Study of Trimethoprim/Sulfamethoxazole as PCP Prophylaxis in CTD Patients

Prevention & Control Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01747278
• Other study ID #: PUMCH-CTD-PCP
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: December 9, 2012
• Last updated: December 9, 2012
• Start date: August 2012
• Est. completion date: August 2013

Study information

• Verified date: December 2012
• Source: Peking Union Medical College Hospital
• Contact: Hua Chen, MD
• Phone: +86-10-69158797
• Email: chenhua[@]pumch.cn
• Is FDA regulated: No
• Health authority: China: National Natural Science Foundation
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: August 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Connective Tissue Diseases
• Pneumonia
• Pneumonia, Pneumocystis
• Prevention & Control

Intervention

Drug:
• Trimethoprim/Sulfamethoxazole
Oral Trimethoprim/Sulfamethoxazole 80 mg/400mg once daily for 12 weeks.

Locations

Country	Name	City	State
China	Deptment of Rheumatology, Peking Union Medical College Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Documented 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.	12 weeks.	No
Secondary	PCP-related mortality	PCP-related mortality at the end of week 12.	12 weeks	No
Secondary	All cause mortality	All cause mortality at the end of week 12.	12 weeks	No
Secondary	Other infections	Infections other than PCP throughout the study period.	12 weeks	No
Secondary	PCP-related hospitalization	PCP-related hospitalization throughout the study period.	12 weeks	No