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Study of Trimethoprim/Sulfamethoxazole as PCP Prophylaxis in CTD Patients | Clinical Trials | Clareo Health

UNKNOWNPHASE2/PHASE3

Study of Trimethoprim/Sulfamethoxazole as PCP Prophylaxis in CTD Patients

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

NCT01747278•Peking Union Medical College Hospital

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 65 years

Sex

ALL

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

Locations (1)

Deptment of Rheumatology, Peking Union Medical College Hospital

Beijing, China

Key Dates

Start Date

August 1, 2012

Primary Completion Date

June 1, 2013

Completion Date

August 1, 2013

Last Updated

December 11, 2012

Enrollment

ESTIMATED participants

Conditions

Pneumonia, PneumocystisPrevention & Control

Interventions

Trimethoprim/Sulfamethoxazole

DRUG

Contacts

Hua Chen, MD

CONTACT

+86-10-69158797 chenhua@pumch.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 11, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study of Trimethoprim/Sulfamethoxazole as PCP Prophylaxis in CTD Patients

Inclusion Criteria

Exclusion Criteria

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