A combination therapy of surgery, antibacterial agents and antifungal agents for human pythiosis
Phase 1
- Conditions
- Patients with vascular pythiosispythiosisP.insidiosumazithromycinitraconazoledoxycycline
- Registration Number
- TCTR20191217006
- Lead Sponsor
- ็Health Systems Research Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Unknown
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
1.Patient age of 18 years or above
2.Patient is diagnosed with human pythiosis based on clinical presentation and additional 2 out of 4 criteria below;
-Patient has positive serum P. insidiosum antibody based on in-house enzyme-linked immunosorbent assay (ELISA)
-Positive cultures for P. insidiosum, confirmed by zoospore induction and nucleic acid sequencing, from tissue samples
-Consistent pathological finding with broad-sized hyaline septate hyphae in tissues
-Detection P. insidiosum DNA by polymerase chain reaction (PCR) in tissue samples
Exclusion Criteria
1.Patient has other concurrent fungal infection
2.Patient is not willing to follow up according to the study protocol
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To study mortality in vascular pythiosis after using antibacterial agents as a part of treatment reg 6 months and 1 year after diagnosis Descriptive statistics
- Secondary Outcome Measures
Name Time Method To study in vitro susceptibility of antibacterial and antifungal agents against P.insidiosum isolate N/A N/A,To study correlation between ESR, CRP and serum (1,3) beta-d-glucan and P.insidiosum antibody N/A Spearman's correlation coefficient and longitudinal regression,To study itraconazole level in correlation with itraconazole MIC and clinical outcomes N/A Descriptive statistics