Study of Trimethoprim/Sulfamethoxazole as PCP Prophylaxis in CTD Patients
NCT ID: NCT01747278
Last Updated: 2012-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
80 participants
INTERVENTIONAL
2012-08-31
2013-08-31
Brief Summary
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Open-labeled, randomized, prospective single-center clinical trial. Observation period of 12 weeks.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Placebo
Patients were not treated with Trimethoprim/Sulfamethoxazole (TMP/SMX).
No interventions assigned to this group
TMP/SMX
Patients received Trimethoprim/Sulfamethoxazole (TMP/SMX) 80 mg/400 mg p.o. every day as PCP Prophylaxis.
Trimethoprim/Sulfamethoxazole
Oral Trimethoprim/Sulfamethoxazole 80 mg/400mg once daily for 12 weeks.
Interventions
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Trimethoprim/Sulfamethoxazole
Oral Trimethoprim/Sulfamethoxazole 80 mg/400mg once daily for 12 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Peking Union Medical College Hospital
OTHER
Responsible Party
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Fengchun Zhang
Professor
Principal Investigators
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Fengchun Zhang, MD
Role: PRINCIPAL_INVESTIGATOR
Peking Union Medical College Hospital
Locations
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Deptment of Rheumatology, Peking Union Medical College Hospital
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Fengchun Zhang, MD
Role: primary
Other Identifiers
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PUMCH-CTD-PCP
Identifier Type: -
Identifier Source: org_study_id