Study of Trimethoprim/Sulfamethoxazole as PCP Prophylaxis in CTD Patients
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.
Prevention & Control
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Safety and Effectiveness of Trimethoprim/Sulfamethoxazole as Pneumocystis Carinii Pneumonia (PCP) Prophylaxis in Patients With Connective Tissue Diseases|
- Documented PCP infection [ Time Frame: 12 weeks. ] [ Designated as safety issue: No ]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.
- PCP-related mortality [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]PCP-related mortality at the end of week 12.
- All cause mortality [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]All cause mortality at the end of week 12.
- Other infections [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Infections other than PCP throughout the study period.
- PCP-related hospitalization [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]PCP-related hospitalization throughout the study period.
|Study Start Date:||August 2012|
|Estimated Study Completion Date:||August 2013|
|Estimated Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
No Intervention: Placebo
Patients were not treated with Trimethoprim/Sulfamethoxazole (TMP/SMX).
Patients received Trimethoprim/Sulfamethoxazole (TMP/SMX) 80 mg/400 mg p.o. every day as PCP Prophylaxis.
Oral Trimethoprim/Sulfamethoxazole 80 mg/400mg once daily for 12 weeks.
Other Name: Septra
Please refer to this study by its ClinicalTrials.gov identifier: NCT01747278
|Contact: Hua Chen, MDfirstname.lastname@example.org|
|Deptment of Rheumatology, Peking Union Medical College Hospital||Recruiting|
|Beijing, China, 100032|
|Contact: Fengchun Zhang, MD +86-10-69158794 ZhangFCcra@yahoo.com.cn|
|Principal Investigator: Fengchun Zhang, MD|
|Principal Investigator:||Fengchun Zhang, MD||Peking Union Medical College Hospital|