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. 2020 Jan 16;2020(1):CD013125. doi: 10.1002/14651858.CD013125.pub2

Lontos 2014.

Methods Randomised clinical trial
Participants Country: Australia
Period of recruitment: 2005
Number randomised: 80
Postrandomisation dropouts: not stated
Revised sample size: 80
Mean age (years): 53
Females: 20 (25.0%)
Presence of other features of decompensation (hepatorenal syndrome, hepatic encephalopathy, or variceal bleeding): not stated
Ascites with low protein: 69 (86.3%)
Primary prophylaxis: 59 (73.8%)
Alcohol‐related cirrhosis: 34 (42.5%)
Viral‐related cirrhosis: 29 (36.3%)
Autoimmune disease‐related cirrhosis (e.g. PSC, PBC, AIH): not stated
Other causes for cirrhosis: 17 (21.3%)
Treated for ascites in addition to antibiotics (e.g. albumin or diuretics): not stated
Exclusion criteria:

  • allergies to sulphur‐containing drugs or quinolones

  • documented failure of either study drug in the past while on prophylaxis

  • antibiotic therapy in the 2 weeks prior to the inclusion

  • severe renal impairment

  • hepatocellular carcinoma or other conditions with an expected survival < 3 months

  • current bacterial infection

  • secondary peritonitis

  • active autoimmune hepatitis

  • HIV infection

  • previous liver transplantation
Interventions Participants randomly assigned to 2 groups.
Group 1: sulfamethoxazole + trimethoprim (n = 40)
Further details: sulfamethoxazole 160 mg + trimethoprim 800 mg daily (duration not stated, but probably until follow‐up)
Group 2: norfloxacin (n = 40)
Further details: norfloxacin 400 mg daily (duration not stated, but probably until follow‐up)
Outcomes Outcomes reported: all‐cause mortality; number of any adverse events per participant; liver transplantation; proportion with spontaneous bacterial peritonitis (as per definition)
Follow‐up (months): 12
Notes Trial name/trial registry number: ACTRN12605000560695
Attempted to contact authors in November 2018, but received no replies.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Randomization was achieved with computer generated and sealed in opaque envelopes."
Allocation concealment (selection bias) Low risk Quote: "Randomization was achieved with computer generated and sealed in opaque envelopes."
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Quote: "The study was non‐blinded to both investigators and patients."
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Quote: "The study was non‐blinded to both investigators and patients."
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Comment: information not available
Selective reporting (reporting bias) Low risk Comment: protocol not available, but authors reported mortality and adverse events adequately.
Other bias Low risk Comment: no other bias noted