Daily Norfloxacin vs. Weekly Ciprofloxacin to Prevent Spontaneous Bacterial Peritonitis: A Randomized Controlled Trial

Hyung Joon Yim, Sang Jun Suh, Young Kul Jung, Sun Young Yim, Yeon Seok Seo, Yu Rim Lee, Soo Young Park, Jae Young Jang, Young Seok Kim, Hong Soo Kim, Byung Ik Kim, Soon-Ho Um

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

Objectives: For the prevention of spontaneous bacterial peritonitis (SBP) in cirrhotic patients with ascites, norfloxacin 400 mg per day is recommended as a standard regimen. This study aims to investigate whether ciprofloxacin once weekly administration is not inferior to norfloxacin once daily administration for the prevention of SBP. Methods: This is an investigator-initiated open-label randomized controlled trial conducted at seven tertiary hospitals in South Korea. Liver cirrhosis patients with ascites were screened, and enrolled in this randomized controlled trial if ascitic protein ≤1.5 g/dL or the presence of history of SBP. Ascitic polymorphonucleated cell count needed to be <250/mm3. Patients were randomly assigned into norfloxacin daily or ciprofloxacin weekly group, and followed-up for 12 months. Primary endpoint was the prevention of SBP. Results: One hundred twenty-four patients met enrollment criteria and were assigned into each group by 1:1 ratio (62:62). Seven patients in the norfloxacin group and five patients in the ciprofloxacin group were lost to follow-up. SBP developed in four patients (4/55) and in three patients (3/57) in each group, respectively (7.3% vs. 5.3%, P = 0.712). The transplant-free survival rates at 1 year were comparable between the groups (72.7% vs. 73.7%, P = 0.970). Incidence of infectious complication, hepatorenal syndrome, hepatic encephalopathy, and variceal bleeding rates were not significantly different (all P = ns). The factors related to survival were models representing underlying liver function. Conclusion: Once weekly ciprofloxacin was as effective as daily norfloxacin for the prevention of SBP in cirrhotic patients with ascites.

Original languageEnglish
Pages (from-to)1-10
Number of pages10
JournalAmerican Journal of Gastroenterology
DOIs
Publication statusAccepted/In press - 2018 Jun 27

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Norfloxacin
Ciprofloxacin
Peritonitis
Randomized Controlled Trials
Ascites
Hepatorenal Syndrome
Republic of Korea
Hepatic Encephalopathy
Lost to Follow-Up
Tertiary Care Centers
Liver Cirrhosis
Survival Rate
Cell Count
Research Personnel
Hemorrhage
Transplants
Survival

ASJC Scopus subject areas

  • Hepatology
  • Gastroenterology

Cite this

Daily Norfloxacin vs. Weekly Ciprofloxacin to Prevent Spontaneous Bacterial Peritonitis : A Randomized Controlled Trial. / Yim, Hyung Joon; Suh, Sang Jun; Jung, Young Kul; Yim, Sun Young; Seo, Yeon Seok; Lee, Yu Rim; Park, Soo Young; Jang, Jae Young; Kim, Young Seok; Kim, Hong Soo; Kim, Byung Ik; Um, Soon-Ho.

In: American Journal of Gastroenterology, 27.06.2018, p. 1-10.

Research output: Contribution to journalArticle

Yim, Hyung Joon ; Suh, Sang Jun ; Jung, Young Kul ; Yim, Sun Young ; Seo, Yeon Seok ; Lee, Yu Rim ; Park, Soo Young ; Jang, Jae Young ; Kim, Young Seok ; Kim, Hong Soo ; Kim, Byung Ik ; Um, Soon-Ho. / Daily Norfloxacin vs. Weekly Ciprofloxacin to Prevent Spontaneous Bacterial Peritonitis : A Randomized Controlled Trial. In: American Journal of Gastroenterology. 2018 ; pp. 1-10.
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abstract = "Objectives: For the prevention of spontaneous bacterial peritonitis (SBP) in cirrhotic patients with ascites, norfloxacin 400 mg per day is recommended as a standard regimen. This study aims to investigate whether ciprofloxacin once weekly administration is not inferior to norfloxacin once daily administration for the prevention of SBP. Methods: This is an investigator-initiated open-label randomized controlled trial conducted at seven tertiary hospitals in South Korea. Liver cirrhosis patients with ascites were screened, and enrolled in this randomized controlled trial if ascitic protein ≤1.5 g/dL or the presence of history of SBP. Ascitic polymorphonucleated cell count needed to be <250/mm3. Patients were randomly assigned into norfloxacin daily or ciprofloxacin weekly group, and followed-up for 12 months. Primary endpoint was the prevention of SBP. Results: One hundred twenty-four patients met enrollment criteria and were assigned into each group by 1:1 ratio (62:62). Seven patients in the norfloxacin group and five patients in the ciprofloxacin group were lost to follow-up. SBP developed in four patients (4/55) and in three patients (3/57) in each group, respectively (7.3{\%} vs. 5.3{\%}, P = 0.712). The transplant-free survival rates at 1 year were comparable between the groups (72.7{\%} vs. 73.7{\%}, P = 0.970). Incidence of infectious complication, hepatorenal syndrome, hepatic encephalopathy, and variceal bleeding rates were not significantly different (all P = ns). The factors related to survival were models representing underlying liver function. Conclusion: Once weekly ciprofloxacin was as effective as daily norfloxacin for the prevention of SBP in cirrhotic patients with ascites.",
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T1 - Daily Norfloxacin vs. Weekly Ciprofloxacin to Prevent Spontaneous Bacterial Peritonitis

