Study of Trimethoprim/Sulfamethoxazole as PCP Prophylaxis in CTD Patients

Condition(s) targeted: Pneumonia, Pneumocystis; Prevention & Control

Intervention: Trimethoprim/Sulfamethoxazole (Drug)

Phase: Phase 2/Phase 3

Status: Recruiting

Sponsored by: Peking Union Medical College Hospital

Official(s) and/or principal investigator(s):
Fengchun Zhang, MD, Principal Investigator, Affiliation: Peking Union Medical College Hospital

Overall contact:
Hua Chen, MD, Phone: +86-10-69158797, Email: chenhua@pumch.cn

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.

Official title: The Safety and Effectiveness of Trimethoprim/Sulfamethoxazole as Pneumocystis Carinii Pneumonia (PCP) Prophylaxis in Patients With Connective Tissue Diseases

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Documented PCP infection

Secondary outcome:

PCP-related mortality

All cause mortality

Other infections

PCP-related hospitalization

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Hua Chen, MD, Phone: +86-10-69158797, Email: chenhua@pumch.cn

Deptment of Rheumatology, Peking Union Medical College Hospital, Beijing 100032, China; Recruiting
Fengchun Zhang, MD, Phone: +86-10-69158794, Email: ZhangFCcra@yahoo.com.cn
Fengchun Zhang, MD, Principal Investigator

Starting date: August 2012
Last updated: December 9, 2012