Trial Outcomes & Findings for Prophylactic Antibiotics in Admitted Cirrhotics (NCT NCT04218695)
NCT ID: NCT04218695
Last Updated: 2023-03-03
Results Overview
Incident bacterial infection after enrollment
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
32 participants
Primary outcome timeframe
For 7 days or until end of hospital stay
Results posted on
2023-03-03
Participant Flow
Enrolled inpatients only. Enrollment proceeded with intermittent interruption due to COVID pandemic.
Participant milestones
| Measure |
Treatment
1 gram intravenous ceftriaxone once daily for up to one week or until end of hospitalization
Ceftriaxone: Antibiotic
|
Placebo
Normal saline (50cc) once daily for up to one week or until end of hospitalization
Normal saline: 50cc intravenous once daily
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
15
|
|
Overall Study
COMPLETED
|
16
|
15
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Treatment
1 gram intravenous ceftriaxone once daily for up to one week or until end of hospitalization
Ceftriaxone: Antibiotic
|
Placebo
Normal saline (50cc) once daily for up to one week or until end of hospitalization
Normal saline: 50cc intravenous once daily
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
Baseline Characteristics
Prophylactic Antibiotics in Admitted Cirrhotics
Baseline characteristics by cohort
| Measure |
Treatment
n=17 Participants
1 gram intravenous ceftriaxone once daily for up to one week or until end of hospitalization
Ceftriaxone: Antibiotic
|
Placebo
n=15 Participants
Normal saline (50cc) once daily for up to one week or until end of hospitalization
Normal saline: 50cc intravenous once daily
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54 years
n=5 Participants
|
62 years
n=7 Participants
|
59 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=5 Participants
|
15 participants
n=7 Participants
|
32 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: For 7 days or until end of hospital stayIncident bacterial infection after enrollment
Outcome measures
| Measure |
Treatment
n=17 Participants
1 gram intravenous ceftriaxone once daily for up to one week or until end of hospitalization
Ceftriaxone: Antibiotic
|
Placebo
n=15 Participants
Normal saline (50cc) once daily for up to one week or until end of hospitalization
Normal saline: 50cc intravenous once daily
|
|---|---|---|
|
Infections
|
2 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Up to 30 daysDays in hospital after randomization
Outcome measures
| Measure |
Treatment
n=17 Participants
1 gram intravenous ceftriaxone once daily for up to one week or until end of hospitalization
Ceftriaxone: Antibiotic
|
Placebo
n=15 Participants
Normal saline (50cc) once daily for up to one week or until end of hospitalization
Normal saline: 50cc intravenous once daily
|
|---|---|---|
|
Length of Stay
|
9 days
Interval -5.0 to 23.0
|
10 days
Interval -2.0 to 22.0
|
SECONDARY outcome
Timeframe: Up to 30 daysIn-hospital
Outcome measures
| Measure |
Treatment
n=17 Participants
1 gram intravenous ceftriaxone once daily for up to one week or until end of hospitalization
Ceftriaxone: Antibiotic
|
Placebo
n=15 Participants
Normal saline (50cc) once daily for up to one week or until end of hospitalization
Normal saline: 50cc intravenous once daily
|
|---|---|---|
|
Mortality
|
1 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Up to 30-daysIncludes f/u after discharge
Outcome measures
| Measure |
Treatment
n=17 Participants
1 gram intravenous ceftriaxone once daily for up to one week or until end of hospitalization
Ceftriaxone: Antibiotic
|
Placebo
n=15 Participants
Normal saline (50cc) once daily for up to one week or until end of hospitalization
Normal saline: 50cc intravenous once daily
|
|---|---|---|
|
30-day Mortality
|
2 Participants
|
5 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 daysPositive stool toxin/PCR with new onset diarrhea
Outcome measures
| Measure |
Treatment
n=17 Participants
1 gram intravenous ceftriaxone once daily for up to one week or until end of hospitalization
Ceftriaxone: Antibiotic
|
Placebo
n=15 Participants
Normal saline (50cc) once daily for up to one week or until end of hospitalization
Normal saline: 50cc intravenous once daily
|
|---|---|---|
|
Incident C Difficile Colitis
|
0 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: During hospital admission up to 30 days(by NACSELD) or change in CLIF-C ACLF score
Outcome measures
| Measure |
Treatment
n=17 Participants
1 gram intravenous ceftriaxone once daily for up to one week or until end of hospitalization
Ceftriaxone: Antibiotic
|
Placebo
n=15 Participants
Normal saline (50cc) once daily for up to one week or until end of hospitalization
Normal saline: 50cc intravenous once daily
|
|---|---|---|
|
Incident ACLF
|
5 Participants
|
3 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: During hospital admission up to 30 daysIncident variceal hemorrhage
Outcome measures
| Measure |
Treatment
n=17 Participants
