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. peritoneal dialysis, 4-week voriconazole, fungal peritonitis
Conditions
Interventions
Use a single-arm study to evaluate the efficacy of the protocol-based 4-week empirical oral voriconazole treatment for 1-year patient survival on peritoneal dialysis (PD) patients with PD-related fung
Experimental Drug
4-week empirical oral voriconazole treatment
Sponsors
Faculty of Medicine, Chulalongkorn University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Thailand
Contacts
Public ContactTalerngsak Kanjanabuch
Faculty of Medicine, Chulalongkorn University
Outcome results
None listed