Clinical Trials Logo
  1. Home
  2. Pneumonia
  3. NCT04999592
  4. Details
NCT04999592 Clinical Trial

Ceftriaxone to PRevent pneumOnia and inflammatTion aftEr Cardiac arresT (PROTECT)

Pneumonia Clinical Trial

— PROTECT  

Official title:
Ceftriaxone to PRevent pneumOnia and inflammatTion aftEr Cardiac arresT (PROTECT): a Randomized-controlled Trial and Microbiome Assessment

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04999592
Other study ID # 1P20GM139745-01
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date August 20, 2021
Est. completion date June 30, 2024

Study information
Verified date October 2023
Source MaineHealth
Contact David Gagnon, PharmD
Phone 207-662-1338
Email dgagnon@mmc.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Randomized-controlled trial and microbiome assessment to understand the risk-to-benefit ratio of prophylactic antibiotics (Ceftriaxone) vs placebo in patients with pneumonia and inflammation after cardiac arrest outside the hospital.

Description:

Pneumonia is an infection of the lungs resulting in alveolar inflammation and fluid or purulent material accumulation. It is the most common infection after cardiac arrest occurring in up to 65% of patients treated with targeted temperature management. Pneumonia may result from aspiration during cardiopulmonary resuscitation (CPR), or by introduction of oropharyngeal flora into the lungs during airway management. Preventing infection after OHCA may: 1) reduce exposure to broad-spectrum antibiotics and subsequent collateral damage, 2) prevent hemodynamic derangements due to local and systemic inflammation, and 3) prevent an association between infection and morbidity and mortality. These benefits must be balanced with the risk for altering bacterial resistomes in the absence clinical infection. Accordingly, further study is warranted to understand the risk-to-benefit ratio of prophylactic antibiotics.

Recruitment information / eligibility
Status Recruiting
Enrollment 120
Est. completion date June 30, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - =18 years of age - Comatose (do not follow simple verbal commands) - Have any initial heart rhythm (shockable or non-shockable) - OHCA including the emergency department Exclusion Criteria: - Name on opt-out list - In-hospital cardiac arrest - Interval >6 hours from ICU admission to study drug receipt - Preexisting terminal disease making 180-day survival unlikely - Refused informed consent - Emergent coronary artery bypass grafting - Anaphylaxis or angioedema to beta-lactam antibiotics (i.e., cephalosporins or penicillins) - Under legal guardianship or prisoner - Known colonization with methicillin-resistant Staphylococcus aureus (MRSA) or vancomycin-resistant enterococcus (VRE) - Clinical bacterial infection prior to hospital admission defined as any one of the following: - Infectious prodrome preceding OHCA - Active course of antibiotics for infection prior to admission - Active infection documented in the electronic medical record - Family or surrogate endorsement of an active infection

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Standard of care without prophylaxis
Administer antibiotics in response to infection
• Antibiotic prophylaxis
Ceftriaxone 2 gm IV q12h for 3 days

Locations
Country Name City State
United States Maine Medical Center Portland Maine

Sponsors (4)
Lead Sponsor Collaborator
David J. Gagnon MaineHealth, National Institute of General Medical Sciences (NIGMS), University of New England

Country where clinical trial is conducted

United States, 

References & Publications (1)

