Clinical Trial: Study of Trimethoprim/Sulfamethoxazole as PCP Prophylaxis in CTD Patients

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: The Safety and Effectiveness of Trimethoprim/Sulfamethoxazole as Pneumocystis Carinii Pneumonia (PCP) Prophylaxis in Patients With Connective

Brief Summary:

Evaluation the efficacy and safety profile of trimethoprim/sulfamethoxazole as Pneumocystis carinii pneumonia (PCP) prophylaxis in Patients With Connective Tissue Diseases (CTD) treated with high-dose glucocorticoids and immunosuppressive agents.

Open-labeled, randomized, prospective single-center clinical trial. Observation period of 12 weeks.


Detailed Summary:
Sponsor: Peking Union Medical College Hospital

Current Primary Outcome: Documented PCP infection [ Time Frame: 12 weeks. ]

Documented Pneumocystis carinii pneumonia infection: defined as documentation of Pneumocystis from a properly obtained specimen (induced sputum, bronchoalveolar lavage, or biopsy) in a patient with clinical manifestations compatible with PCP.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • PCP-related mortality [ Time Frame: 12 weeks ]
    PCP-related mortality at the end of week 12.
  • All cause mortality [ Time Frame: 12 weeks ]
    All cause mortality at the end of week 12.
  • Other infections [ Time Frame: 12 weeks ]
    Infections other than PCP throughout the study period.
  • PCP-related hospitalization [ Time Frame: 12 weeks ]
    PCP-related hospitalization throughout the study period.


Original Secondary Outcome: Same as current

Information By: Peking Union Medical College Hospital

Dates:
Date Received: December 9, 2012
Date Started: August 2012
Date Completion: August 2013
Last Updated: December 9, 2012
Last Verified: December 2012