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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Oral Trimethoprim/Sulfamethoxazole 80 mg/400mg once daily for 12 weeks.
Deptment of Rheumatology, Peking Union Medical College Hospital
Beijing, China
RECRUITINGDocumented PCP infection
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.
Time frame: 12 weeks.
PCP-related mortality
PCP-related mortality at the end of week 12.
Time frame: 12 weeks
All cause mortality
All cause mortality at the end of week 12.
Time frame: 12 weeks
Other infections
Infections other than PCP throughout the study period.
Time frame: 12 weeks
PCP-related hospitalization
PCP-related hospitalization throughout the study period.
Time frame: 12 weeks
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