Tokyo, March 12 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060898) titled 'Prospective study evaluating the efficacy and safety of low-dose trimethoprim-sulfamethoxazole for prevention of Pneumocystis pneumonia in patients with interstitial lung disease' on March 11.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - Sapporo Medical University

Condition: Condition - Interstitial Lung Disease Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The objective of this study is to evaluate the efficacy and safety of low-dose sulfamethoxazole-trimethoprim prophylaxis for the prevention of Pneumocystis pneumonia (PCP) in patients with interstitial lung disease. This prospective randomized trial aims to determine whether low-dose ST prophylaxis is non-inferior to the conventional prophylactic regimen in preventing PCP. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - In the standard-dose group, one tablet of sulfamethoxazole-trimethoprim (sulfamethoxazole 400 mg / trimethoprim 80 mg) is administered orally once daily. Treatment is continued during corticosteroid therapy for up to 48 weeks. Interventions/Control_2 - In the intervention group, one tablet of sulfamethoxazole-trimethoprim (400 mg/80 mg) is administered three times per week (e.g., Monday, Wednesday, and Friday). Treatment is continued during corticosteroid therapy for up to 48 weeks.

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Patients aged 20 years or older with interstitial lung disease receiving corticosteroid therapy. Key exclusion criteria - Patients with HIV infection, a history of organ transplantation, or those who are pregnant or breastfeeding, as well as patients planning pregnancy during the study period. Patients with severe renal impairment (eGFR < 30 mL/min/1.73 m2) will be assigned to the renal impairment group. Target Size - 120

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2025 Year 06 Month 12 Day Date of IRB - 2025 Year 06 Month 12 Day Anticipated trial start date - 2025 Year 07 Month 01 Day Last follow-up date - 2030 Year 04 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069690

Disclaimer: Curated by HT Syndication.