Acta Medica Okayama 73巻 1号
2019-02 発行

Conventional-dose Versus Half-dose Sulfamethoxazole-trimethoprim for the Prophylaxis of Pneumocystis Pneumonia in Patients with Systemic Rheumatic Disease: A Non-blind, Randomized Controlled Trial

Abe, Yoshiyuki Department of Internal Medicine and Rheumatology, Juntendo University School of Medicine
Fujibayashi, Kazutoshi Medical Technology Innovation Center, Juntendo University
Nishizaki, Yuji Medical Technology Innovation Center, Juntendo University
Yanagisawa, Naotake Medical Technology Innovation Center, Juntendo University
Nojiri, Shuko Clinical Research and Trial Center, Juntendo University Hospital
Nakano, Soichiro Geriatric General Medicine, Juntendo Tokyo Koto Geriatric Medical Center
Tada, Kurisu Department of Internal Medicine and Rheumatology, Juntendo University School of Medicine
Yamaji, Ken Department of Internal Medicine and Rheumatology, Juntendo University School of Medicine
Tamura, Naoto Department of Internal Medicine and Rheumatology, Juntendo University School of Medicine
Publication Date
2019-02
Abstract
Pneumocystis pneumonia (PCP) due to Pneumocystis jirovecii infection is the leading cause of fatal opportunistic infections in immunocompromised patients. We will determine whether a daily sulfamethoxazole-trimethoprim (SMX/TMP) dose of 200/40 mg was non-inferior to 400/80 mg for PCP prevention in patients with systemic rheumatic disease under immunosuppressive therapy. This is a randomized, open-label, multicenter controlled trial. The primary outcome is the rate of PCP prevention at 52 weeks. The secondary outcome is the discontinuation rate of SMX/TMP. The trial will evaluate the optimal dose of SMX/TMP for PCP prevention in patients with systemic rheumatic disease under immunosuppressive therapy.
Document Type
Clinical Study Protocol
Keywords
pneumocystis pneumonia
prophylaxis
systemic rheumatic disease
sulfamethoxazole-trimethoprim
conventional-dose versus half-dose
Thumnail 73_1_85.pdf 2.6 MB