Doxycycline for the Prevention of Spontaneous Bacterial Peritonitis
1 other identifier
observational
841
1 country
1
Brief 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. Doxycycline is non-inferior to guideline-directed therapies regarding safety and efficacy in primary and secondary prophylaxis for SBP.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2019
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 4, 2019
CompletedStudy Start
First participant enrolled
November 4, 2019
CompletedFirst Posted
Study publicly available on registry
November 6, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 7, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 7, 2020
CompletedMarch 20, 2026
March 1, 2024
9 months
November 4, 2019
March 19, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Occurrence of reported SBP
Occurrence of reported SBP within 1-year of chemoprophylaxis initiation
July 2014 to July 2018
Secondary Outcomes (8)
Incidences of death
July 2014 to July 2018
Incidences of Liver transplant
July 2014 to July 2018
Incidences of bacteremia
July 2014 to July 2018
Hospitalizations and ED visits due to AKI
July 2014 to July 2018
Hospitalizations and ED visits due to Clostridioides difficile infection
July 2014 to July 2018
- +3 more secondary outcomes
Interventions
a tetracycline antibiotic that fights bacteria in the body.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Methodist Dallas Medical Center
Dallas, Texas, 75203, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jessica Rago, PharmD
The Methodist Hospital Research Institute
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 4, 2019
First Posted
November 6, 2019
Study Start
November 4, 2019
Primary Completion
August 7, 2020
Study Completion
August 7, 2020
Last Updated
March 20, 2026
Record last verified: 2024-03