Peritoneal dialysis-related fungal peritonitis Peritoneal dialysis-related fungal peritonitis
Conditions
Interventions
Voriconazole loading 6 mg/kg orally BID on day 1,
then 4 mg/kg orally BID on day 2-14,Amphotericine B 1 mg/kg/day intravenously
plus
Flucytosine (500 mg) 1 tab BID orally
both for at least 14 days af
Active Comparator Drug,Active Comparator Drug
Voriconazole,Amphotericin plus flucytosine
Sponsors
Ratchadapiseksompotch Fund
Siam Pharmaceutical
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Written informed consent obtained 2. Patients >18 years old undergoing PD 3. Diagnosis of fungal peritonitis confirmed by any of the following a. Identification of fungi by microscopic study of PD effluent or any PD-related specimens including particles in the removed PD catheter b. Positive culture for fungi in the PD effluent or PD-related specimens
Exclusion criteria
Exclusion criteria: 1. The morphology of 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 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 who have received any forms of anti-fungal drugs more than 3 days prior to enrolment except for nystatin or fluconazole at a prophylaxis dose 5. Patients with co-infection by other non-fungal pathogens identified in the same clinical specimens that isolate the fungus 6. Patients with decompensated liver disease including acute liver failure and decompensated cirrhosis 7. Patients with QTc prolongation (>0.45 second) 8. Pregnant or lactating women 9. Patients with terminal illness including end-stage cardiopulmonary disease or advance stage cancer who are expected to live less than 1 year 10. Patients with history of hypersensitivity (any degree) to amphotericin B or any drugs in the azole group
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All-cause mortality death death | — |
Secondary
| Measure | Time frame |
|---|---|
| All-cause mortality 24 weeks after the end of intervention Death,All-cause mortality 48 weeks after the end of intervention Death,Rate of complete adherence to the study protocol During study treatment protocol deviation,Response rate 14 days after PD catheter removal resolution of fever for 7 days with overall improvement in symptoms,Rate of peritonitis-related complication 12 weeks relapse/recurrent peritonitis, subsequent abdominal infection,Rate of successful return to PD 12 weeks Reinsertion of PD catheter and successful start of PD at home | — |
Countries
Thailand
Contacts
Public ContactPongpratch Puapatanakul
Division of Nephrology, Department of Medicine, Faculty of Medicine, Chulalongkorn University
Outcome results
None listed