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A Phase II Multicenter, Open-Label Study of Surgery and Combination Therapy with Azithromycin, Doxycycline, and Itraconazole for the Treatment of Vascular Pythiosis

A Phase II Multicenter, Open-Label Study of Surgery and Combination Therapy with Azithromycin, Doxycycline, and Itraconazole for the Treatment of Vascular Pythiosis

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20191217006
Enrollment
50
Registered
2019-12-17
Start date
2020-01-14
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with vascular pythiosis pythiosis P.insidiosum azithromycin itraconazole doxycycline

Interventions

All patients need radical surgery to remove all infected tissues if feasible in conjunction with itraconazole 200 mg q 8 h&#44
azithromycin 500 mg daily and doxycycline 100 mg q 12 h
Experimental Drug
Surgery with antimicrobial agents

Sponsors

Health Systems Research Institute
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

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

Exclusion criteria: 1. Patient has other concurrent fungal infection 2. Patient is not willing to follow up according to the study protocol

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Thailand

Contacts

Public ContactNitipong Permpalung

Faculty of Medicine, Chulalongkorn University; Johns Hopkins University School of Medicine

npermpa1@jhmi.edu16074352036

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026