Gagnon DJ, Ryzhov SV, May MA, Riker RR, Geller B, May TL, Bockian S, deKay JT, Eldridge A, Van der Kloot T, Lerwick P, Lord C, Lucas FL, Mailloux P, McCrum B, Searight M, Wirth J, Zuckerman J, Sawyer D, Seder DB. Ceftriaxone to PRevent pneumOnia and inflammaTion aftEr Cardiac arresT (PROTECT): study protocol for a randomized, placebo-controlled trial. Trials. 2022 Mar 4;23(1):197. doi: 10.1186/s13063-022-06127-w. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of Participants with Clinically-diagnosed Early-onset Pneumonia Percentage of Participants with Clinically-diagnosed Early-onset Pneumonia occurring <4 days after initiation of mechanical ventilation 4 days
Secondary Percentage of Participants with Microbiologically-confirmed Early-onset Pneumonia Percentage of Participants with Microbiologically-confirmed Early-onset Pneumonia occurring <4 days after initiation of mechanical ventilation 4 days
Secondary Percentage of Participants with Microbiologically-confirmed late-onset pneumonia Percentage of Participants with Microbiologically-confirmed late-onset pneumonia occurring =4 days after initiation of mechanical ventilation = 4 days
Secondary Percentage of Participants with Clinically-diagnosed late-onset pneumonia Percentage of Participants with Clinically-diagnosed late-onset pneumonia occurring =4 days after initiation of mechanical ventilation = 4 days
Secondary Percentage of Participants with non-pulmonary infections Percentage of Participants with non-pulmonary infections During the intervention and immediately after the intervention until hospital discharge, up to 6 months
Secondary ICU-free days during admission ICU-free days in the first 28 days of admission 28 days
Secondary Mechanical ventilator-free days during admission Mechanical ventilator-free days in the first 28 days of admission 28 days
Secondary ICU Length of Stay Intensive care unit length of stay During the intervention and immediately after the intervention until death or ICU discharge measured in days, up to 6 months
Secondary Hospital Length of Stay hospital length of stay During the intervention and immediately after the intervention until death or hospital discharge measured in days, up to 6 months
Secondary Percentage of Participants who die in the intensive care unit Percentage of Participants who die in the intensive care unit During the intervention and immediately after the intervention until death or ICU discharge
Secondary Percentage of Participants who Die in the Hospital Percentage of Participants who Die in the Hospital during admission During the intervention and immediately after the intervention until death or hospital discharge
Secondary Percentage of Participants Discharged Home or to Rehabilitation Percentage of Participants Discharged Home or to Rehabilitation During the intervention and immediately after the intervention until death or hospital discharge
Secondary Percentage of Participants Transferred to Another Hospital Percentage of Participants Transferred to Another Hospital During the intervention and immediately after the intervention until death or hospital transfer
Secondary Percentage of Participants with a Good Functional Outcome at Hospital Discharge Percentage of Participants with a Good Functional Outcome at Hospital Discharge Good functional outcome will be mRS =0-3 of or a CPC 1-2 After the intervention at the time the participant is discharged from the hospital
Secondary 13. Percentage of Participants with a Good Functional Outcome at 6 Months Post-hospital Discharge 13. Percentage of Participants with a Good Functional Outcome at 6 Months Post-hospital Discharge. Good functional outcome will be mRS =0-3 of or a CPC 1-2 6 months post-hospital discharge
Secondary Percentage of Participants with Clostridioides difficile-associated Diarrhea Percentage of Participants with Clostridioides difficile-associated Diarrhea During the intervention and immediately after the intervention until death or hospital discharge
Secondary Percentage of Participants with Type One Hypersensitivity Reactions Percentage of Participants with Type One (immediate-type) hypersensitivity reactions Three days
Secondary Percentage of Participants with Gallbladder disease Percentage of Participants with Gallbladder disease During the intervention and immediately after the intervention until death or hospital discharge
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04244474 - Effect of Vitamin D Supplementation on Improvement of Pneumonic Children Phase 1/Phase 2
Completed NCT05815264 - Clinical Trial of 23-valent Pneumococcal Polysaccharide Vaccine in Healthy Chinese Population Aged 2 Years and Above Phase 1
Recruiting NCT04589936 - Prone Position to Improve Oxygenation in COVID-19 Patients Outside Critical Care N/A
Completed NCT02905383 - The Effect of Exercise on Physical Function and Health in Older People After Discharge From Hospital N/A
Completed NCT06210737 - A Study to Evaluate Persistence of Immunity of PCV13 in Healthy Population Aged 2 Months，7 Months-5 Years Phase 4
Terminated NCT03944551 - Bubble Continuous Positive Airway Pressure for Children With Severe Pneumonia in Mali, Africa N/A
Terminated NCT04660084 - Impact of Molecular Testing on Improved Diagnosis, Treatment and Management of CAP N/A
Not yet recruiting NCT05649891 - Checklists Resuscitation Emergency Department N/A
Withdrawn NCT05702788 - Efficacy and Safety of Jaktinib in Participants With Severe Novel Coronavirus Pneumonia(COVID-19) Phase 2
Not yet recruiting NCT04171674 - Pharmacokinetics of High-dose Ceftobiprole in Community-acquired Pneumonia Under Mechanical Ventilation. N/A
Active, not recruiting NCT03140163 - Screening for Pneumonia: A Comparison of Ultra Low Dose Chest CT [ULD-CT] and Conventional Chest Radiography [CXR] N/A
Completed NCT02864420 - Hospitalization at Home: The Acute Care Home Hospital Program for Adults N/A
Completed NCT02638649 - Prehospital Use of Ultrasound in Undifferentiated Shortness of Breath
Recruiting NCT02515565 - Physiotherapy in Patients Hospitalized Due to Pneumonia. N/A
Completed NCT02105298 - Effect of Volume and Type of Fluid on Postoperative Incidence of Respiratory Complications and Outcome (CRC-Study) N/A
Completed NCT01446926 - Study of Investigational Pneumococcal Vaccine in Healthy Adults, Toddlers and Infants Phase 1
Completed NCT01399723 - Amoxicillin Versus Benzyl Penicillin for Treatment of Children Hospitalised With Severe Pneumonia Phase 3
Completed NCT01416519 - Physiotherapy Technique Decreases Respiratory Complications After Cardiac Operation N/A
Terminated NCT02358642 - Drug to Prevent Pneumonia in the Tube Fed Phase 4
Completed NCT01476995 - Prognostic Indicators as Provided by the EPIC ClearView N/A