Trial Outcomes & Findings for Ceftriaxone to PRevent pneumOnia and inflammatTion aftEr Cardiac arresT (PROTECT) (NCT NCT04999592)

NCT ID: NCT04999592

Last Updated: 2025-04-17

Results Overview

Percentage of Participants with Clinically-diagnosed Early-onset Pneumonia occurring \<4 days after initiation of mechanical ventilation

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 53 participants
• Primary outcome timeframe: 4 days
• Results posted on: 2025-04-17

Participant Flow

Participant milestones

Measure	No Prophylaxis (Placebo) Standard care without antibiotic prophylaxis and treatment of infection if clinically warranted. Administer antibiotics in response to infection. Standard of care without prophylaxis: Administer antibiotics in response to infection	Prophylaxis Antibiotic prophylaxis for 3 days. Antibiotic prophylaxis with Ceftriaxone 2 gm IV q12h for 3 days. Antibiotic prophylaxis: Ceftriaxone 2 gm IV q12h for 3 days
Overall Study STARTED	27	26
Overall Study COMPLETED	26	26
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	No Prophylaxis (Placebo) Standard care without antibiotic prophylaxis and treatment of infection if clinically warranted. Administer antibiotics in response to infection. Standard of care without prophylaxis: Administer antibiotics in response to infection	Prophylaxis Antibiotic prophylaxis for 3 days. Antibiotic prophylaxis with Ceftriaxone 2 gm IV q12h for 3 days. Antibiotic prophylaxis: Ceftriaxone 2 gm IV q12h for 3 days
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	No Prophylaxis (Placebo) n=26 Participants Standard care without antibiotic prophylaxis and treatment of infection if clinically warranted. Administer antibiotics in response to infection. Standard of care without prophylaxis: Administer antibiotics in response to infection	Prophylaxis n=26 Participants Antibiotic prophylaxis for 3 days. Antibiotic prophylaxis with Ceftriaxone 2 gm IV q12h for 3 days. Antibiotic prophylaxis: Ceftriaxone 2 gm IV q12h for 3 days	Total n=52 Participants Total of all reporting groups
Age, Continuous	59 years n=5 Participants	60 years n=7 Participants	60 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	24 Participants n=7 Participants	46 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	26 Participants n=5 Participants	25 Participants n=7 Participants	51 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	25 Participants n=5 Participants	25 Participants n=7 Participants	50 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 4 days

Percentage of Participants with Clinically-diagnosed Early-onset Pneumonia occurring <4 days after initiation of mechanical ventilation

Outcome measures

Measure	No Prophylaxis (Placebo) n=26 Participants Standard care without antibiotic prophylaxis and treatment of infection if clinically warranted. Administer antibiotics in response to infection. Standard of care without prophylaxis: Administer antibiotics in response to infection	Prophylaxis n=26 Participants Antibiotic prophylaxis for 3 days. Antibiotic prophylaxis with Ceftriaxone 2 gm IV q12h for 3 days. Antibiotic prophylaxis: Ceftriaxone 2 gm IV q12h for 3 days
Clinically-diagnosed Early-onset Pneumonia	18 Participants	10 Participants

SECONDARY outcome

Timeframe: 4 days

Percentage of Participants with Microbiologically-confirmed Early-onset Pneumonia occurring <4 days after initiation of mechanical ventilation

Outcome measures

Measure	No Prophylaxis (Placebo) n=26 Participants Standard care without antibiotic prophylaxis and treatment of infection if clinically warranted. Administer antibiotics in response to infection. Standard of care without prophylaxis: Administer antibiotics in response to infection	Prophylaxis n=26 Participants Antibiotic prophylaxis for 3 days. Antibiotic prophylaxis with Ceftriaxone 2 gm IV q12h for 3 days. Antibiotic prophylaxis: Ceftriaxone 2 gm IV q12h for 3 days
Microbiologically-confirmed Early-onset Pneumonia	13 Participants	6 Participants

