Study of Trimethoprim/Sulfamethoxazole as PCP Prophylaxis in CTD Patients

Overview

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.

Full Title of Study: “The Safety and Effectiveness of Trimethoprim/Sulfamethoxazole as Pneumocystis Carinii Pneumonia (PCP) Prophylaxis in Patients With Connective Tissue Diseases”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2013

Interventions

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

Arms, Groups and Cohorts

  • No Intervention: Placebo
    • Patients were not treated with Trimethoprim/Sulfamethoxazole (TMP/SMX).
  • Experimental: TMP/SMX
    • Patients received Trimethoprim/Sulfamethoxazole (TMP/SMX) 80 mg/400 mg p.o. every day as PCP Prophylaxis.

Clinical Trial Outcome Measures

Primary Measures

  • Documented PCP infection
    • Time Frame: 12 weeks.
    • 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.

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Peking Union Medical College Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Fengchun Zhang, Professor – Peking Union Medical College Hospital
  • Overall Official(s)
    • Fengchun Zhang, MD, Principal Investigator, Peking Union Medical College Hospital
  • Overall Contact(s)
    • Hua Chen, MD, +86-10-69158797, chenhua@pumch.cn

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