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

Assem, Medhat; Elsabaawy, Maha; Abdelrashed, M.; Elemam, S.; Khodeer, Seham A; Hamed, Waleed; Abdel-Aziz, Azza; El-Azab, Gasser

doi:10.1007/s12072-015-9688-z

Cited by 54 publications

(48 citation statements)

References 44 publications

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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%

“…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%

“…Oral quinolones have been used for long period with favourable results in this subset of patients, as confirmed in a recent meta‐analysis; however, several concerns on the cost and safety profile of long‐term quinolones therapy along with the increasing risk of antibiotic resistance pushed to test other antimicrobial agents such as rifaximin or trimethoprim/sulfamethoxazole …”

Section: Discussionmentioning

confidence: 99%

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Comparative efficacy of long‐term antibiotic treatments in the primary prophylaxis of spontaneous bacterial peritonitis

Facciorusso

Papagiouvanni

Cela

et al. 2019

Liver International

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Background & Aims: Several antibiotic treatments aiming to prevent spontaneous bacterial peritonitis (SBP) in cirrhotic patients with low-protein content in ascitic fluid have been tested; however, there are limited data on the comparative efficacy of these regimens. We assessed their comparative efficacy through a network metaanalysis and using GRADE criteria to appraise quality of evidence.Methods: Through literature review through October 2018, we identified 10 randomized controlled trials comparing antibiotic treatments (norfloxacin, ciprofloxacin, trimethoprim/sulfamethoxazole and rifaximin) with each other or placebo. Primary outcome was SBP occurrence, with mortality rate and rate of other infections as secondary outcomes. Results:In comparison with placebo, moderate quality evidence supports the use of norfloxacin and ciprofloxacin in primary prophylaxis of SBP (risk ratio 0.23; 95% CI, 0.09-0.56; P = 0.001 and 0.23; 0.07-0.79; P = 0.02 respectively) while only low quality evidence suggests superiority of rifaximin (risk ratio 0.15; 0.05-0.42). When antimicrobial agents were compared to each other, no significant difference was found.With regard to mortality, moderate quality supports the superiority of norfloxacin over placebo (risk ratio, 0.68; 95% CI, 0.47-0.99; P = 0.04), while ciprofloxacin and rifaximin showed only a non-significant benefit and no significant difference was found in the other comparisons. None of the tested antibiotics proved to significantly decrease the rate of other infections.Conclusions: Norfloxacin appears to have significant benefit both in terms of SBP prevention and mortality; ciprofloxacin represents a valuable option although without a clear survival benefit. Rifaximin shows interesting results but needs to be tested in further trials. K E Y W O R D S cirrhosis, GRADE, liver, norfloxacin | 1449 FACCIORUSSO et Al.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Comparative efficacy of long‐term antibiotic treatments in the primary prophylaxis of spontaneous bacterial peritonitis

Facciorusso

Papagiouvanni

Cela

et al. 2019

Liver International

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“…Although studies published so far suggest an improvement of the SBP rate, even in comparison to norfloxacin [67], current evidence still does not allow its broad use. However, data are restricted to patients with hepatitis C and populations from a single country [68,69,70]. Uncertainty remains regarding its true beneficial effect; notably as other prospective cohort studies could not confirm the positive results [71].…”

Section: Treatmentmentioning

confidence: 99%

Management of Infectious Complications Associated with Acute-on-Chronic Liver Failure

Engelmann

Berg

2018

Visc Med

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Introduction: Acute-on-chronic liver failure (ACLF) is associated with a high susceptibility to infections leading to complications and poor prognosis. The sensitized immune system overwhelmingly responds to invading bacteria leading to organ damage. After resolution of infection or prolonged disease duration, the phagocytic system becomes irresponsive with a reduced bacterial clearance capacity promoting secondary infection. Methods: This review focuses on the best management strategies for patients with ACLF and infections. Using the following terms, an extensive literature research on the Medline database was performed: ‘acute-on-chronic liver failure', ‘infection', ‘ACLF', ‘bacteria', ‘multi-resistance'. Results: Analysis of the literature confirmed that delayed diagnosis and treatment of infections in patients with ACLF results in a poor prognosis. Patients with ACLF should be considered as having a potential infection and should undergo a complete screening for sepsis. Once biochemical analysis indicates a potential infection, such as abnormal levels of C-reactive protein and procalcitonin, antibiotic treatment should be initiated immediately without microbiological culture results. For community-acquired infections third-generation cephalosporins are still the first choice, whereas in the nosocomial setting antibiotics with broader spectrum, such as piperacillin/combactam or carbapenems ± glycopeptides, are preferred. The patient should be re-assessed 48 h after treatment initiation in order to tailor the treatment. Non-response is suspicious, likely due to bacterial resistance or fungal infection, which should be considered when choosing further treatment strategies. Albumin substitution to prevent hepatorenal syndrome and to improve patients' outcome is mandatory in patients with spontaneous bacterial peritonitis. Prophylactic antibiotic therapy is suitable to prevent infections in high-risk patients. Conclusion: The screening for infections and its treatment is an essential part of managing patients with ACLF. In order to improve patients' prognosis, antibiotic treatment should be initiated once an infection is suspected. However, preventive strategies are already established and should be applied according to the guidelines.

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“…For this reason, it is appropriate for this subgroup of patients to make long-term use of norloxacin, especially if they are on the waiting list for a liver transplant [19].…”

Section: Primary Sbp Prophylaxismentioning

confidence: 99%

Introductory Chapter: Treatment of Ascites Associated with Cirrhosis and Its Complications

Rodrigo¹

2017

Ascites - Physiopathology, Treatment, Complications and Prognosis

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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

Abstract: Alternating norfloxacin- and rifaximin-based primary prophylaxis for SBP showed higher efficacy with the same safety profile when compared with monotherapy of norfloxacin.

Cited by 54 publications

References 44 publications

Comparative efficacy of long‐term antibiotic treatments in the primary prophylaxis of spontaneous bacterial peritonitis

Comparative efficacy of long‐term antibiotic treatments in the primary prophylaxis of spontaneous bacterial peritonitis

Management of Infectious Complications Associated with Acute-on-Chronic Liver Failure

Introductory Chapter: Treatment of Ascites Associated with Cirrhosis and Its Complications

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