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Randomized Controlled Trial
. 2023 Apr 1;118(4):654-663.
doi: 10.14309/ajg.0000000000002126. Epub 2023 Jan 3.

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

Hyung Joon Yim  1 , Tae Hyung Kim  1 , Sang Jun Suh  1 , Sun Young Yim  1 , Young Kul Jung  1 , Yeon Seok Seo  1 , Seong Hee Kang  1   2   3 , Moon Young Kim  2 , Soon Koo Baik  2 , Hong Soo Kim  4 , Young Seok Kim  4 , Soo Young Park  5 , Byung Ik Kim  6 , Jun Yong Park  7 , Jeong Heo  8 , Joo Hyun Sohn  9 , Nae-Yun Heo  10 , Kwang-Hyub Han  7 , Soon Ho Um  1
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Randomized Controlled Trial

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

Hyung Joon Yim et al. Am J Gastroenterol. .

Abstract

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.

Trial registration: ClinicalTrials.gov NCT01265173.

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References

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