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Anti-bacterial agent

Early Paramedic Treatment for Sepsis (PITSTOP Trial)

Phase 4

Recruiting

Led By Damon Scales, MD PhD FRCPC

Research Sponsored by Dr. Damon Scales

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 18 years

Patients with Sepsis, defined as (all 3 must be present): i) Paramedic suspects possible infection: e.g. suspected pneumonia, urinary tract infection, skin infection, bone and joint infection, intra-abdominal infection, meningitis ii) Presence of fever: Temperature ≥ 38.0°C measured by paramedic or history of fever during previous 24 hours iii) Presence of hypotension: Systolic blood pressure < 100mmHg

Must not have

Receiving oral or subcutaneous anticoagulants or low molecular weight heparin

Suspected acute congestive heart failure (CHF)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 90 days

Awards & highlights

Summary

This trial will help to determine whether paramedics can improve survival for patients with sepsis by providing early treatment.

Who is the study for?

Adults over 18 with suspected sepsis, indicated by possible infection, fever (≥38.0°C), and low blood pressure (systolic <100mmHg) can join. Excluded are those with stroke, heart failure, penicillin/cephalosporin allergy, severe trauma or bleeding, recent cardiac arrest or myocardial infarction, fluid overload signs, C. difficile infection in the past 6 weeks, pregnancy/breastfeeding or on certain anticoagulants.

What is being tested?

The PITSTOP trial is testing if early treatment for sepsis by paramedics improves survival rates. It compares two approaches: one group receives an antibiotic called Ceftriaxone and either liberal or conservative fluids before hospital arrival; the other gets a placebo instead of antibiotics.

What are the potential side effects?

Possible side effects from Ceftriaxone include allergic reactions like rash or itching, gastrointestinal issues such as nausea and diarrhea; Liberal fluid administration may lead to swelling due to excess fluid in the body.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have sepsis with suspected infection, fever over 38.0°C, and low blood pressure.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am taking blood thinners.

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I am suspected to have sudden heart failure.

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I have had a Clostridium difficile infection in the past 6 weeks.

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I am experiencing symptoms of fluid retention.

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I am suspected to have had a severe heart attack.

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My identity cannot be confirmed by name or health card.

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I am suspected to have had a stroke recently.

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I have recently experienced a severe injury.

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I am experiencing severe bleeding not caused by an injury.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during admission

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during admission

This trial's timeline: 3 weeks for screening, Varies for treatment, and during admission for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

: mortality prior to hospital discharge to day 90.

Secondary study objectives

Frequency distribution and mean time to first dose of antibiotics (if any) within first 24 hours of hospitalization

Microbiology results (if any)

Organ dysfunction during first 24 hours (mechanical ventilation, vasopressor therapy (any), dialysis

+12 more

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Comparison 2: Liberal fluidsExperimental Treatment1 Intervention

Paramedics will administer up to 2 litres of intravenous 0.9% saline solution to all participants in this arm regardless of blood pressure, reassessing for signs of volume overload after each 250ml.

Group II: Comparison 1: Prehospital CeftriaxoneActive Control1 Intervention

1g of Ceftriaxone will be administered by immediate intramuscular (IM) injection. The drug is provided in a sterile and completely covered vial as a white, odourless powder

Group III: Comparison 2: Conservative fluidsActive Control1 Intervention

Paramedics will administer 0.9% saline solution to participants who have systolic blood pressure \<90mmHg, and will only continue the infusion until the systolic blood pressure is \>=100mmHg.

Group IV: Comparison 1: PlaceboPlacebo Group1 Intervention

The placebo is provided in a sterile and completely covered vial.

0 / 11Eligibility criteria met

Find a Location

Who is running the clinical trial?

Canadian Institutes of Health Research (CIHR)OTHER_GOV

1,373 Previous Clinical Trials

26,517,202 Total Patients Enrolled

10 Trials studying Sepsis

7,240 Patients Enrolled for Sepsis

Sunnybrook Research InstituteOTHER

31 Previous Clinical Trials

213,745 Total Patients Enrolled

Dr. Damon ScalesLead Sponsor

Media Library

Ceftriaxone (Anti-bacterial agent) Clinical Trial Eligibility Overview. Trial Name: NCT03068741 — Phase 4

Sepsis Research Study Groups: Comparison 1: Prehospital Ceftriaxone, Comparison 2: Liberal fluids, Comparison 1: Placebo, Comparison 2: Conservative fluids

Sepsis Clinical Trial 2023: Ceftriaxone Highlights & Side Effects. Trial Name: NCT03068741 — Phase 4

Ceftriaxone (Anti-bacterial agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03068741 — Phase 4

~173 spots leftby Mar 2025

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