018to 15 Feb 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: All patients treated by the MECU in Odense from November 1st 2013 to October 31st 2018

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.

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Mobile Emergency Care Unit in Odense

    Odense, 5000

Other trials in Denmark

About this study

Official title: Physician Administered Antibiotics in a Prehospital Mobile Emergency Care Unit

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.

Read the 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.

Conditions
Sepsis
Being tested
Antibiotics
Keywords
Prehospital recognition and treatment
Medical subject headings
Sepsis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AntibioticsDrug

    Also called Blood culture

    Administration of antibiotics

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prehospital diagnosis confirmed

    Prehospital tentative diagnosis matches inhospital diagnosis

    Measured: Up to 30 days

Secondary outcomes (2)

  1. Blood culture positive

    Findings in the blood culture supports the diagnosis sepsis

    Measured: First day of admission

  2. Blood culture contamination below 5%

    Findings of bacteria attributed to contamination below 1 in 20 cultures

    Measured: 6 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2019
  2. Study start31 Oct 2018
  3. Primary completion15 Feb 2019
  4. Study completion15 Feb 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
117 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03919851
Sponsor's protocol ID
Prehospital antibiotics
Acronym
PANTIPS
Status last verified
Apr 2019
First submitted
16 Apr 2019
Last updated
18 Apr 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Anonymized data may be shared on reasonable request

Publications

  • 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.

    PubMed 29690984

  • 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.

    PubMed 28234754

  • 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.

    PubMed 29564147

  • 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.

    PubMed 27429693

  • 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.

    PubMed 23321295

  • 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.

    PubMed 27393760

  • 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.

    PubMed 27507415

  • 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.

    PubMed 29653787

  • Justesen US, Larsen BW, Eshoj O, Sogaard P. [Blood cultures--indication and antibiotic therapy]. Ugeskr Laeger. 2003 May 5;165(19):1989-94. Danish.

    PubMed 12795074

Questions about this trial

What is this clinical trial studying?

An observational study of Sepsis, run by Odense University Hospital at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prehospital diagnosis confirmed (time frame: Up to 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03919851, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2019.

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