SECONDARY outcome

Timeframe: ≥ 4 days

Percentage of Participants with Microbiologically-confirmed late-onset pneumonia occurring ≥4 days after initiation of mechanical ventilation

Outcome measures

Measure	No Prophylaxis (Placebo) n=26 Participants Standard care without antibiotic prophylaxis and treatment of infection if clinically warranted. Administer antibiotics in response to infection. Standard of care without prophylaxis: Administer antibiotics in response to infection	Prophylaxis n=26 Participants Antibiotic prophylaxis for 3 days. Antibiotic prophylaxis with Ceftriaxone 2 gm IV q12h for 3 days. Antibiotic prophylaxis: Ceftriaxone 2 gm IV q12h for 3 days
Microbiologically-confirmed Late-onset Pneumonia	4 Participants	1 Participants

SECONDARY outcome

Timeframe: ≥ 4 days

Percentage of Participants with Clinically-diagnosed late-onset pneumonia occurring ≥4 days after initiation of mechanical ventilation

Outcome measures

Measure	No Prophylaxis (Placebo) n=26 Participants Standard care without antibiotic prophylaxis and treatment of infection if clinically warranted. Administer antibiotics in response to infection. Standard of care without prophylaxis: Administer antibiotics in response to infection	Prophylaxis n=26 Participants Antibiotic prophylaxis for 3 days. Antibiotic prophylaxis with Ceftriaxone 2 gm IV q12h for 3 days. Antibiotic prophylaxis: Ceftriaxone 2 gm IV q12h for 3 days
Clinically-diagnosed Late-onset Pneumonia	6 Participants	3 Participants

SECONDARY outcome

Timeframe: During the intervention and immediately after the intervention until hospital discharge, up to 6 months

Percentage of Participants with non-pulmonary infections

Outcome measures

Measure	No Prophylaxis (Placebo) n=26 Participants Standard care without antibiotic prophylaxis and treatment of infection if clinically warranted. Administer antibiotics in response to infection. Standard of care without prophylaxis: Administer antibiotics in response to infection	Prophylaxis n=26 Participants Antibiotic prophylaxis for 3 days. Antibiotic prophylaxis with Ceftriaxone 2 gm IV q12h for 3 days. Antibiotic prophylaxis: Ceftriaxone 2 gm IV q12h for 3 days
Non-pulmonary Infections	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 28 days

ICU-free days in the first 28 days of admission

Outcome measures

Measure	No Prophylaxis (Placebo) n=26 Participants Standard care without antibiotic prophylaxis and treatment of infection if clinically warranted. Administer antibiotics in response to infection. Standard of care without prophylaxis: Administer antibiotics in response to infection	Prophylaxis n=26 Participants Antibiotic prophylaxis for 3 days. Antibiotic prophylaxis with Ceftriaxone 2 gm IV q12h for 3 days. Antibiotic prophylaxis: Ceftriaxone 2 gm IV q12h for 3 days
ICU-free Days During Admission	0 days Interval 0.0 to 2.0	16 days Interval 0.0 to 24.0

SECONDARY outcome

Timeframe: 28 days

Mechanical ventilator-free days in the first 28 days of admission

Outcome measures

Measure	No Prophylaxis (Placebo) n=26 Participants Standard care without antibiotic prophylaxis and treatment of infection if clinically warranted. Administer antibiotics in response to infection. Standard of care without prophylaxis: Administer antibiotics in response to infection	Prophylaxis n=26 Participants Antibiotic prophylaxis for 3 days. Antibiotic prophylaxis with Ceftriaxone 2 gm IV q12h for 3 days. Antibiotic prophylaxis: Ceftriaxone 2 gm IV q12h for 3 days
Mechanical Ventilator-free Days During Admission	0 days Interval 0.0 to 8.0	25 days Interval 0.0 to 26.0

SECONDARY outcome

Timeframe: During the intervention (3 days) and immediately after the intervention until subject death or hospital discharge, an average of 30 days

