A Phase 3 interventional study of Co-Trimoxazole 960Mg Dispersible Tablet and Placebo oral tablet in Spontaneous Bacterial Peritonitis, sponsored by University College, London. Active, not recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-18.
Sponsored by University College, London · Phase 3, Interventional, and Prevention
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
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167 studies on the registry are indexed under Peritonitis; 23 are open to participants now.
This study's enrollment of 442 is above the median of 79 across 106 interventional studies indexed under Peritonitis.
Browse Peritonitis studies →University College, London is the lead sponsor of 651 studies on the registry; 149 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
Patients with pathological blood count changes
Any clinical condition which the investigator considers would make the patient unsuitable for the trial.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Co-trimoxazole, 960mg capsule oral tablet, to be taken daily for 18 months
Drug: Co-Trimoxazole 960Mg Dispersible Tablet
Placebo, 960mg capsule oral tablet, to be taken daily for 18 months
Drug: Placebo oral tablet
Antibiotic prophylaxis of Spontaneous Bacterial Peritonitis
Placebo
Also known as: Placebo
Overall Survival
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)
Spontaneous Bacterial peritonitis
Time to first incidence of spontaneous bacterial peritonitis (SBP)
Time frame: Minimum period of 18 months from randomisation
Hospital admissions
Hospital admission rates
Time frame: Minimum period of 18 months from randomisation
C. difficile-associated diarrhoea
Incidence of C. difficile-associated diarrhoea
Time frame: 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.
Time frame: Minimum period of 18 months from randomisation
Cirrhosis related events
Incidence of other cirrhosis related events (e.g. variceal haemorrhage)
Time frame: 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
Time frame: Minimum period of 18 months from randomisation
Anti-microbial resistance
Incidence of anti-microbial resistance
Time frame: Minimum period of 18 months from randomisation
Liver transplantation
Incidence of liver transplantation
Time frame: 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.
Time frame: Minimum period of 18 months from randomisation
Safety and treatment-related serious adverse events
Safety and treatment-related serious adverse events
Time frame: Minimum period of 18 months from randomisation
Treatment adherence
Treatment adherence (assessed by MARS questionnaire)
Time frame: Minimum period of 18 months from randomisation
Health-related quality of life
Health-related quality of life assessed using EQ-5D-5L questionnaire
Time frame: Minimum period of 18 months from randomisation
Health and social care
Health and social care resource use assessed using Hospital Episode Statistics (HES) database
Time frame: 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)
Time frame: 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
Time frame: Minimum period of 18 months from randomisation
Transjugular intrahepatic portosystemic shunt (TIPS) insertion
Incidence of Transjugular intrahepatic portosystemic shunt (TIPS) insertion
Time frame: Minimum period of 18 months from randomisation
Plan to share: No
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This study is active, not recruiting, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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