Abstract: FR-PO506
Efficacy of Empirical Voriconazole vs. Amphotericin B Plus Flucytosine in Peritoneal Dialysis Patients With Fungal Peritonitis (VAF Study): Early Results From a Randomized Controlled Trial
Session Information
- Peritoneal Dialysis: Current Topics
November 04, 2022 | Location: Exhibit Hall, Orange County Convention Center‚ West Building
Abstract Time: 10:00 AM - 12:00 PM
Category: Dialysis
- 702 Dialysis: Home Dialysis and Peritoneal Dialysis
Authors
- Puapatanakul, Pongpratch, Chulalongkorn University, Bangkok, Bangkok, Thailand
- Tungsanga, Somkanya, Chulalongkorn University, Bangkok, Bangkok, Thailand
- Kanjanabuch, Talerngsak, Chulalongkorn University, Bangkok, Bangkok, Thailand
Group or Team Name
- VAF study steering committee
Background
Fungal peritonitis is a rare but life-threatening complication in patients undergoing peritoneal dialysis (PD). we studied the efficacy of two different empirical antifungal regimens for the treatment of PD-related fungal peritonitis.
Methods
In a multicenter open-label randomized controlled trial (TCTR20210316001), PD patients aged ≥18 presenting with fungal peritonitis from 18 centers in Thailand were randomized to receive an empirical antifungal regimen of either oral voriconazole (Vz) 6 mg/kg twice daily on day 1 followed by 4 mg/kg twice daily or intravenous amphotericin B (AmB) 1 mg/kg/day plus oral flucytosine (Fluc) 500 mg twice daily, stratified by fungal types (yeast or mold). The PD catheter was removed as soon as possible, and antifungal drugs were continued for at least 14 days after catheter removal and stopped if clinical response was evident. Change in the antifungal drug was allowed upon knowledge of pathogen species but not earlier than 7 days. The primary outcome was mortality at 90 days.
Results
82 PD patients with fungal peritonitis were enrolled (32 [40%] yeast and 48 [60%] mold ) of which 39 and 41 patients received empirical treatment with Vz or AmB plus Fluc, respectively. Empirical drugs resulted in clinical response at 14 days after PD catheter removal, and treatments could be stopped in 87% in Vz group and 83% in AmB plus Fluc group (p=0.59). There was a trend toward a higher mortality rate at 90 days in AmB plus Fluc group compared with Vz group but did not reach statistical significance (Vz 5% vs. AmB plus Fluc 20%, p=0.052). The proportion of patients in whom physicians attempted to resume PD (Vz 28% vs. AmB plus Fluc 29%, p=0.92) and success rate of resuming PD (Vz 82% vs. AmB plus Fluc 83%, p=0.92) were not significantly different between treatment groups. Reversible elevation of serum alkaline phosphatase was documented in 5% of patients in Vz group.
Conclusion
Both empirical antifungal treatment regimens are feasible and well tolerated by PD patients. A trend of superior 90-day survival for treatment with Vz could be attributable to a high incidence of mold peritonitis in this study.
Funding
- Commercial Support – Siam Pharmaceutical Co., Ltd. provided study drugs (voriconazole, flucytosine)