Study of Trimethoprim/Sulfamethoxazole as PCP Prophylaxis in CTD Patients

Study Overview
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Brief Summary
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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.

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

Conditions
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Pneumonia, Pneumocystis, Prevention & Control

Intervention / Treatment
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* Drug: Trimethoprim/Sulfamethoxazole


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Placebo<br>Patients were not treated with Trimethoprim/Sulfamethoxazole (TMP/SMX). | |
| Experimental: TMP/SMX<br>Patients received Trimethoprim/Sulfamethoxazole (TMP/SMX) 80 mg/400 mg p.o. every day as PCP Prophylaxis. | Drug: Trimethoprim/Sulfamethoxazole<br>* Oral Trimethoprim/Sulfamethoxazole 80 mg/400mg once daily for 12 weeks.<br>* Other names: Septra;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PCP-related mortality | PCP-related mortality at the end of week 12. | 12 weeks | 
| All cause mortality | All cause mortality at the end of week 12. | 12 weeks | 
| Other infections | Infections other than PCP throughout the study period. | 12 weeks | 
| PCP-related hospitalization | PCP-related hospitalization throughout the study period. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pneumocystis carinii pneumonia, prophylaxis, trimethoprim/sulfamethoxazole