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Study of Trimethoprim/Sulfamethoxazole as PCP Prophylaxis in CTD Patients

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ClinicalTrials.gov Identifier: NCT01747278
Recruitment Status : Unknown
Verified December 2012 by Fengchun Zhang, Peking Union Medical College Hospital.
Recruitment status was:  Recruiting
First Posted : December 11, 2012
Last Update Posted : December 11, 2012
Information provided by (Responsible Party):
Fengchun Zhang, Peking Union Medical College Hospital

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.

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : August 2012
Estimated Primary Completion Date : June 2013
Estimated Study Completion Date : August 2013

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. PCP-related mortality [ Time Frame: 12 weeks ]
    PCP-related mortality at the end of week 12.

  2. All cause mortality [ Time Frame: 12 weeks ]
    All cause mortality at the end of week 12.

  3. Other infections [ Time Frame: 12 weeks ]
    Infections other than PCP throughout the study period.

  4. PCP-related hospitalization [ Time Frame: 12 weeks ]
    PCP-related hospitalization throughout the study period.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01747278

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

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
Principal Investigator: Fengchun Zhang, MD Peking Union Medical College Hospital

Responsible Party: Fengchun Zhang, Professor, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT01747278     History of Changes
Other Study ID Numbers: PUMCH-CTD-PCP
First Posted: December 11, 2012    Key Record Dates
Last Update Posted: December 11, 2012
Last Verified: December 2012

Keywords provided by Fengchun Zhang, Peking Union Medical College Hospital:
Pneumocystis carinii pneumonia

Additional relevant MeSH terms:
Pneumonia, Pneumocystis
Connective Tissue Diseases
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Lung Diseases, Fungal
Pneumocystis Infections
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Antiprotozoal Agents
Antiparasitic Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP2C8 Inhibitors
Cytochrome P-450 Enzyme Inhibitors