1 gram intravenous ceftriaxone once daily for up to one week or until end of hospitalization
Ceftriaxone: Antibiotic
|
Placebo
n=15 Participants
Normal saline (50cc) once daily for up to one week or until end of hospitalization
Normal saline: 50cc intravenous once daily
|
|---|---|---|
|
Incident Variceal Hemorrhage
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Upon discharge (or at 30 days)\>2 pts
Outcome measures
| Measure |
Treatment
n=17 Participants
1 gram intravenous ceftriaxone once daily for up to one week or until end of hospitalization
Ceftriaxone: Antibiotic
|
Placebo
n=15 Participants
Normal saline (50cc) once daily for up to one week or until end of hospitalization
Normal saline: 50cc intravenous once daily
|
|---|---|---|
|
Increase in MELD-Na
|
3 Participants
|
3 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: During hospital admission up to 30 daysIncident fungal infection (by culture data or requirement for new anti-fungal medication)
Outcome measures
| Measure |
Treatment
n=17 Participants
1 gram intravenous ceftriaxone once daily for up to one week or until end of hospitalization
Ceftriaxone: Antibiotic
|
Placebo
n=15 Participants
Normal saline (50cc) once daily for up to one week or until end of hospitalization
Normal saline: 50cc intravenous once daily
|
|---|---|---|
|
Fungal Infection
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Once at time of randomizationProcalcitonin
Outcome measures
| Measure |
Treatment
n=17 Participants
1 gram intravenous ceftriaxone once daily for up to one week or until end of hospitalization
Ceftriaxone: Antibiotic
|
Placebo
n=15 Participants
Normal saline (50cc) once daily for up to one week or until end of hospitalization
Normal saline: 50cc intravenous once daily
|
|---|---|---|
|
Biomarker of Infection
|
0.25 ng/mL
Interval 0.05 to 0.45
|
0.44 ng/mL
Interval 0.04 to 0.84
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Once at time of randomizationC-reactive protein
Outcome measures
| Measure |
Treatment
n=17 Participants
1 gram intravenous ceftriaxone once daily for up to one week or until end of hospitalization
Ceftriaxone: Antibiotic
|
Placebo
n=15 Participants
Normal saline (50cc) once daily for up to one week or until end of hospitalization
Normal saline: 50cc intravenous once daily
|
|---|---|---|
|
Biomarker of Infection
|
9.7 mg/L
Interval 2.5 to 16.9
|
11.0 mg/L
Interval 0.9 to 21.1
|
Adverse Events
Treatment
Serious events: 3 serious events
Other events: 4 other events
Deaths: 2 deaths
Placebo
Serious events: 5 serious events
Other events: 1 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Treatment
n=17 participants at risk
1 gram intravenous ceftriaxone once daily for up to one week or until end of hospitalization
Ceftriaxone: Antibiotic
|
Placebo
n=15 participants at risk
Normal saline (50cc) once daily for up to one week or until end of hospitalization
Normal saline: 50cc intravenous once daily
|
|---|---|---|
|
Hepatobiliary disorders
Hepatic Failure
|
5.9%
1/17 • 30 days
|
13.3%
2/15 • 30 days
|
|
Hepatobiliary disorders
Cerebral Edema
|
0.00%
0/17 • 30 days
|
6.7%
1/15 • 30 days
|
|
Infections and infestations
C. diff cile infection
|
0.00%
0/17 • 30 days
|
6.7%
1/15 • 30 days
|
|
Hepatobiliary disorders
Decompensated cirrhosis
|
11.8%
2/17 • 30 days
|
6.7%
1/15 • 30 days
|
|
Gastrointestinal disorders
Necrotizing pancreatitis
|
0.00%
0/17 • 30 days
|
6.7%
1/15 • 30 days
|
|
Vascular disorders
Pseudoaneurysm sma
|
0.00%
0/17 • 30 days
|
6.7%
1/15 • 30 days
|
|
Vascular disorders
Rectus sheath hematoma
|
5.9%
1/17 • 30 days
|
0.00%
0/15 • 30 days
|
|
Infections and infestations
Hospital acquired pneumonia
|
0.00%
0/17 • 30 days
|
6.7%
1/15 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Hypotension
|
0.00%
0/17 • 30 days
|
6.7%
1/15 • 30 days
|
Other adverse events
| Measure |
Treatment
n=17 participants at risk
1 gram intravenous ceftriaxone once daily for up to one week or until end of hospitalization
Ceftriaxone: Antibiotic
|
Placebo
n=15 participants at risk
Normal saline (50cc) once daily for up to one week or until end of hospitalization
Normal saline: 50cc intravenous once daily
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
5.9%
1/17 • 30 days
|
0.00%
0/15 • 30 days
|
|
Skin and subcutaneous tissue disorders
Pruritus with rash
|
5.9%
1/17 • 30 days
|
0.00%
0/15 • 30 days
|
|
Gastrointestinal disorders
Possible gastrointestinal bleed
|
5.9%
1/17 • 30 days
|
0.00%
0/15 • 30 days
|
|
Metabolism and nutrition disorders
hyperkalemia
|
5.9%
1/17 • 30 days
|
0.00%
0/15 • 30 days
|
|
Cardiac disorders
ventricular tachycardia
|
0.00%
0/17 • 30 days
|
6.7%
1/15 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
hypoxia
|
0.00%
0/17 • 30 days
|
6.7%
1/15 • 30 days
|
|
Infections and infestations
UTI
|
5.9%
1/17 • 30 days
|
0.00%
0/15 • 30 days
|
|
Hepatobiliary disorders
Hepatic Encephalopathy
|
5.9%
1/17 • 30 days
|
0.00%
0/15 • 30 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place