2018
DOI: 10.1053/j.gastro.2018.08.026
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Effects of Long-term Norfloxacin Therapy in Patients With Advanced Cirrhosis

Abstract: In a randomized controlled trial of patients with advanced cirrhosis without recent fluoroquinolone therapy, norfloxacin did not reduce 6-month mortality, estimated by the Kaplan-Meier method. Norfloxacin, however, appears to increase survival of patients with low ascites fluid protein concentrations. ClinicalTrials.gov ID: NCT01037959.

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Cited by 120 publications
(117 citation statements)
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“…Overall, these 10 trials included 910 patients. Out of 10 RCTs, four compared norfloxacin with placebo (included the study by Novella et al comparing continuous 1‐year norfloxacin treatment versus norfloxacin administered only during hospitalization), two compared ciprofloxacin with placebo, one norfloxacin with ciprofloxacin, one compared norfloxacin with rifaximin, and two compared norfloxacin with trimethoprim/sulfamethoxazole . SBP occurrence was reported in all the included trials, mortality rate was registered in eight RCTs, HRS occurrence in four RCTs …”
Section: Resultsmentioning
confidence: 99%
See 1 more Smart Citation
“…Overall, these 10 trials included 910 patients. Out of 10 RCTs, four compared norfloxacin with placebo (included the study by Novella et al comparing continuous 1‐year norfloxacin treatment versus norfloxacin administered only during hospitalization), two compared ciprofloxacin with placebo, one norfloxacin with ciprofloxacin, one compared norfloxacin with rifaximin, and two compared norfloxacin with trimethoprim/sulfamethoxazole . SBP occurrence was reported in all the included trials, mortality rate was registered in eight RCTs, HRS occurrence in four RCTs …”
Section: Resultsmentioning
confidence: 99%
“…Baseline patient characteristics and prognostic factors were comparably distributed in the active and comparator groups and across different trials. Three RCTs reported the proportion of patients with refractory ascites …”
Section: Resultsmentioning
confidence: 99%
“…In primary prophylaxis, norfloxacin is recommended when ascites fluid protein level is below 15 g/L in association with severe cirrhosis (Child‐Pugh score ≥9 and total bilirubin level ≥3 mg/dL (51 μmol/L), with either impaired renal function or hyponatraemia) . A French RCT compared norfloxacin to placebo in Child Pugh C patients without previous SBP . Six‐month mortality was only significantly lower in patients with low ascitic fluid protein levels (<15 g/L), confirming that primary prophylaxis should be restricted to the most severe patients.…”
Section: Optimal Management Of Ascitesmentioning
confidence: 99%
“…In these studies, prevention of infection was the primary outcome, and mortality (or HRS) was a secondary endpoint. Only one recent RCT investigates the effect of oral norfloxacin (versus placebo) on 6‐month survival in patients with decompensated (Child C) cirrhosis . Although there were no differences in overall mortality, survival was greater with norfloxacin in those with an ascites protein level less than 1 g/dL.…”
Section: Do Prophylactic Antibiotics Prevent Infections and The Downsmentioning
confidence: 99%