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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during admission
Awards & highlights
PITSTOP Trial 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.Check my eligibility
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.See study design
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.
PITSTOP Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I have sepsis with suspected infection, fever over 38.0°C, and low blood pressure.
PITSTOP Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 90 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
: mortality prior to hospital discharge to day 90.
Secondary outcome measures
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 morePITSTOP 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.
Find a Location
Who is running the clinical trial?
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,344 Previous Clinical Trials
26,451,377 Total Patients Enrolled
9 Trials studying Sepsis
4,740 Patients Enrolled for Sepsis
Sunnybrook Research InstituteOTHER
31 Previous Clinical Trials
213,779 Total Patients Enrolled
Dr. Damon ScalesLead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am taking blood thinners.I am 18 years old or older.I am suspected to have sudden heart failure.I have sepsis with suspected infection, fever over 38.0°C, and low blood pressure.I have had a Clostridium difficile infection in the past 6 weeks.I am experiencing symptoms of fluid retention.You have experienced a heart attack.You are allergic to penicillin or cephalosporin antibiotics.I am suspected to have had a severe heart attack.My identity cannot be confirmed by name or health card.I am suspected to have had a stroke recently.I have recently experienced a severe injury.I am experiencing severe bleeding not caused by an injury.
Research Study Groups:
This trial has the following groups:- Group 1: Comparison 1: Prehospital Ceftriaxone
- Group 2: Comparison 2: Liberal fluids
- Group 3: Comparison 1: Placebo
- Group 4: Comparison 2: Conservative fluids
Awards:
This trial has 4 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this experiment still have enrollment slots available?
"Affirmative. According to clinicaltrials.gov, this scientific project is actively seeking participants who meet the requirements of the trial - which was initially posted on March 23rd 2020 and last amended on October 18th 2022. 2040 patients need to be enrolled from 3 different health clinics."
Answered by AI
What medical condition does Comparison 2: Liberal fluids usually address?
"Liberal fluids are frequently utilized to manage sepsis caused by bacteria. It is also beneficial in treating bacterial infections, complicated urinary tract infections with a microbial cause, and preventing postoperative infection."
Answered by AI
Has the United States Food and Drug Administration endorsed Comparison 2: Liberal fluids?
"There is ample evidence to suggest that Comparison 2: Liberal Fluids has been approved, thus we rate its safety a 3."
Answered by AI
How many participants has this research endeavor welcomed so far?
"Affirmative. Clinicaltrials.gov's records state that this medical research, which was first posted on March 23rd 2020, is still recruiting participants. Approximately 2040 individuals are needed from 3 distinct facilities."
Answered by AI
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