Interstitial Lung Diseases under systemic steroid therapy
Conditions
Interventions
This is a single-center, prospective, open-label, two-arm, parallel-group randomized controlled trial. Patients will be allocated by block randomization with predefined stratification factors. Two reg
D015662
Trimethoprim-sulfamethoxazole, TMP-SMX, Dose comparison, Low-dose regimen, Prophylaxis, PCP prophylaxis, Three-times-per-week nonconsecutive, Once-daily continuous
Sponsors
Tanaka Yusuke
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adults (>20y) with ILD receiving systemic glucocorticoids, written informed consent.
Exclusion criteria
Exclusion criteria: HIV infection; history of transplantation; current malignancy; pregnancy or lactation, or intention to become pregnant during the study period; severe renal impairment (eGFR or creatinine clearance <30 mL/min); prior Pneumocystis jirovecii pneumonia (PCP).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcomes: discontinuation due to adverse events and incidence of grade 3 or higher adverse events according to CTCAE version 5.0 at 1, 3, and 6 months and cumulatively through 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of PCP; time to discontinuation; incidence of individual AEs; subclinical PCP; all-cause mortality/hospitalization (optional). | — |
Contacts
Public ContactYusuke Tanaka
Sapporo Medical University
Outcome results
None listed