Study of Trimethoprim/Sulfamethoxazole as PCP Prophylaxis in CTD Patients

• Status: Unknown status
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking Union Medical College Hospital
• Treatments: Sulfamethoxazole; Trimethoprim

Criteria

Inclusion Criteria:

• Age 18-65 years with informed consent

• SLE, Sjögren syndrome, Polymyositis or Dermatomyositis, defined by consensus classification criteria

• concomitant high dose glucocorticoid, defined as >1mg/kg/d prednisone or equivalent

• concomitant cyclophosphamide, cyclosporine or mycophenolate mofetil

Exclusion Criteria:

• Pregnant or lactating

• WBC< 4×10^9/L，PLT<100×10^9/L

• Serum ALT or AST > 2 times upper limit of normal

• Serum creatinine > 1.5 mg/dL

• Severe hepatic, hematological, gastrointestinal, pulmonary, cardiovascular, neurological, endocrine or cerebral disease

• Active infection, including HIV, HCV, HBV, tuberculosis or PCP

• concomitant antibiotics other than trimethoprim/sulfamethoxazole

• Patient with malignancy

• Drug allergy, especially trimethoprim/sulfamethoxazole