Real-World Practices of Fluoroquinolone Prophylaxis in Spontaneous Bacterial Peritonitis: A Longitudinal Study from a Tertiary Care Center in North India

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Abstract

Background and objectives

Spontaneous bacterial peritonitis (SBP) is a life-threatening complication of cirrhosis with ascites, carrying one- and two-year mortality rates exceeding 70% and 80%, respectively. Fluoroquinolone prophylaxis is the cornerstone of SBP prevention. Real- world longitudinal data on prescribing practices and clinical outcomes from Indian tertiary care centers are sparse. We aimed to evaluate fluoroquinolone prescribing patterns, guideline adherence, and six-month clinical outcomes in SBP patients at a tertiary academic center in North India.

Methods

This was a pre-specified sub-analysis of a 15-month analytical longitudinal study at AIIMS Rishikesh. Adults (age ≥18 years) admitted with SBP and initiated on fluoroquinolone prophylaxis were enrolled consecutively and followed for six months. Prescribing practices were compared against EASL and AASLD recommendations. The primary outcome was the rate of guideline-directed prescribing. Secondary outcomes included clinical cure at discharge, six- month cure, relapse, regimen modification, adverse drug reactions, and treatment compliance. Categorical variables were compared by Fisher’s exact test or chi-squared test (SPSS).

Results

Forty-eight SBP patients were included (mean age 44.75 ± 11.94 years; 85.4% male). Guideline-directed fluoroquinolone prophylaxis was prescribed to all patients (100%). Norfloxacin 400 mg once daily was predominant (85.4%), followed by levofloxacin (10.4%) and moxifloxacin (4.2%). Cure at discharge was 85.4%. At six months, 64.6% maintained sustained cure and 22.9% relapsed. Regimen modification occurred in 22.9%, most commonly antimicrobial substitution. Nausea was the only adverse drug reaction (4.8%). Treatment compliance was 73.8%. No patient underwent therapeutic drug monitoring.

Conclusions

Fluoroquinolone prescribing for SBP prophylaxis at AIIMS Rishikesh was fully concordant with standard guidelines. Despite complete adherence, a relapse rate of 22.9% and frequent regimen modification underscore the limitations of long-term fluoroquinolone prophylaxis, likely reflecting emerging quinolone resistance. Strengthening antimicrobial stewardship is essential to sustain prophylaxis effectiveness in Indian tertiary care settings.

Trial registration

CTRI/2025/06/088655

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