Study of Trimethoprim/Sulfamethoxazole as PCP Prophylaxis in CTD Patients

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 21, 2014