ASEPTIC

• Research type

  Research Study

• Full title

  ASEPTIC: Primary Antibiotic prophylaxis using co-trimoxazole to prevent SpontanEous bacterial PeritoniTIs in Cirrhosis

• IRAS ID

  262176

• Contact name

  Alastair O’Brien

• Eudract number

  2019-000581-38

• Duration of Study in the UK

  5 years, 0 months, 0 days

• Research summary

  Liver disease is a common cause of death and the three major causes are excessive alcohol drinking, obesity or infection with viral hepatitis. It develops over 15-30 years and causes irreversible liver scarring, cirrhosis. Some patients develop features of advanced liver disease - a yellow skin, vomiting of blood or fluid in their abdomen and this affects 6000 people a year in Britain. They are very vulnerable to infection with bacteria because of their weak immune systems. These infections almost always require hospital admission and worsen their liver disease.

  Spontaneous Bacterial Peritonitis (SBP) is the most common serious infection in people with cirrhosis and carries significant morbidity and mortality. While antibiotic prophylaxis to prevent further infection has been established for those with a prior episode of SBP there remains considerable uncertainty over primary prophylaxis for SBP. Indeed, antibiotics prophylaxis are only established for patients with a prior episode of SBP. However, more than 90% of SBPs have no previous episodes, nevertheless there is no consensus on prophylaxis treatment for patients without primary SBP. Co-trimoxazole is cost-effective, well tolerated, and presents less concern over antimicrobial resistance (AMR) risk than other prophylaxis antibiotics.

  The aim of the ASEPTIC trial is to determine the effectiveness of the antibiotic prophylaxis co-trimoxazole for adults with cirrhosis and ascites but no previous episode of SBP in order to prevent the development of SBP.

  The ASPEPTIC trial will recruit 548 people with cirrhosis and ascites but no SBP from 30 hospitals. Each will be given a pill once a day. These pills will look identical but half will be an antibiotic and half an inactive tablet, a placebo. Participants will take the medication for 24 months.

  The results of the trial should tell us if co-trimoxazole prophylaxis prevents SBP effectively and safely.

• REC name

  South Central - Oxford B Research Ethics Committee

• REC reference

  19/SC/0311

• Date of REC Opinion

  20 Jun 2019

• REC opinion

  Favourable Opinion