Voriconazole-based Regimen for peritoneal dialysis-related Fungal Peritonitis

Phase 3

• Conditions: Peritoneal dialysis-related fungal peritonitis; peritoneal dialysis; peritonitis; fungi

• Registration Number: TCTR20230316005
• Lead Sponsor: Chulalongkorn university

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-16
• Last Update Posted: 19 August 2024
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 115

Inclusion Criteria

1. Patients undergoing maintenance peritoneal dialysis
2. Patients must have active peritoneal dialysis-related peritonitis according to the ISPD criteria
3. Diagnosis of fungal peritonitis confirmed by one 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. The morphology of the 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 followings: 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
5. Patients with decompensated liver disease including acute liver failure and decompensated cirrhosis (Child B, C)
6. Patients with QTc >0.500 seconds or QTc >0.45 seconds with evidence of underlying cardiomyopathy
7. Pregnant or lactating women
8. Patients with terminal illnesses including end-stage cardiopulmonary disease or advance stage cancer who are expected to live less than 1 year
9. 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
mortality rate at 12 months after completion of treatment proportion of patients who have died out of total enrolled patients

Secondary Outcome Measures

Name	Time	Method
Mortality rate by pathogen group at 12 months after completion of treatment Proportion of patients who have died out of total enrolled patients,Complete response rate at 4 weeks after treatment initiation Proportion of patients who show complete clinical improvement at the end of 4-week antifungal treatment,Pharmacokinetic of voriconazole day 5 after treatment initiation Drug availability of voriconazole by measuring plasma level and calculate area under the curve (AUC) in a subset of patients