Percentage of Participants who Die in the Hospital during admission

Outcome measures

Measure	No Prophylaxis (Placebo) n=26 Participants Standard care without antibiotic prophylaxis and treatment of infection if clinically warranted. Administer antibiotics in response to infection. Standard of care without prophylaxis: Administer antibiotics in response to infection	Prophylaxis n=26 Participants Antibiotic prophylaxis for 3 days. Antibiotic prophylaxis with Ceftriaxone 2 gm IV q12h for 3 days. Antibiotic prophylaxis: Ceftriaxone 2 gm IV q12h for 3 days
Death in the Hospital	19 Participants	11 Participants

SECONDARY outcome

Timeframe: 6 months post-hospital discharge

Median mRS (0 as no residual symptoms and 6 as death) at 6 Months Post-hospital Discharge

Outcome measures

Measure	No Prophylaxis (Placebo) n=26 Participants Standard care without antibiotic prophylaxis and treatment of infection if clinically warranted. Administer antibiotics in response to infection. Standard of care without prophylaxis: Administer antibiotics in response to infection	Prophylaxis n=26 Participants Antibiotic prophylaxis for 3 days. Antibiotic prophylaxis with Ceftriaxone 2 gm IV q12h for 3 days. Antibiotic prophylaxis: Ceftriaxone 2 gm IV q12h for 3 days
Functional Outcome at 6 Months Post-hospital Discharge	6 units on a scale Interval 6.0 to 6.0	6 units on a scale Interval 1.0 to 6.0

SECONDARY outcome

Timeframe: During the intervention and immediately after the intervention until death or hospital discharge

Percentage of Participants with Clostridioides difficile-associated Diarrhea

Outcome measures

Measure	No Prophylaxis (Placebo) n=26 Participants Standard care without antibiotic prophylaxis and treatment of infection if clinically warranted. Administer antibiotics in response to infection. Standard of care without prophylaxis: Administer antibiotics in response to infection	Prophylaxis n=26 Participants Antibiotic prophylaxis for 3 days. Antibiotic prophylaxis with Ceftriaxone 2 gm IV q12h for 3 days. Antibiotic prophylaxis: Ceftriaxone 2 gm IV q12h for 3 days
Clostridioides Difficile-associated Diarrhea	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Three days

Percentage of Participants with Type One (immediate-type) hypersensitivity reactions

Outcome measures

Measure	No Prophylaxis (Placebo) n=26 Participants Standard care without antibiotic prophylaxis and treatment of infection if clinically warranted. Administer antibiotics in response to infection. Standard of care without prophylaxis: Administer antibiotics in response to infection	Prophylaxis n=26 Participants Antibiotic prophylaxis for 3 days. Antibiotic prophylaxis with Ceftriaxone 2 gm IV q12h for 3 days. Antibiotic prophylaxis: Ceftriaxone 2 gm IV q12h for 3 days
Type One Hypersensitivity Reactions	0 Participants	0 Participants

SECONDARY outcome

Timeframe: During the intervention and immediately after the intervention until death or hospital discharge

Percentage of Participants with Gallbladder disease

Outcome measures

Measure	No Prophylaxis (Placebo) n=26 Participants Standard care without antibiotic prophylaxis and treatment of infection if clinically warranted. Administer antibiotics in response to infection. Standard of care without prophylaxis: Administer antibiotics in response to infection	Prophylaxis n=26 Participants Antibiotic prophylaxis for 3 days. Antibiotic prophylaxis with Ceftriaxone 2 gm IV q12h for 3 days. Antibiotic prophylaxis: Ceftriaxone 2 gm IV q12h for 3 days
Participants With Gallbladder Disease	0 Participants	0 Participants

Adverse Events

No Prophylaxis (Placebo)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 19 deaths

Prophylaxis

Serious events: 0 serious events

Other events: 0 other events

Deaths: 11 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

David J. Gagnon, PharmD - Principal Investigator

MaineHealth Maine Medical Center - Portland

Phone: 207-662-0111

Email: dgagnon@mmc.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place