Anti-fungal treatment for peritoneal dialysis related fungal peritonitis
- Conditions
- Peritoneal dialysis-related fungal peritonitis
- Registration Number
- TCTR20210316001
- Lead Sponsor
- Ratchadapiseksompotch Fund
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- nknown
- Sex
- All
- Target Recruitment
- 80
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method All-cause mortality death death
- Secondary Outcome Measures
Name Time Method 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