Spontaneous Bacterial PeritonitisPhase 3ASEPTICNCT04395365
Primary Antibiotic Prophylaxis Using Co-trimoxazole to Prevent Spontaneous Bacterial Peritonitis in Cirrhosis
A Phase 3 study testing Co-Trimoxazole 960Mg Dispersible Tablet in people with Spontaneous Bacterial Peritonitis, run by University College, London at 1 site in United Kingdom.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spontaneous Bacterial Peritonitis
- What is being tested?
- Co-Trimoxazole 960Mg Dispersible Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 442 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Jun 2019to Oct 2025
- Phase
- Phase 3
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Patient at least 18 years of age
- Documented informed consent to participate
Who cannot join
- 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).
- Patients receiving palliative care with an expected life expectancy of <8 weeks
- Allergic to co-trimoxazole, trimethoprim or sulphonamides
- Pregnant or lactating mothers
- Patient enrolled in a clinical trial of investigational medicinal products (IMPs) that would impact on their participation in the study
- Patients with serum potassium (>5.5 mmol/L) related to pre-existing kidney disease which cannot be reduced*
Show all 19Show fewer
- Patients receiving antibiotic prophylaxis (except for rifaximin)*
- Patients with long-term ascites drains*
- Women of child-bearing potential and males with a partner of child-bearing potential without effective contraception for the duration of trial treatment
- Patients with pathological blood count changes
- Patients with haemoglobin (Hb) <70g/L*
- Granulocytopenia defined as absolute neutrophil counts of less than 500 cells per microliter*
- Severe thrombocytopenia with a platelet count <30 x109 /L*
- Patients with severe renal impairment, with eGFR <15 ml/min*
- Patients with skin conditions: exudative erythema multiform, Stevens-Johnson syndrome, toxic epidermal necrolysis and drug eruption with eosinophilia and systemic symptoms
- Patients with congenital conditions: congenital glucose-6-Phosphate dehydrogenase deficiency of the erythrocytes, haemoglobin anomalies such as Hb Köln and Hb Zürich
- Patients with acute porphyria
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the detailed description
See above
- Conditions
- Spontaneous Bacterial Peritonitis
- Being tested
- Co-Trimoxazole 960Mg Dispersible Tablet, Placebo oral tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Co-Trimoxazole 960Mg Dispersible TabletDrug
Antibiotic prophylaxis of Spontaneous Bacterial Peritonitis
Placebo oral tabletDrug
Also called Placebo
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Co-trimoxazole | Experimental | Co-trimoxazole, 960mg capsule oral tablet, to be taken daily for 18 months Receives: Drug: Co-Trimoxazole 960Mg Dispersible Tablet |
| Placebo | Placebo comparator | Placebo, 960mg capsule oral tablet, to be taken daily for 18 months Receives: Drug: Placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Overall Survival
Measured: 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)
Secondary outcomes (16)
Spontaneous Bacterial peritonitis
Time to first incidence of spontaneous bacterial peritonitis (SBP)
Measured: Minimum period of 18 months from randomisation
Hospital admissions
Hospital admission rates
Measured: Minimum period of 18 months from randomisation
C. difficile-associated diarrhoea
Incidence of C. difficile-associated diarrhoea
Measured: Minimum period of 18 months from randomisation
Infections other than spontaneous bacterial peritonitis with hospital admission
Incidence of infections other than spontaneous bacterial peritonitis with hospital admission.
Measured: Minimum period of 18 months from randomisation
Cirrhosis related events
Incidence of other cirrhosis related events (e.g. variceal haemorrhage)
Measured: Minimum period of 18 months from randomisation
Renal dysfunction
Incidence of renal dysfunction with creatinine >133 μmol/L (1.5mg/dL) at any point during hospital admission
Measured: Minimum period of 18 months from randomisation
Anti-microbial resistance
Incidence of anti-microbial resistance
Measured: Minimum period of 18 months from randomisation
Liver transplantation
Incidence of liver transplantation
Measured: Minimum period of 18 months from randomisation
Liver disease assessed by increase in MELD score
Progression of liver disease assessed by increase in MELD score between baseline and end of trial follow up.
