Cirrhosis, LiverPhase 4NCT04218695
Prophylactic Antibiotics in Admitted Cirrhotics
A Phase 4 study testing Ceftriaxone and Normal saline in people with Cirrhosis, Liver, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis, Liver
- What is being tested?
- Ceftriaxone and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Aug 2020to 28 Aug 2021
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- MELD-Na >= 18
- Cirrhosis as defined by liver biopsy or a composite assessment of available results from imaging, elastography, prior records, and laboratory studies
Who cannot join
- Inability to obtain consent (from subject or next of kin/legal authorized representative (LAR)
- Allergy to cephalosporins
- Pregnancy (due to limited prospective data regarding safety of ceftriaxone)
- Existing indication for new antibiotics, e.g. upper gastrointestinal hemorrhage or apparent infection
- Use of major immunosuppressive medications (e.g. prednisone 20 mg/day or greater, immunosuppression for solid organ transplant)
- H/o recurrent C difficile infection within the past year (>2) or requiring fecal microbiota transplant (FMT)
- Enrollment in the study protocol during a previous admission
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: A Pilot Study of the Effect of Prophylactic Antibiotics on Hospitalized Patients With Advanced Cirrhosis
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.
Read the detailed description
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.
- Conditions
- Cirrhosis, Liver
- Being tested
- Ceftriaxone, Normal saline
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CeftriaxoneDrug
Also called Rocephin
Antibiotic
Normal salineDrug
Also called Placebo
50cc intravenous once daily
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | 1 gram intravenous ceftriaxone once daily for up to one week or until end of hospitalization Receives: Drug: Ceftriaxone |
| Placebo | Placebo comparator | Normal saline (50cc) once daily for up to one week or until end of hospitalization Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infections
Incident bacterial infection after enrollment
Measured: For 7 days or until end of hospital stay
Secondary outcomes (3)
Length of Stay
Days in hospital after randomization
Measured: Up to 30 days
Mortality
In-hospital
Measured: Up to 30 days
30-day Mortality
Includes f/u after discharge
Measured: Up to 30-days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2020
- Study start24 Aug 2020
- Primary completion31 May 2021
- Study completion28 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cirrhosis, LiverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- American Association for the Study of Liver Diseases
- Responsible party
- Principal investigator, Zachary Fricker, Beth Israel Deaconess Medical Center
- Investigators
- Zachary P Fricker, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04218695
- Sponsor's protocol ID
- 2020P000050
- Other IDs
- BIDMC-ABX-pilot-19
- Status last verified
- Feb 2023
- First submitted
- 2 Jan 2020
- Last updated
- 3 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38180983
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of the Effect of Prophylactic Antibiotics on Hospitalized Patients With Advanced Cirrhosis
- ClinicalTrials.gov ID
- NCT04218695
- Acronym / sponsor ID
- 2020P000050
- Conditions
- Cirrhosis, Liver
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- American Association for the Study of Liver Diseases
- Study start
- 24 Aug 2020 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 28 Aug 2021 (actual)
- First posted
- 6 Jan 2020 (actual)
- Results
- Posted 31 Aug 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Ceftriaxone1 gram intravenous ceftriaxone once daily for up to one week or until end of hospitalization |
| Placebo | Placebo comparator | Drug: Normal salineNormal saline (50cc) once daily for up to one week or until end of hospitalization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- MELD-Na >= 18
- Cirrhosis as defined by liver biopsy or a composite assessment of available results from imaging, elastography, prior records, and laboratory studies
Key exclusion criteria (7 listed)
- Inability to obtain consent (from subject or next of kin/legal authorized representative (LAR)
- Allergy to cephalosporins
- Pregnancy (due to limited prospective data regarding safety of ceftriaxone)
- Existing indication for new antibiotics, e.g. upper gastrointestinal hemorrhage or apparent infection
- Use of major immunosuppressive medications (e.g. prednisone 20 mg/day or greater, immunosuppression for solid organ transplant)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CeftriaxoneAlso: RocephinAntibiotic | Drug | Treatment |
| Normal salineAlso: Placebo50cc intravenous once daily | Drug | Placebo |
Primary outcome
Infections
Time frame: For 7 days or until end of hospital stay
Incident bacterial infection after enrollment
3 secondary outcomes
Length of Stay
Time frame: Up to 30 days
Mortality
Time frame: Up to 30 days
30-day Mortality
Time frame: Up to 30-days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38180983Fricker 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.
- Individual participant dataSharing planned: No
Related trials for Cirrhosis, Liver
Not yet recruitingObservational study
A Study of Fatigue, Itching and Daily Activities in People With Primary Biliary Cholangitis Starting Elafibranor
Primary Biliary Cholangitis (PBC)
RecruitingPhase 1/2
Nitazoxanide in Spontaneous Bacterial Peritonitis
SBP - Spontaneous Bacterial Peritonitis
RecruitingPhase 3
Fenofibrate for Patients With Primary Biliary Cirrhosis Who Had An Inadequate Response to Ursodeoxycholic Acid
Primary Biliary Cirrhosis
RecruitingPhase 1/2
N-Acetylcysteine in the Management of Spontaneous Bacterial Peritonitis
SBP - Spontaneous Bacterial Peritonitis
RecruitingPhase 2/3
Fenofibrate in Patients With Primary Biliary Cholangitis (PBC)
Primary Biliary Cholangitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zachary P Fricker, MD principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ceftriaxone and Normal saline in people with Cirrhosis, Liver, run by Beth Israel Deaconess Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infections (time frame: For 7 days or until end of hospital stay). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04218695, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2023.