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

Acta Med Okayama. 2019 Feb;73(1):85-89. doi: 10.18926/AMO/56464.

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.

Keywords: conventional-dose versus half-dose; pneumocystis pneumonia; prophylaxis; sulfamethoxazole-trimethoprim; systemic rheumatic disease.

Publication types

  • Clinical Trial Protocol

MeSH terms

  • Adult
  • Anti-Bacterial Agents / administration & dosage
  • Anti-Bacterial Agents / therapeutic use*
  • Dose-Response Relationship, Drug
  • Female
  • Humans
  • Male
  • Multicenter Studies as Topic
  • Pneumonia, Pneumocystis / prevention & control*
  • Randomized Controlled Trials as Topic*
  • Trimethoprim, Sulfamethoxazole Drug Combination / administration & dosage
  • Trimethoprim, Sulfamethoxazole Drug Combination / therapeutic use*

Substances

  • Anti-Bacterial Agents
  • Trimethoprim, Sulfamethoxazole Drug Combination