Trial reportHepatology international2016
Efficacy and safety of alternating norfloxacin and rifaximin as primary prophylaxis for spontaneous bacterial peritonitis in cirrhotic ascites: a prospective randomized open-label comparative multicenter study.
Trial report in Hepatology international, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 4 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
21 citing papers in PubMed, 4 syntheses or guidelines pooled it, 57 citations in OpenAlex.
- Norfloxacin versus alternative antibiotics for prophylaxis of spontaneous bacteria peritonitis in cirrhosis: a systematic review and meta-analysis.BMC infectious diseases · 2023Pooled it
- Antibiotics for prophylaxis of spontaneous bacterial peritonitis: systematic review & Bayesian network meta-analysis.Hepatology international · 2020Pooled it
- Antibiotic prophylaxis to prevent spontaneous bacterial peritonitis in people with liver cirrhosis: a network meta-analysis.The Cochrane database of systematic reviews · 2020Pooled it
- Austrian consensus guidelines on the management and treatment of portal hypertension (Billroth III).Wiener klinische Wochenschrift · 2017Guideline
- Antibiotic Stewardship in Cirrhosis: Current Recommendations and Clinical Challenges.United European gastroenterology journal · 2026Review
- Disease Modulating Agents in Cirrhosis.Clinics in liver disease · 2026Review
- Clinical, Microbiological, and Antibiotic Treatment Characteristics of Bacterial Infections in Patients with Liver Cirrhosis in China: A Multicenter Study.Journal of clinical and translational hepatology · 2025Article
- Antibiotics in Chronic Liver Disease and Their Effects on Gut Microbiota.Antibiotics (Basel, Switzerland) · 2023Review
- Austrian consensus on the diagnosis and management of portal hypertension in advanced chronic liver disease (Billroth IV).Wiener klinische Wochenschrift · 2023Article
- Gut Microbiota and Antibiotic Treatments for the Main Non-Oncologic Hepato-Biliary-Pancreatic Disorders.Antibiotics (Basel, Switzerland) · 2023Review
- Gut Microbiota and Infectious Complications in Advanced Chronic Liver Disease: Focus on Spontaneous Bacterial Peritonitis.Life (Basel, Switzerland) · 2023Review
- Evaluation of the current guidelines for antibacterial therapy strategies in patients with cirrhosis or liver failure.BMC infectious diseases · 2022Article
- Prevention of Cirrhosis Complications: Looking for Potential Disease Modifying Agents.Journal of clinical medicine · 2021Review
- The Use of Rifaximin in Patients With Cirrhosis.Hepatology (Baltimore, Md.) · 2021Review
- Liver Cirrhosis and Sarcopenia from the Viewpoint of Dysbiosis.International journal of molecular sciences · 2020Review
- Systemic review and network meta-analysis: Prophylactic antibiotic therapy for spontaneous bacterial peritonitis.World journal of hepatology · 2020Article
- Ascitic fluid polymorphic nuclear cell count impacts on outcome of cirrhotic patients with ascites.United European gastroenterology journal · 2019Article
- Management of Infectious Complications Associated with Acute-on-Chronic Liver Failure.Visceral medicine · 2018Review
- Spontaneous bacterial and fungal peritonitis in patients with liver cirrhosis: A literature review.World journal of hepatology · 2018Review
- Rifaximin versus norfloxacin for prevention of spontaneous bacterial peritonitis: a systematic review.BMJ open gastroenterology · 2017Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 5 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
aimPrimary prevention of spontaneous bacterial peritonitis (SBP) is an important strategy to reduce morbidity and mortality in cirrhotic patients with ascites. Efficacy and safety of alternating rifaximin and norfloxacin as primary prophylaxis is questionable.
methodsThree hundred thirty-four cirrhotic patients with high SAAG (≥1.1) ascites, protein level in ascitic fluid less than 1.5 g/dL with advanced liver disease (Child-Pugh score >9 points with serum bilirubin level >3 mg/dL) or renal impairment (serum creatinine level >1.2 mg/dL, blood urea nitrogen level >25 mg/dL, or serum sodium level <130 mEq/L) were included in an open-label, randomized study aimed at comparing alternating use of norfloxacin and rifaximin vs. norfloxacin or rifaximin alone as primary prophylaxis for SBP. Both intention-to-treat and per-protocol efficacy analyses were done after 6 months of treatment by assessment of ascitic fluid neutrophil count. Safety analysis was done for all intention-to-treat populations.
resultsAlternating norfloxacin and rifaximin showed superior prophylaxis by intention-to-treat (74.7 vs. 56.4% vs. 68.3%, p < 0.048). Pairwise analysis showed that alternating regimen had lower probability to develop SBP when compared to a norfloxacin-based regimen in intention-to-treat (p = 0.016) and per protocol analysis (p = 0.039). There was no difference among the studied groups regarding the incidence and severity of adverse events reported.
conclusionsAlternating norfloxacin- and rifaximin-based primary prophylaxis for SBP showed higher efficacy with the same safety profile when compared with monotherapy of norfloxacin.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.