Study of Trimethoprim/Sulfamethoxazole as PCP Prophylaxis in CTD Patients

Phase 2

• Conditions: Pneumonia, Pneumocystis; Prevention & Control
• Interventions: Drug: Trimethoprim/Sulfamethoxazole

• Registration Number: NCT01747278
• Lead Sponsor: Peking Union Medical College Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Status Verified: 2012-12
• Study First Submitted: 2012-12-09
• Study First Submitted QC: 2012-12-09
• Last Update Submitted: 2012-12-09
• Study First Posted: 2012-12-11
• Last Update Posted: 2012-12-11
• Primary Completion: 2013-06
• Study Completion: 2013-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TMP/SMX	Trimethoprim/Sulfamethoxazole	Patients received Trimethoprim/Sulfamethoxazole (TMP/SMX) 80 mg/400 mg p.o. every day as PCP Prophylaxis.

Primary Outcome Measures

Name	Time	Method
Documented PCP infection	12 weeks.	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.

Secondary Outcome Measures

Name	Time	Method
All cause mortality	12 weeks	All cause mortality at the end of week 12.
PCP-related hospitalization	12 weeks	PCP-related hospitalization throughout the study period.
PCP-related mortality	12 weeks	PCP-related mortality at the end of week 12.
Other infections	12 weeks	Infections other than PCP throughout the study period.

Trial Locations

Locations (1)

Deptment of Rheumatology, Peking Union Medical College Hospital; 🇨🇳 Beijing, China