Response-Guided Therapy With Cefotaxime, Ceftriaxone, or Ciprofloxacin for Spontaneous Bacterial Peritonitis: A Randomized Trial: A Validation Study of 2021 AASLD Practice Guidance for SBP
Authors and Affiliations
Authors and Affiliations
Yim, Hyung Joon MD, PhD1,*; Kim, Tae Hyung MD, PhD1,*; Suh, Sang Jun MD1; Yim, Sun Young MD, PhD1; Jung, Young Kul MD, PhD1; Seo, Yeon Seok MD, PhD1; Kang, Seong Hee MD, PhD1,2,3; Kim, Moon Young MD, PhD2; Baik, Soon Koo MD, PhD2; Kim, Hong Soo MD, PhD4; Kim, Young Seok MD, PhD4; Park, Soo Young MD, PhD5; Kim, Byung Ik MD, PhD6; Park, Jun Yong MD, PhD7; Heo, Jeong MD, PhD8; Sohn, Joo Hyun MD, PhD9; Heo, Nae-Yun MD, PhD10; Han, Kwang-Hyub MD, PhD7; Um, Soon Ho MD, PhD1
1Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea;
2Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju, Republic of Korea;
3Current affiliation: Inje University College of Medicine, Seoul, Republic of Korea;
4Department of Internal Medicine, Soonchunhyang University College of Medicine, Asan, Republic of Korea;
5Department of Internal Medicine, Kyungpook National University School of Medicine, Daegu, Republic of Korea;
6Department of Internal Medicine, Sungkyunkwan University College of Medicine, Seoul, Republic of Korea;
7Department of Internal Medicine, Yonsei University College of Medicine, Seoul, South Korea;
8Department of Internal Medicine, College of Medicine, Pusan National University, Busan, Republic of Korea;
9Department of Internal Medicine, Hanyang University College of Medicine, Seoul, Republic of Korea;
10Department of Internal Medicine, Inje University Haeundae Paik Hospital, Inje University College of Medicine, Busan, Republic of Korea.
*Hyung Joon Yim and Tae Hyung Kim equally contributed to this work.
Correspondence: and reprint request to: Soon Ho Um, MD, PhD.
Introduction: For the treatment of spontaneous bacterial peritonitis (SBP), cefotaxime, ceftriaxone, and ciprofloxacin were used as first-line agents. However, considering the increasing rate of antibiotic resistance, it is unclear which of these drugs can be initially recommended. This study aimed to compare the current efficacy of the 3 antibiotics, namely cefotaxime, ceftriaxone, and ciprofloxacin, for the treatment of SBP in patients with cirrhosis with ascites, when guided by therapeutic responses.
Methods: This study was a multicenter, prospective, randomized controlled trial. The inclusion criteria were 16- to 75-year-old patients with liver cirrhosis with ascites, having polymorphonuclear cell count of >250/mm 3 . We performed a follow-up paracentesis at 48 hours to decide continuing or changing the assigned antibiotics and then assessed the resolution rates at 120 and 168 hours of treatment.
Results: A total of 261 patients with cirrhosis who developed SBP were enrolled. Most of the patients were diagnosed as those with SBP within 48 hours of admission. The resolution rates at 120 hours, which is the primary endpoint, were 67.8%, 77.0%, and 73.6% in the cefotaxime, ceftriaxone, and ciprofloxacin groups, respectively ( P = 0.388), by intension-to-treat analysis. The 1-month mortality was similar among the groups ( P = 0.770). The model for end-stage liver disease score and the SBP resolution were significant factors for survival.
Conclusion: The efficacy of empirical antibiotics, such as cefotaxime, ceftriaxone, and ciprofloxacin, against SBP was not significantly different. In addition, these antibiotics administered based on response-guided therapy were still efficacious as initial treatment for SBP, especially in those with community-acquired infections.