Peritoneal dialysis-related fungal peritonitis peritoneal dialysis peritonitis fungi
Conditions
Interventions
All patients will be treated by an oral voriconazole-based empirical treatment protocol as follows:
1. A PD catheter is surgically removed as soon as possible (within 3 days).
2. Enrolled patients rec
empirical phase).
3. Voriconazole is continued until 28 days (D8-28
definitive phase) unless a specific causative fungal pathogen can be identified and show intrinsic superior susceptibility to other antifungal drugs, in which case the antifungal drug will be changed
Active Comparator Drug
Empirical oral voriconazole
Sponsors
Chulalongkorn university
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| mortality rate at 12 months after completion of treatment proportion of patients who have died out of total enrolled patients | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Thailand
Contacts
Public ContactPongpratch Puapatanakul
Faculty of Medicine, Chulalongkorn University
Outcome results
None listed