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Cited by 258Liver Disease and TransplantationAntibiotics Pharmacokinetics and EfficacySepsis Diagnosis and Treatment

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Randomized, comparative study of oral ofloxacin versus intravenous cefotaxime in spontaneous bacterial peritonitis

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Navasa, M, Follo, A, Llovet, JM, Clemente, G, Vargas, V, Rimola, A, Marco, F, Guarner, C, Forne, M, Planas, R, Banares, R, Castells, L, Jimenez De Anta, MT, Arroyo, V, Rodes, J·1996·Gastroenterology
DOI 10.1016/s0016-5085(96)70069-0
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Abstract

Background & aims Treatment of spontaneous bacterial peritonitis currently involves intravenous antibiotic administration. To test the possibility of treating spontaneous bacterial peritonitis with oral antibiotics, oral ofloxacin was compared with intravenous cefotaxime in this infection.Methods One hundred twenty-three cirrhotics with uncomplicated spontaneous bacterial peritonitis (no septic shock, grade II-IV hepatic encephalopathy, serum creatinine level of > 3 mg/dL, and gastrointestinal hemorrhage or ileus) were randomly given oral ofloxacin (64 patients) or intravenous cefotaxime (59 patients).Results Infection resolution rate was 84% in the ofloxacin group and 85% in the cefotaxime group. Peak serum levels and trough serum and ascitic fluid levels of ofloxacin and cefotaxime measured on days 3 (23 patients) and 6 (11 patients) of therapy were greater than the minimal inhibitory concentration of isolated organisms. Hospital survival rate was 81% in each group of patients. Blood urea nitrogen and hepatic encephalopathy at diagnosis were associated with prognosis. None of the 36 nonazotemic patients with community-acquired spontaneous bacterial peritonitis and without hepatic encephalopathy developed complications during hospitalization, and all were alive at time of discharge.Conclusions Oral ofloxacin is as effective as intravenous cefotaxime in uncomplicated spontaneous bacterial peritonitis. Nonazotemic cirrhotic patients with uncomplicated community-acquired spontaneous bacterial peritonitis and without hepatic encephalopathy have an excellent prognosis and may be treated with oral ofloxacin without requiring hospitalization.

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Research works printed but not linked: 13

