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| ID | Type | Description | Link |
|---|---|---|---|
| BIDMC-ABX-pilot-19 | Other Identifier | Beth Israel Deaconess Medical Center |
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| Name | Class |
|---|---|
| American Association for the Study of Liver Diseases | OTHER |
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In this pilot study, the investigators aim to assess feasibility of subject identification and data collection, including specimen processing, as well as the rate of enrollment for a future, larger study of the effect of empiric antibiotics for all patients with advanced cirrhosis admitted to the hospital without an existing indication for new antibiotic use. Specifically, the investigators will assess the incidence of infection after the time of enrollment and associated outcomes. Subjects will be randomly assigned to receive antibiotics vs placebo.
Cirrhosis is associated with a state of immune-compromise and progressive decompensation, acute on chronic liver failure (ACLF), and death are often caused by bacterial infections. Different sub-groups of patients with cirrhosis at increased risk, i.e. active upper gastrointestinal hemorrhage, low protein ascites, history of spontaneous bacterial peritonitis (SBP), are known to benefit from prophylactic antibiotics. The investigators hypothesize that hospitalized patients with advanced cirrhosis are also at increased risk and thus may benefit from preventive treatment. Subjects will be randomly assigned to receive an antibiotic vs placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | 1 gram intravenous ceftriaxone once daily for up to one week or until end of hospitalization |
|
| Placebo | Placebo Comparator | Normal saline (50cc) once daily for up to one week or until end of hospitalization |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ceftriaxone | Drug | Antibiotic |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Infections | Incident bacterial infection after enrollment | For 7 days or until end of hospital stay |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Stay | Days in hospital after randomization | Up to 30 days |
| Mortality | In-hospital | Up to 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incident C Difficile Colitis | Positive stool toxin/PCR with new onset diarrhea | 30 days |
| Incident ACLF | (by NACSELD) or change in CLIF-C ACLF score |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zachary P Fricker, MD | Beth Israel Deaconess Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38180983 | Derived | Fricker Z, Jiang G, Patel H, McLaughlin A, Izunza Barba S, Niezen S, Curry M. A randomized study of ceftriaxone for the prevention of infections in hospitalized patients with advanced cirrhosis. Hepatol Commun. 2024 Jan 5;8(1):e0356. doi: 10.1097/HC9.0000000000000356. eCollection 2024 Jan 1. |
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Enrolled inpatients only. Enrollment proceeded with intermittent interruption due to COVID pandemic.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | 1 gram intravenous ceftriaxone once daily for up to one week or until end of hospitalization Ceftriaxone: Antibiotic |
| FG001 | Placebo | Normal saline (50cc) once daily for up to one week or until end of hospitalization Normal saline: 50cc intravenous once daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | 1 gram intravenous ceftriaxone once daily for up to one week or until end of hospitalization Ceftriaxone: Antibiotic |
| BG001 | Placebo | Normal saline (50cc) once daily for up to one week or until end of hospitalization Normal saline: 50cc intravenous once daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Infections | Incident bacterial infection after enrollment | Posted | Count of Participants | Participants | For 7 days or until end of hospital stay |
|
|
30 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment | 1 gram intravenous ceftriaxone once daily for up to one week or until end of hospitalization Ceftriaxone: Antibiotic |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hepatic Failure | Hepatobiliary disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Zachary Fricker | BIDMC | 6176321070 | zfricker@bidmc.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 24, 2021 | Jul 26, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 26, 2021 | Jul 26, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D002443 | Ceftriaxone |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D002439 | Cefotaxime |
| D002505 | Cephacetrile |
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
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Double-blinded placebo-controlled trial
| Normal saline |
| Drug |
50cc intravenous once daily |
|
|
| 30-day Mortality | Includes f/u after discharge | Up to 30-days |
| During hospital admission up to 30 days |
| Incident Variceal Hemorrhage | Incident variceal hemorrhage | During hospital admission up to 30 days |
| Increase in MELD-Na | >2 pts | Upon discharge (or at 30 days) |
| Fungal Infection | Incident fungal infection (by culture data or requirement for new anti-fungal medication) | During hospital admission up to 30 days |
| Biomarker of Infection | Procalcitonin | Once at time of randomization |
| Biomarker of Infection | C-reactive protein | Once at time of randomization |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Counts |
|---|
| Participants |
|
|
| Secondary | Length of Stay | Days in hospital after randomization | Posted | Median | Inter-Quartile Range | days | Up to 30 days |
|
|
|
| Secondary | Mortality | In-hospital | Posted | Count of Participants | Participants | Up to 30 days |
|
|
|
| Secondary | 30-day Mortality | Includes f/u after discharge | Posted | Count of Participants | Participants | Up to 30-days |
|
|
|
| Other Pre-specified | Incident C Difficile Colitis | Positive stool toxin/PCR with new onset diarrhea | Posted | Count of Participants | Participants | 30 days |
|
|
|
| Other Pre-specified | Incident ACLF | (by NACSELD) or change in CLIF-C ACLF score | Posted | Count of Participants | Participants | During hospital admission up to 30 days |
|
|
|
| Other Pre-specified | Incident Variceal Hemorrhage | Incident variceal hemorrhage | Posted | Count of Participants | Participants | During hospital admission up to 30 days |
|
|
|
| Other Pre-specified | Increase in MELD-Na | >2 pts | Posted | Count of Participants | Participants | Upon discharge (or at 30 days) |
|
|
|
| Other Pre-specified | Fungal Infection | Incident fungal infection (by culture data or requirement for new anti-fungal medication) | Posted | Count of Participants | Participants | During hospital admission up to 30 days |
|
|
|
| Other Pre-specified | Biomarker of Infection | Procalcitonin | Posted | Median | Inter-Quartile Range | ng/mL | Once at time of randomization |
|
|
|
| Other Pre-specified | Biomarker of Infection | C-reactive protein | Posted | Median | Inter-Quartile Range | mg/L | Once at time of randomization |
|
|
|
| 2 |
| 17 |
| 3 |
| 17 |
| 4 |
| 17 |
| EG001 | Placebo | Normal saline (50cc) once daily for up to one week or until end of hospitalization Normal saline: 50cc intravenous once daily | 5 | 15 | 5 | 15 | 1 | 15 |
| Cerebral Edema | Hepatobiliary disorders | Non-systematic Assessment |
|
| C. diff cile infection | Infections and infestations | Non-systematic Assessment |
|
| Decompensated cirrhosis | Hepatobiliary disorders | Non-systematic Assessment |
|
| Necrotizing pancreatitis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Pseudoaneurysm sma | Vascular disorders | Non-systematic Assessment |
|
| Rectus sheath hematoma | Vascular disorders | Non-systematic Assessment |
|
| Hospital acquired pneumonia | Infections and infestations | Non-systematic Assessment |
|
| Hypotension | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Pruritus with rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Possible gastrointestinal bleed | Gastrointestinal disorders | Non-systematic Assessment |
|
| hyperkalemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| ventricular tachycardia | Cardiac disorders | Non-systematic Assessment |
|
| hypoxia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| UTI | Infections and infestations | Non-systematic Assessment |
|
| Hepatic Encephalopathy | Hepatobiliary disorders | Non-systematic Assessment |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D007769 |
| Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |