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Primary Antibiotic Prophylaxis Using Co-trimoxazole to Prevent Spontaneous Bacterial Peritonitis in Cirrhosis (ASEPTIC)

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ClinicalTrials.gov Identifier: NCT04395365
Recruitment Status : Recruiting
First Posted : May 20, 2020
Last Update Posted : October 8, 2021
Sponsor:
Collaborator:
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
University College, London

Brief Summary:
A multicentre, interventional, double-blind, placebo-controlled, parallel-arm, phase 3, randomised controlled trial to evaluate the use of co-trimoxazole as primary prophylaxis for spontaneous bacterial peritonitis to improve overall survival

Condition or disease Intervention/treatment Phase
Spontaneous Bacterial Peritonitis Drug: Co-Trimoxazole 960Mg Dispersible Tablet Drug: Placebo oral tablet Phase 3

Detailed Description:
See above

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 432 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Primary Antibiotic Prophylaxis Using Co-trimoxazole to Prevent Spontaneous Bacterial Peritonitis in Cirrhosis
Actual Study Start Date : June 30, 2019
Estimated Primary Completion Date : October 2024
Estimated Study Completion Date : October 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
Experimental: Co-trimoxazole
Co-trimoxazole, 960mg capsule oral tablet, to be taken daily for 18 months
Drug: Co-Trimoxazole 960Mg Dispersible Tablet
Antibiotic prophylaxis of Spontaneous Bacterial Peritonitis

Placebo Comparator: Placebo
Placebo, 960mg capsule oral tablet, to be taken daily for 18 months
Drug: Placebo oral tablet
Placebo
Other Name: Placebo




Primary Outcome Measures :
  1. Overall Survival [ Time Frame: The maximum possible period of follow up will be 48 months (assuming a recruitment period of 30 months and 18 months treatment period for final patient recruited) ]
    Overall Survival


Secondary Outcome Measures :
  1. Spontaneous Bacterial peritonitis [ Time Frame: Minimum period of 18 months from randomisation ]
    Time to first incidence of spontaneous bacterial peritonitis (SBP)

  2. Hospital admissions [ Time Frame: Minimum period of 18 months from randomisation ]
    Hospital admission rates

  3. C. difficile-associated diarrhoea [ Time Frame: Minimum period of 18 months from randomisation ]
    Incidence of C. difficile-associated diarrhoea

  4. Infections other than spontaneous bacterial peritonitis with hospital admission [ Time Frame: Minimum period of 18 months from randomisation ]
    Incidence of infections other than spontaneous bacterial peritonitis with hospital admission.

  5. Cirrhosis related events [ Time Frame: Minimum period of 18 months from randomisation ]
    Incidence of other cirrhosis related events (e.g. variceal haemorrhage)

  6. Renal dysfunction [ Time Frame: Minimum period of 18 months from randomisation ]
    Incidence of renal dysfunction with creatinine >133 μmol/L (1.5mg/dL) at any point during hospital admission

  7. Anti-microbial resistance [ Time Frame: Minimum period of 18 months from randomisation ]
    Incidence of anti-microbial resistance

  8. Liver transplantation [ Time Frame: Minimum period of 18 months from randomisation ]
    Incidence of liver transplantation

  9. Liver disease assessed by increase in MELD score [ Time Frame: Minimum period of 18 months from randomisation ]
    Progression of liver disease assessed by increase in MELD score between baseline and end of trial follow up.

  10. Safety and treatment-related serious adverse events [ Time Frame: Minimum period of 18 months from randomisation ]
    Safety and treatment-related serious adverse events

  11. Treatment adherence [ Time Frame: Minimum period of 18 months from randomisation ]
    Treatment adherence (assessed by MARS questionnaire)

  12. Health-related quality of life [ Time Frame: Minimum period of 18 months from randomisation ]
    Health-related quality of life assessed using EQ-5D-5L questionnaire

  13. Health and social care [ Time Frame: Minimum period of 18 months from randomisation ]
    Health and social care resource use assessed using Hospital Episode Statistics (HES) database

  14. Mean incremental cost per quality adjusted life year gained (QALY) [ Time Frame: Minimum period of 18 months from randomisation ]
    Mean incremental cost per quality adjusted life year gained (QALY)

  15. Incidence of resolution of ascites with diuretic treatment not required for 6 months [ Time Frame: Minimum period of 18 months from randomisation ]
    Incidence of resolution of ascites with diuretic treatment not required for 6 months

  16. Transjugular intrahepatic portosystemic shunt (TIPS) insertion [ Time Frame: Minimum period of 18 months from randomisation ]
    Incidence of Transjugular intrahepatic portosystemic shunt (TIPS) insertion



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Patients with Child-Pugh Class B or C cirrhosis and presence of ascites requiring any diuretic treatment or at least 1 or more paracentesis within 3 months prior to enrolment.
  2. Patient at least 18 years of age
  3. Documented informed consent to participate

Exclusion criteria:

  1. Patients with current or previous Spontaneous Bacterial Peritonitis (defined as ascitic polymorphonuclear (PMN) cell count >250/mm3 with either positive or negative ascitic fluid culture without evident intra-abdominal surgically treatable source of infection. A white cell count >500 cell/mm2 or positive microbial culture may be considered as evidence of previous SBP if the site PI considers this was in the context of a likely clinical diagnosis of SBP).
  2. Patients receiving palliative care with an expected life expectancy of <8 weeks
  3. Allergic to co-trimoxazole, trimethoprim or sulphonamides
  4. Pregnant or lactating mothers
  5. Patient enrolled in a clinical trial of investigational medicinal products (IMPs) that would impact on their participation in the study
  6. Patients with serum potassium (>5.5 mmol/L) related to pre-existing kidney disease which cannot be reduced*
  7. Patients receiving antibiotic prophylaxis (except for rifaximin)*
  8. Patients with long-term ascites drains*
  9. Women of child-bearing potential and males with a partner of child-bearing potential without effective contraception for the duration of trial treatment
  10. Patients with pathological blood count changes

    1. Patients with haemoglobin (Hb) <70g/L*
    2. Granulocytopenia defined as absolute neutrophil counts of less than 500 cells per microliter*
    3. Severe thrombocytopenia with a platelet count <30 x109 /L*
  11. Patients with severe renal impairment, with eGFR <15 ml/min*
  12. Patients with skin conditions: exudative erythema multiform, Stevens-Johnson syndrome, toxic epidermal necrolysis and drug eruption with eosinophilia and systemic symptoms
  13. Patients with congenital conditions: congenital glucose-6-Phosphate dehydrogenase deficiency of the erythrocytes, haemoglobin anomalies such as Hb Köln and Hb Zürich
  14. Patients with acute porphyria
  15. Any clinical condition which the investigator considers would make the patient unsuitable for the trial.

    • It is common for these investigations to change in patients with cirrhosis and long-term ascitic drains may be removed. Patients can be re-screened for eligibility if this occurs.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04395365


Contacts
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Contact: David Gear 02076705748 david.gear.16@ucl.ac.uk
Contact: Marisa Chau m.chau@ucl.ac.uk

Locations
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United Kingdom
Royal Free hospital Recruiting
Hampstead, London, United Kingdom, NW3 2QG
Principal Investigator: Alistair O'Brien         
Sponsors and Collaborators
University College, London
National Institute for Health Research, United Kingdom
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Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT04395365    
Other Study ID Numbers: 17/0894
First Posted: May 20, 2020    Key Record Dates
Last Update Posted: October 8, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Peritonitis
Intraabdominal Infections
Infections
Peritoneal Diseases
Digestive System Diseases
Trimethoprim, Sulfamethoxazole Drug Combination
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Anti-Bacterial Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents