An Efficacy of The Protocol-based Empirical Treatment With 4-week Oral Voriconazole for Peritoneal Dialysis-related Fungal Peritonitis

Phase 3

• Conditions: peritoneal dialysis, 4-week voriconazole, fungal peritonitis; Patients who greater than or equal to 18 years old undergoing PD, must have active PD-related peritonitis according to ISPD criteria, Identification of fungi by microscopic study of PD effluent or any PD-related specimens including particles in the removed PD catheter and positive culture for fungi in the PD effluent or PD-related specimens.

• Registration Number: TCTR20240402002
• Lead Sponsor: Faculty of Medicine, Chulalongkorn University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-02
• Last Update Posted: 19 August 2024
• Study Completion: 2026-05-31

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Patients >18 years old undergoing PD
2. Patients must have active PD-related peritonitis according to ISPD criteria
3. Diagnosis of fungal peritonitis confirmed by any of the following
3.1 Identification of fungi by microscopic study of PD effluent or any PD-related specimens including particles in the removed PD catheter
3.2 A positive culture for fungi in the PD effluent or PD-related specimens

Exclusion Criteria

1. Causative fungus is non-septated hyphae suspected to be Zygomycetes.
2. Patients with severe sepsis or septic shock defined by fulfilling criteria for systemic inflammatory response syndrome (SIRS) together with organ failure or shock
3. Patients suspected to have secondary peritonitis by the presence of any of the following: localized abdominal tenderness, fecal or bile contents in the PD effluent, multiple bacterial and/or fungal organisms identified in the PD effluent, or radiologic evidence of intrabdominal diseases such as intestinal obstruction or perforation
4. Patients with co-infection by other non-fungal pathogens identified in the same clinical specimens that isolate the fungus
- Patients with decompensated liver disease including acute liver failure and decompensated cirrhosis (Child B, C)
5. Patients with QTc >0.500 seconds or QTc >0.45 seconds with evidence of underlying cardiomyopathy
6. Pregnant or lactating women
7. Patients with terminal illnesses including end-stage cardiopulmonary disease or advance stage cancer who are expected to live less than 1 year
8. Patients with a history of hypersensitivity (any degree) to azole drugs

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1-year survival rate within one year after end of the intervention Evaluate the 1-year survival rate of PD patients with PD-related fungal peritonitis receiving antifungal therapy with a 4-week empirical oral voriconazole-based protocol

Secondary Outcome Measures

Name	Time	Method
Survival rates in patient groups by pathogen types within one year after end of the intervention Describe patient survival rates in patient groups by pathogen types (mold or yeast),Response rates within one week after end of the intervention Evaluate the complete response rates to the treatment protocol in overall patients and patient groups by pathogen types (mold or yeast)