ArticleAntibiotics (Basel, Switzerland)2025
Simplifying Antibiotic Management of Peritonitis in APD: Evidence from a Non-Inferiority Randomized Trial.
Article in Antibiotics (Basel, Switzerland), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04077996 (Randomized Multicentric Clinical Trial, Efficcacy of the Treatment Application on Peritonitis in Automated Peritoneal Dialysis), which is not on this map. Not yet cited in PubMed.
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The trial behind it
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Randomized Multicentric Clinical Trial, Efficcacy of the Treatment Application on Peritonitis in Automated Peritoneal Dialysis (APD); Comparision Between APD Versus Ambulatory Dialysis.
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14 authors.
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No grant is acknowledged in the PubMed record.
Abstract
INTRODUCTION/
objectivePeritonitis remains a serious complication in patients undergoing automated peritoneal dialysis (APD), requiring prompt and effective antibiotic administration. This study evaluated whether delivering antibiotics directly through APD bags is as effective as administering them via an additional manual daytime exchange.
methodsWe conducted a randomized, single-blind, non-inferiority clinical trial involving patients diagnosed with peritonitis. Participants were randomly assigned to receive Ceftazidime and Vancomycin, either via APD bags or through a combined approach of continuous ambulatory peritoneal dialysis (CAPD) plus APD. A total of 64 patients (32 per group) were enrolled, with comparable baseline demographic and clinical profiles, including laboratory markers of infection severity and dialysis history.
resultsPeritonitis resolved in 90.6% of the patients treated via APD bags and in 81.3% of those receiving antibiotics through manual exchange plus APD. Although this difference did not reach statistical significance (p = 0.281), the observed absolute difference of 9.3% was well within the predefined non-inferiority margin of 30%, supporting the clinical non-inferiority of the APD-only method. The mean time to resolution was similar between groups (p = 0.593). Post hoc power analyses indicated limited statistical power (18.5% for the resolution rate and 9.2% for time to resolution), suggesting that modest differences may not have been detectable given the sample size. Nevertheless, the high resolution rates observed in both groups reflect valid and encouraging clinical outcomes.
conclusionAntibiotic administration via APD bags demonstrated comparable clinical effectiveness to the combined manual exchange plus APD method for treating peritonitis. Given its operational simplicity and favorable results, the APD-only strategy may offer a pragmatic alternative in routine care. Further studies with larger sample sizes are recommended to confirm these findings and optimize treatment protocols.
trial registrationNCT04077996. FUNDING SOURCE: None to declare.
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