T2 - A Randomized Controlled Trial

AU - Yim, Hyung Joon

AU - Suh, Sang Jun

AU - Jung, Young Kul

AU - Yim, Sun Young

AU - Seo, Yeon Seok

AU - Lee, Yu Rim

AU - Park, Soo Young

AU - Jang, Jae Young

AU - Kim, Young Seok

AU - Kim, Hong Soo

AU - Kim, Byung Ik

AU - Um, Soon-Ho

PY - 2018/6/27

Y1 - 2018/6/27

N2 - Objectives: For the prevention of spontaneous bacterial peritonitis (SBP) in cirrhotic patients with ascites, norfloxacin 400 mg per day is recommended as a standard regimen. This study aims to investigate whether ciprofloxacin once weekly administration is not inferior to norfloxacin once daily administration for the prevention of SBP. Methods: This is an investigator-initiated open-label randomized controlled trial conducted at seven tertiary hospitals in South Korea. Liver cirrhosis patients with ascites were screened, and enrolled in this randomized controlled trial if ascitic protein ≤1.5 g/dL or the presence of history of SBP. Ascitic polymorphonucleated cell count needed to be <250/mm3. Patients were randomly assigned into norfloxacin daily or ciprofloxacin weekly group, and followed-up for 12 months. Primary endpoint was the prevention of SBP. Results: One hundred twenty-four patients met enrollment criteria and were assigned into each group by 1:1 ratio (62:62). Seven patients in the norfloxacin group and five patients in the ciprofloxacin group were lost to follow-up. SBP developed in four patients (4/55) and in three patients (3/57) in each group, respectively (7.3% vs. 5.3%, P = 0.712). The transplant-free survival rates at 1 year were comparable between the groups (72.7% vs. 73.7%, P = 0.970). Incidence of infectious complication, hepatorenal syndrome, hepatic encephalopathy, and variceal bleeding rates were not significantly different (all P = ns). The factors related to survival were models representing underlying liver function. Conclusion: Once weekly ciprofloxacin was as effective as daily norfloxacin for the prevention of SBP in cirrhotic patients with ascites.

AB - Objectives: For the prevention of spontaneous bacterial peritonitis (SBP) in cirrhotic patients with ascites, norfloxacin 400 mg per day is recommended as a standard regimen. This study aims to investigate whether ciprofloxacin once weekly administration is not inferior to norfloxacin once daily administration for the prevention of SBP. Methods: This is an investigator-initiated open-label randomized controlled trial conducted at seven tertiary hospitals in South Korea. Liver cirrhosis patients with ascites were screened, and enrolled in this randomized controlled trial if ascitic protein ≤1.5 g/dL or the presence of history of SBP. Ascitic polymorphonucleated cell count needed to be <250/mm3. Patients were randomly assigned into norfloxacin daily or ciprofloxacin weekly group, and followed-up for 12 months. Primary endpoint was the prevention of SBP. Results: One hundred twenty-four patients met enrollment criteria and were assigned into each group by 1:1 ratio (62:62). Seven patients in the norfloxacin group and five patients in the ciprofloxacin group were lost to follow-up. SBP developed in four patients (4/55) and in three patients (3/57) in each group, respectively (7.3% vs. 5.3%, P = 0.712). The transplant-free survival rates at 1 year were comparable between the groups (72.7% vs. 73.7%, P = 0.970). Incidence of infectious complication, hepatorenal syndrome, hepatic encephalopathy, and variceal bleeding rates were not significantly different (all P = ns). The factors related to survival were models representing underlying liver function. Conclusion: Once weekly ciprofloxacin was as effective as daily norfloxacin for the prevention of SBP in cirrhotic patients with ascites.

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