Connective tissue diseases, Rheumatic diseases
Conditions
Interventions
Trimethoprim-sulfamethoxazole (TMP/SMX) will be administered prophylactically at a lower dose than the standard prophylactic regimen for Pneumocystis pneumonia, specifically 40 mg TMP / 200 mg SMX thr
Sponsors
Sendo Sho
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who meet all of the following criteria will be eligible for participation: (1) Patients who are hospitalized in the Department of Rheumatology and Clinical Immunology, Kobe University Hospital at the initiation of the study. (2) Patients aged 18 years or older at the time of obtaining consent (regardless of gender). (3) Patients who are scheduled to start immunosuppressive therapy (prednisolone equal to or greater than 20 mg/day with or without other immunosuppressive agents), or who are within 14 days after initiating such therapy. (4) Patients who are expected to receive immunosuppressive therapy (prednisolone equal to or greater than 20 mg/day with or without other immunosuppressive agents) for at least 4 weeks. (5) Patients who are able to start trimethoprim-sulfamethoxazole (TMP-SMX) within 14 days after the initiation of immunosuppressive therapy. (6) Patients who have provided written informed consent of their own free will to participate in this clinical study.
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria will be excluded from the study: (1) Patients with a history of hypersensitivity to any component of the study drug or to sulfonamides. (2) Patients who are already receiving prophylaxis for Pneumocystis pneumonia (e.g., atovaquone). (3) Pregnant or breastfeeding women. (4) Patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency. (5) Patients deemed inappropriate for this intervention by the principal investigator or sub-investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Continuation of TMP-SMX prophylaxis without the development of Pneumocystis pneumonia (PCP) or related complications through Week 52 | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy Outcomes: Incidence of Pneumocystis pneumonia (PCP) by Weeks 12, 24, and 52, respectively Continuation of TMP-SMX at Weeks 12, 24, and 52, respectively Incidence of non-PCP infections (e.g., urinary tract infections, respiratory tract infections) Time to discontinuation of TMP-SMX due to PCP or complications (to be assessed at each time point) Safety Outcomes: Cytopenia (including leukopenia, anemia/hemoglobin reduction, and thrombocytopenia) Hepatotoxicity (defined as AST or ALT levels equal to or greater than the baseline) Drug-induced skin rash attributed to TMP-SMX Electrolyte abnormalities Any other adverse events | — |
Contacts
Public ContactSho Sendo
Kobe University Hospital
Outcome results
None listed