Study of Trimethoprim/Sulfamethoxazole as PCP Prophylaxis in CTD Patients

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase

Unknown

Phase 3

Phase 2

Conditions

Prevention & Control

Pneumonia, Pneumocystis

Treatments

Drug: Trimethoprim/Sulfamethoxazole

Study type

Interventional

Funder types

Other

Identifiers

NCT01747278

PUMCH-CTD-PCP

Details and patient eligibility

About

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.

Enrollment

80 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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