Study of Trimethoprim/Sulfamethoxazole as PCP Prophylaxis in CTD Patients

This study is currently recruiting participants.
Verified December 2012 by Peking Union Medical College Hospital
Sponsor:
Information provided by (Responsible Party):
Fengchun Zhang, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:
NCT01747278
First received: December 9, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Pneumonia, Pneumocystis
Prevention & Control
Drug: Trimethoprim/Sulfamethoxazole
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Safety and Effectiveness of Trimethoprim/Sulfamethoxazole as Pneumocystis Carinii Pneumonia (PCP) Prophylaxis in Patients With Connective Tissue Diseases

Resource links provided by NLM:


Further study details as provided by Peking Union Medical College Hospital:

Primary Outcome Measures:
  • Documented PCP infection [ Time Frame: 12 weeks. ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • PCP-related mortality [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    PCP-related mortality at the end of week 12.

  • All cause mortality [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    All cause mortality at the end of week 12.

  • Other infections [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Infections other than PCP throughout the study period.

  • PCP-related hospitalization [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    PCP-related hospitalization throughout the study period.


Estimated Enrollment: 80
Study Start Date: August 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Trimethoprim/Sulfamethoxazole
Oral Trimethoprim/Sulfamethoxazole 80 mg/400mg once daily for 12 weeks.
Other Name: Septra

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01747278

Contacts
Contact: Hua Chen, MD +86-10-69158797 chenhua@pumch.cn

Locations
China
Deptment of Rheumatology, Peking Union Medical College Hospital Recruiting
Beijing, China, 100032
Contact: Fengchun Zhang, MD    +86-10-69158794    ZhangFCcra@yahoo.com.cn   
Principal Investigator: Fengchun Zhang, MD         
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
Principal Investigator: Fengchun Zhang, MD Peking Union Medical College Hospital
  More Information

No publications provided

Responsible Party: Fengchun Zhang, Professor, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT01747278     History of Changes
Other Study ID Numbers: PUMCH-CTD-PCP
Study First Received: December 9, 2012
Last Updated: December 9, 2012
Health Authority: China: National Natural Science Foundation

Keywords provided by Peking Union Medical College Hospital:
Pneumocystis carinii pneumonia
prophylaxis
trimethoprim/sulfamethoxazole

Additional relevant MeSH terms:
Connective Tissue Diseases
Pneumonia
Pneumonia, Pneumocystis
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Lung Diseases, Fungal
Mycoses
Pneumocystis Infections
Sulfamethoxazole
Trimethoprim
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Infective Agents, Urinary
Renal Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 16, 2014