CirrhosisNCT04153604
Doxycycline for the Prevention of Spontaneous Bacterial Peritonitis
An observational study of Cirrhosis and Spontaneous Bacterial Peritonitis, run by Methodist Health System at 1 site in United States.
Trial summary
The utilization of doxycycline for SBP prophylaxis is a novel practice at MDMC. Therefore, an assessment of safety and efficacy is needed in order to generalize this practice. The publication of this study can potentially introduce a new alternative to guideline-directed therapies for secondary prevention of SBP. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cirrhosis, Spontaneous Bacterial Peritonitis
- What is being tested?
- doxycycline
- How many people
- 841 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Nov 2019to 7 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients hospitalized at MDMC at the Liver Institute Clinic with a diagnosis of SBP based on ascitic fluid PMN count greater than 250 cells/mm3 from July 2014 to July 2018.
Who may be able to join
- Patients ≥ 18 year-old with refractory ascites who are candidates for SBP prophylaxis per clinician's decision
- Patients diagnosed with cirrhosis based on clinical criteria
- Patients with a diagnosis of SBP confirmed by paracentesis
Who cannot join
- Patients who have secondary peritonitis other than SBP
- Patients who have a history of liver transplant prior to the initial episode of SBP
- Patients with incomplete medical records
Trial locations and contacts
1 site in 1 country.
United States1 site
Methodist Dallas Medical Center
Dallas, Texas, 75203
About this study
The utilization of doxycycline for SBP prophylaxis is a novel practice at MDMC. Therefore, an assessment of safety and efficacy is needed in order to generalize this practice. The publication of this study can potentially introduce a new alternative to guideline-directed therapies for secondary prevention of SBP. Doxycycline is non-inferior to guideline-directed therapies regarding safety and efficacy in primary and secondary prophylaxis for SBP.
Read the detailed description
Spontaneous bacterial peritonitis (SBP) is a common and serious complication in cirrhotic patients with a reported mortality rate of 20 to 30%.1-3 A SBP diagnosis requires abdominal paracentesis and is made in the presence of an elevated ascitic fluid absolute polymorphonuclear leukocyte (PMN) count without an evident intra-abdominal, surgically treatable source of infection.2,3 Common pathogens associated with SBP are Gram-negative colonic organisms. However, in recent years, Gram-positive pathogens have become more common, suggesting the need to evaluate SBP management.1,4-6 The recurrence rate of SBP after an initial episode has been reported to be as high as 70%.1-3 Currently, the American Association for the Study of Liver Disease (AASLD) and European Association for the Study of the Liver (EASL) guidelines recommend the use of sulfamethoxazole/trimethoprim, norfloxacin, or ciprofloxacin for the prevention of recurrent SBP. Fluoroquinolones as a class have had increased black box warnings in recent years, making ciprofloxacin fall out of favor for long-term prophylaxis.5 Sulfamethoxazole/trimethoprim is extensively metabolized by the liver and is contraindicated in marked liver impairment.8 Therefore, it is necessary to search for a prophylaxis alternative with similar efficacy and a better safety profile.
Doxycycline is a broad-spectrum antibiotic that covers Gram-positive bacteria, including Streptococcus spp., resistant strains of Staphylococcus and Enterococcus, and Gram-negative bacteria, including Enterobacteriaceae. One randomized trial in cirrhotic patients with a previous episode of SBP showed that doxycycline was associated with a reduction in inflammatory markers, such as interleukin-6 and C-reactive protein, suggesting potential benefits of doxycycline in this patient population.7 At Methodist Dallas Medical Center (MDMC) and the Liver Institute at MDMC, doxycycline has been utilized for both primary and secondary prevention of SBP. In order to compare doxycycline with guideline-directed therapies for SBP prevention in cirrhotic patients, a retrospective, cohort study was designed to review patients who meet the criteria from July 2014 to July 2018. This study aims to compare the efficacy of doxycycline with that of guideline recommended therapies for primary and secondary SBP prophylaxis, the safety of doxycycline with that of guideline recommended therapies for primary and secondary SBP prophylaxis, and identify the association between chemoprophylaxis and the risk of infections from multidrug resistant organisms (MDROs) in SBP.
- Conditions
- Cirrhosis, Spontaneous Bacterial Peritonitis
- Being tested
- doxycycline
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
doxycyclineDrug
a tetracycline antibiotic that fights bacteria in the body.
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of reported SBP
Occurrence of reported SBP within 1-year of chemoprophylaxis initiation
Measured: July 2014 to July 2018
Secondary outcomes (8)
Incidences of death
Incidences of death within 1-year of chemoprophylaxis initiation
Measured: July 2014 to July 2018
Incidences of Liver transplant
Incidences of liver transplant within 1-year of chemoprophylaxis initiation
Measured: July 2014 to July 2018
Incidences of bacteremia
Incidences of bacteremia within 1-year of chemoprophylaxis initiation
Measured: July 2014 to July 2018
Hospitalizations and ED visits due to AKI
Hospitalizations and ED visits due to AKI within 1-year of chemoprophylaxis initiation
Measured: July 2014 to July 2018
Hospitalizations and ED visits due to Clostridioides difficile infection
Hospitalizations and ED visits due to Clostridioides difficile infection within 1-year of chemoprophylaxis initiation
Measured: July 2014 to July 2018
Hospitalizations and ED visits due to diarrhea
Hospitalizations and ED visits due to diarrhea within 1-year of chemoprophylaxis initiation
Measured: July 2014 to July 2018
Hospitalizations and ED visits due to hyperkalemia
Hospitalizations and ED visits due to hyperkalemia within 1-year of chemoprophylaxis initiation
Measured: July 2014 to July 2018
Rate of infection with MDRO
Rate of infection with MDRO within 1-year of chemoprophylaxis initiation
Measured: July 2014 to July 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2019
- Study start4 Nov 2019
- Primary completion7 Aug 2020
- Study completion7 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 841 participants (actual)
Sponsor and investigators
- Lead sponsor
- Methodist Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jessica Rago, PharmD, Principal investigator, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04153604
- Sponsor's protocol ID
- 061.PHA.2019.D
- Status last verified
- Mar 2024
- First submitted
- 4 Nov 2019
- Last updated
- 20 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Doxycycline for the Prevention of Spontaneous Bacterial Peritonitis
- ClinicalTrials.gov ID
- NCT04153604
- Acronym / sponsor ID
- 061.PHA.2019.D
- Conditions
- Cirrhosis, Spontaneous Bacterial Peritonitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 841 participants (actual)
- Lead sponsor
- Methodist Health SystemUniversity, hospital or other
- Study start
- 4 Nov 2019 (actual)
- Primary completion
- 7 Aug 2020 (actual)
- Study completion
- 7 Aug 2020 (actual)
- First posted
- 6 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The utilization of doxycycline for SBP prophylaxis is a novel practice at MDMC. Therefore, an assessment of safety and efficacy is needed in order to generalize this practice. The publication of this study can potentially introduce a new alternative to guideline-directed therapies for secondary prevention of SBP. Doxycycline is non-inferior to guideline-directed therapies regarding safety and efficacy in primary and secondary prophylaxis for SBP.
Detailed description
Spontaneous bacterial peritonitis (SBP) is a common and serious complication in cirrhotic patients with a reported mortality rate of 20 to 30%.1-3 A SBP diagnosis requires abdominal paracentesis and is made in the presence of an elevated ascitic fluid absolute polymorphonuclear leukocyte (PMN) count without an evident intra-abdominal, surgically treatable source of infection.2,3 Common pathogens associated with SBP are Gram-negative colonic organisms. However, in recent years, Gram-positive pathogens have become more common, suggesting the need to evaluate SBP management.1,4-6 The recurrence rate of SBP after an initial episode has been reported to be as high as 70%.1-3 Currently, the American Association for the Study of Liver Disease (AASLD) and European Association for the Study of the Liver (EASL) guidelines recommend the use of sulfamethoxazole/trimethoprim, norfloxacin, or ciprofloxacin for the prevention of recurrent SBP. Fluoroquinolones as a class have had increased black box warnings in recent years, making ciprofloxacin fall out of favor for long-term prophylaxis.5 Sulfamethoxazole/trimethoprim is extensively metabolized by the liver and is contraindicated in marked liver impairment.8 Therefore, it is necessary to search for a prophylaxis alternative with similar efficacy and a better safety profile.
Doxycycline is a broad-spectrum antibiotic that covers Gram-positive bacteria, including Streptococcus spp., resistant strains of Staphylococcus and Enterococcus, and Gram-negative bacteria, including Enterobacteriaceae. One randomized trial in cirrhotic patients with a previous episode of SBP showed that doxycycline was associated with a reduction in inflammatory markers, such as interleukin-6 and C-reactive protein, suggesting potential benefits of doxycycline in this patient population.7 At Methodist Dallas Medical Center (MDMC) and the Liver Institute at MDMC, doxycycline has been utilized for both primary and secondary prevention of SBP. In order to compare doxycycline with guideline-directed therapies for SBP prevention in cirrhotic patients, a retrospective, cohort study was designed to review patients who meet the criteria from July 2014 to July 2018. This study aims to compare the efficacy of doxycycline with that of guideline recommended therapies for primary and secondary SBP prophylaxis, the safety of doxycycline with that of guideline recommended therapies for primary and secondary SBP prophylaxis, and identify the association between chemoprophylaxis and the risk of infections from multidrug resistant organisms (MDROs) in SBP.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized at MDMC at the Liver Institute Clinic with a diagnosis of SBP based on ascitic fluid PMN count greater than 250 cells/mm3 from July 2014 to July 2018.
Key inclusion criteria (3 listed)
- Patients ≥ 18 year-old with refractory ascites who are candidates for SBP prophylaxis per clinician's decision
- Patients diagnosed with cirrhosis based on clinical criteria
- Patients with a diagnosis of SBP confirmed by paracentesis
Key exclusion criteria (3 listed)
- Patients who have secondary peritonitis other than SBP
- Patients who have a history of liver transplant prior to the initial episode of SBP
- Patients with incomplete medical records
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 |
|---|---|---|
| doxycyclinea tetracycline antibiotic that fights bacteria in the body. | Drug | – |
Primary outcome
Occurrence of reported SBP
Time frame: July 2014 to July 2018
Occurrence of reported SBP within 1-year of chemoprophylaxis initiation
8 secondary outcomes
Incidences of death
Time frame: July 2014 to July 2018
Incidences of Liver transplant
Time frame: July 2014 to July 2018
Incidences of bacteremia
Time frame: July 2014 to July 2018
Hospitalizations and ED visits due to AKI
Time frame: July 2014 to July 2018
Hospitalizations and ED visits due to Clostridioides difficile infection
Time frame: July 2014 to July 2018
Hospitalizations and ED visits due to diarrhea
Time frame: July 2014 to July 2018
Hospitalizations and ED visits due to hyperkalemia
Time frame: July 2014 to July 2018
Rate of infection with MDRO
Time frame: July 2014 to July 2018
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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.
Jessica Rago, PharmD principal investigator
The Methodist Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cirrhosis and Spontaneous Bacterial Peritonitis, run by Methodist Health System 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 3 inclusion and 3 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 20 Mar 2026. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Occurrence of reported SBP (time frame: July 2014 to July 2018). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Mar 2026.