Measured: Minimum period of 18 months from randomisation
Safety and treatment-related serious adverse events
Safety and treatment-related serious adverse events
Measured: Minimum period of 18 months from randomisation
Treatment adherence
Treatment adherence (assessed by MARS questionnaire)
Measured: Minimum period of 18 months from randomisation
Health-related quality of life
Health-related quality of life assessed using EQ-5D-5L questionnaire
Measured: Minimum period of 18 months from randomisation
Health and social care
Health and social care resource use assessed using Hospital Episode Statistics (HES) database
Measured: Minimum period of 18 months from randomisation
Mean incremental cost per quality adjusted life year gained (QALY)
Mean incremental cost per quality adjusted life year gained (QALY)
Measured: Minimum period of 18 months from randomisation
Incidence of resolution of ascites with diuretic treatment not required for 6 months
Incidence of resolution of ascites with diuretic treatment not required for 6 months
Measured: Minimum period of 18 months from randomisation
Transjugular intrahepatic portosystemic shunt (TIPS) insertion
Incidence of Transjugular intrahepatic portosystemic shunt (TIPS) insertion
Measured: Minimum period of 18 months from randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2020
- Study start30 Jun 2019
- Primary completionOct 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spontaneous Bacterial PeritonitisStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 442 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04395365
- Sponsor's protocol ID
- 17/0894
- Acronym
- ASEPTIC
- Status last verified
- Nov 2023
- First submitted
- 18 Apr 2020
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Antibiotic Prophylaxis Using Co-trimoxazole to Prevent Spontaneous Bacterial Peritonitis in Cirrhosis
- ClinicalTrials.gov ID
- NCT04395365
- Acronym / sponsor ID
- ASEPTIC / 17/0894
- Conditions
- Spontaneous Bacterial Peritonitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 442 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- 30 Jun 2019 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 20 May 2020 (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.
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
Detailed description
See above
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Co-trimoxazole | Experimental | Drug: Co-Trimoxazole 960Mg Dispersible TabletCo-trimoxazole, 960mg capsule oral tablet, to be taken daily for 18 months |
| Placebo | Placebo comparator | Drug: Placebo oral tabletPlacebo, 960mg capsule oral tablet, to be taken daily for 18 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
- Patient at least 18 years of age
- Documented informed consent to participate
Key exclusion criteria (19 listed)
- 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).
- Patients receiving palliative care with an expected life expectancy of <8 weeks
- Allergic to co-trimoxazole, trimethoprim or sulphonamides
- Pregnant or lactating mothers
- Patient enrolled in a clinical trial of investigational medicinal products (IMPs) that would impact on their participation in the study
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 |
|---|---|---|
| Co-Trimoxazole 960Mg Dispersible TabletAntibiotic prophylaxis of Spontaneous Bacterial Peritonitis | Drug | Co-trimoxazole |
| Placebo oral tabletAlso: PlaceboPlacebo | Drug | Placebo |
Primary outcome
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
16 secondary outcomes
Spontaneous Bacterial peritonitis
Time frame: Minimum period of 18 months from randomisation
Hospital admissions
Time frame: Minimum period of 18 months from randomisation
C. difficile-associated diarrhoea
Time frame: Minimum period of 18 months from randomisation
Infections other than spontaneous bacterial peritonitis with hospital admission
Time frame: Minimum period of 18 months from randomisation
Cirrhosis related events
Time frame: Minimum period of 18 months from randomisation
Renal dysfunction
Time frame: Minimum period of 18 months from randomisation
Anti-microbial resistance
Time frame: Minimum period of 18 months from randomisation
Liver transplantation
Time frame: Minimum period of 18 months from randomisation
Liver disease assessed by increase in MELD score
Time frame: Minimum period of 18 months from randomisation
Safety and treatment-related serious adverse events
Time frame: Minimum period of 18 months from randomisation
Treatment adherence
Time frame: Minimum period of 18 months from randomisation
Health-related quality of life
Time frame: Minimum period of 18 months from randomisation
Health and social care
Time frame: Minimum period of 18 months from randomisation
Mean incremental cost per quality adjusted life year gained (QALY)
Time frame: Minimum period of 18 months from randomisation
Incidence of resolution of ascites with diuretic treatment not required for 6 months
Time frame: Minimum period of 18 months from randomisation
Transjugular intrahepatic portosystemic shunt (TIPS) insertion
Time frame: Minimum period of 18 months from randomisation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: No
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N-Acetylcysteine in the Management of Spontaneous Bacterial Peritonitis
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Not yet recruitingPhase 4
Clinical Study on the Effectiveness of Antibiotics Combined With Bifidobacterium Quadruple Live Tablets in Treating Cirrhosis With Spontaneous Bacterial Peritonitis and Preventing Recurrence
Cirrhosis With Spontaneous Bacterial Peritonitis
Not yet recruitingObservational study
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Spontaneous Bacterial Peritonitis
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Co-Trimoxazole 960Mg Dispersible Tablet in people with Spontaneous Bacterial Peritonitis, run by University College, London at 1 site in United Kingdom.
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 19 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: status not confirmed, as of the sponsor's last update on 18 Nov 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 Kingdom. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
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)). 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 18 Nov 2023.