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
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2012
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
December 9, 2012
CompletedFirst Posted
Study publicly available on registry
December 11, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedDecember 11, 2012
December 1, 2012
10 months
December 9, 2012
December 9, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Secondary Outcomes (4)
PCP-related mortality
12 weeks
All cause mortality
12 weeks
Other infections
12 weeks
PCP-related hospitalization
12 weeks
Study Arms (2)
Placebo
NO INTERVENTIONPatients were not treated with Trimethoprim/Sulfamethoxazole (TMP/SMX).
TMP/SMX
EXPERIMENTALPatients received Trimethoprim/Sulfamethoxazole (TMP/SMX) 80 mg/400 mg p.o. every day as PCP Prophylaxis.
Interventions
Oral Trimethoprim/Sulfamethoxazole 80 mg/400mg once daily for 12 weeks.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Deptment of Rheumatology, Peking Union Medical College Hospital
Beijing, 100032, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fengchun Zhang, MD
Peking Union Medical College Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 9, 2012
First Posted
December 11, 2012
Study Start
August 1, 2012
Primary Completion
June 1, 2013
Study Completion
August 1, 2013
Last Updated
December 11, 2012
Record last verified: 2012-12