Clinical Trial: Study of Trimethoprim/Sulfamethoxazole as PCP Prophylaxis in CTD Patients
Study Status: Completed
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. ]
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