  1. receiving ofloxacin and cefotaxime, respectively, 1. Rimola A. Infections in liver disease. In: MacIntyre N, Benhamou and survival at the end of the hospital stay was 81% in JP, Bircher J, Rizzetto M, Rode ´s J, eds. Oxford textbook of clinical both groups of patients. hepatology. Oxford, England: Oxford University, 1991:1272- As in previous studies, 9,10 BUN at diagnosis was the 1284.
  2. Caly WR, Strauss E. A prospective study of bacterial infections hepatic encephalopathy (52 patients in our series; 26% in patients with cirrhosis. J Hepatol 1993;18:353-358. of the total number of patients with SBP considered for
  3. Felisart J, Rimola A, Arroyo V, Perez-Ayuso RM, Quintero E, Gine `s inclusion and 42% of the patients included) showed an P, Rode ´s J. Cefotaxime is more effective than is ampicillin-tobra- mycin in cirrhotics with severe infections. Hepatology 1985;5: excellent short-term prognosis. Only 1 of these 52 pa- 457-462. tients died during hospitalization, and the cause of death 5. Runyon BA, McHutchinson JG, Antillon MR, Akriviadis EA, Mon- (massive variceal bleeding) was probably unrelated to the tano AA. Short-course versus long-course antibiotic treatment of infection. The clinical course was particularly uneventful spontaneous bacterial peritonitis. A randomized controlled study of 100 patients. Gastroenterology 1991;100:1733-1742. in nonazotemic patients with community-acquired SBP
  4. Rimola A, Salmero ´n JM, Clemente G, Rodrigo L, Obrador A, Mi- without hepatic encephalopathy because none of these randa ML, Guarner C, Planas R, Sola ´R, Vargas V, Casafont F, patients developed major complications during hospital- Marco F, Navasa M, Ban ˜ares R, Arroyo V, Rode ´s J. Two different dosages of cefotaxime in the treatment of spontaneous bacterial ization and all were discharged alive after SBP resolution peritonitis in cirrhosis: results of a prospective, randomized, (Table 5). Our results therefore suggest that this selected multicenter study. Hepatology 1995;21:674-679.
  5. Conn HO, Fessel JM. Spontaneous bacterial peritonitis in cirrho- sis: variations on a theme. Medicine 1971;50:161-197.
  6. Correia JP, Conn HO. Spontaneous bacterial peritonitis in cirrho- ciprofloxacin and ofloxacin: effect of food and antacid intake. Rev Infect Dis 1988;10(Suppl 1):138-139. sis: endemic or epidemic? Med Clin North Am 1975;59:963- 981.
  7. Toledo C, Salmero ´n JM, Rimola A, Navasa M, Arroyo V, Llach J, Gine `s A, Gine `s P, Rode ´s J. Spontaneous bacterial peritonitis in 21. Chapin-Robertson K, Edberg SC. Measurements of antibiotics in human body fluids: techniques and significance. In: Lorian V, cirrhosis: predictive factors of infection resolution and survival in patients treated with cefotaxime. Hepatology 1993;17:251- ed. Antibiotics in laboratory medicine. 3rd ed. Baltimore, MD: Williams & Wilkins, 1991:295-366. 257.
  8. Silvain C, Bouquet S, Breux JP, Becq-Giraudon B, Beauchant M. Oral pharmacokinetics and ascitic fluid penetration of ofloxacin 12. Runyon BA, Hoefs JC. Culture-negative neutrocytic ascites: a vari- ant of spontaneous bacterial peritonitis. Hepatology 1984;4: in cirrhosis. Eur J Clin Pharmacol 1989;37:261-265.
  9. De Franchis R, Pascal JP, Ancona E, Burroughs AK, Henderson Oral disposition kinetics of ofloxacin in patients with compen- sated liver cirrhosis. Chemotherapy 1992;38:1-6.
  10. M, Fleig W, Groszmann R, Bosch J, Sauerbruch T, Soederlund C, Lebrec D, Soerensen TIA, Pagliaro L. Definitions, methodology 26. Gine `s P, Rimola A, Planas R, Vargas V, Marco F, Almela M, Forne ´ M, Miranda ML, Llach J, Salmero ´n JM, Esteve M, Marque ´s JM, and therapeutic strategies in portal hypertension: a consensus development workshop, Baveno, Lake Maggiore, Italy, April 5 and Jime ´nez de Anta MT, Arroyo V, Rode ´s J. Norfloxacin prevents spontaneous bacterial peritonitis recurrence in cirrhosis: results 6, 1990. J Hepatol 1992;15:256-261.
  11. Conn HO. Hepatic encephalopathy. In: Schiff L, Schiff ER, eds. of a double-blind, placebo-controlled trial. Hepatology 1990;12: 716-724. Diseases of the liver. 7th ed. Philadelphia: Lippincott, 1993: 1036-1060.
  12. Dupeyron C, Mangeney N, Sedrati L, Campillo B, Fouet P, Leluan G. Rapid emergence of quinolone resistance in cirrhotic patients 15. von Rosenstiel N, Adam D. Quinolone antibacterials: an update of their pharmacology and therapeutic use. Drugs 1994;47:872- treated with norfloxacin to prevent spontaneous bacterial perito- nitis. Antimicrob Agents Chemother 1994;38:340-344. 901.
  13. Ho ¨ffken G, Lode H, Wiley R, Glatzel TD, Sievers D, Olschewski Obrador, Pere Vaquer, Luis Rodrigo, Catalina Arnau, Jaime GarcıB a-Barbal, and Lionel Valde ´s for their participation in the study. T, Borner K, Koeppe T. Pharmacokinetics and bioavailability of / 5e12$$0010 09-04-96 13:47:54

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Authors
Navasa, M., Follo, A., Llovet, J., Clemente, G., Vargas, V, Rimola, A., Marco, F., Guarner, C., Forne, M., Planas, R., Banares, R., Castells, L., Jimenez De Anta, M., Arroyo, V, & Rodes, J.
Affiliations
  • University Hospital Mútua de Terrassa (ES)
  • Hospital General Universitario Gregorio Marañón (ES)
  • Vall d'Hebron Hospital Universitari (ES)
  • Hospital de Sant Pau (ES)
  • Hospital Universitari Germans Trias i Pujol (ES)
ORCID
Venue
Gastroenterology
Publisher
Elsevier BV
Published
1996-10
Volume
111
Issue
4
Pages
1011-1017
ISSN
0016-5085 (ISSN-L)
DOI
10.1016/s0016-5085(96)70069-0
OpenAlex
W2012654744
Cited by
258
References
7
Citations by year
2026: 1 · 2025: 2 · 2024: 5 · 2023: 1 · 2022: 5 · 2021: 6 · 2020: 1 · 2019: 18 · 2018: 10 · 2017: 5 · 2016: 10 · 2015: 7 · 2014: 8 · 2013: 10 · 2012: 8
FWCI
3.72
Type
journal article
Language
en
Open access
Licence
www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations
  • Gastroenterology (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Hepatology › Liver Disease and Transplantation
  • Health Sciences › Medicine › Pharmacology (medical) › Antibiotics Pharmacokinetics and Efficacy
  • Health Sciences › Medicine › Critical Care and Intensive Care Medicine › Sepsis Diagnosis and Treatment
Keywords
spontaneous bacterial peritonitis, oral antibiotic therapy, liver cirrhosis, hepatic encephalopathy, blood urea nitrogen, prognosis, community-acquired infections, hospital survival
MeSH terms
Administration, Oral, Adult, Aged, Aged, 80 and over, Anti-Infective Agents, Bacterial Infections, Cefotaxime, Cephalosporins, Female, Humans, Injections, Intravenous, Male, Middle Aged, Peritonitis, Ofloxacin

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