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Study of Trimethoprim/Sulfamethoxazole as PCP Prophylaxis in CTD Patients

Primary Purpose

Pneumonia, Pneumocystis, Prevention & Control

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Trimethoprim/Sulfamethoxazole
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pneumonia, Pneumocystis focused on measuring Pneumocystis carinii pneumonia, prophylaxis, trimethoprim/sulfamethoxazole

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Deptment of Rheumatology, Peking Union Medical College HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Placebo

TMP/SMX

Arm Description

Patients were not treated with Trimethoprim/Sulfamethoxazole (TMP/SMX).

Patients received Trimethoprim/Sulfamethoxazole (TMP/SMX) 80 mg/400 mg p.o. every day as PCP Prophylaxis.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
December 9, 2012
Last Updated
December 9, 2012
Sponsor
Peking Union Medical College Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01747278
Brief Title
Study of Trimethoprim/Sulfamethoxazole as PCP Prophylaxis in CTD Patients
Official Title
The Safety and Effectiveness of Trimethoprim/Sulfamethoxazole as Pneumocystis Carinii Pneumonia (PCP) Prophylaxis in Patients With Connective Tissue Diseases
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Unknown status
Study Start Date
August 2012 (undefined)
Primary Completion Date
June 2013 (Anticipated)
Study Completion Date
August 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking Union Medical College Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia, Pneumocystis, Prevention & Control
Keywords
Pneumocystis carinii pneumonia, prophylaxis, trimethoprim/sulfamethoxazole

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
No Intervention
Arm Description
Patients were not treated with Trimethoprim/Sulfamethoxazole (TMP/SMX).
Arm Title
TMP/SMX
Arm Type
Experimental
Arm Description
Patients received Trimethoprim/Sulfamethoxazole (TMP/SMX) 80 mg/400 mg p.o. every day as PCP Prophylaxis.
Intervention Type
Drug
Intervention Name(s)
Trimethoprim/Sulfamethoxazole
Other Intervention Name(s)
Septra
Intervention Description
Oral Trimethoprim/Sulfamethoxazole 80 mg/400mg once daily for 12 weeks.
Primary Outcome Measure Information:
Title
Documented PCP infection
Description
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.
Time Frame
12 weeks.
Secondary Outcome Measure Information:
Title
PCP-related mortality
Description
PCP-related mortality at the end of week 12.
Time Frame
12 weeks
Title
All cause mortality
Description
All cause mortality at the end of week 12.
Time Frame
12 weeks
Title
Other infections
Description
Infections other than PCP throughout the study period.
Time Frame
12 weeks
Title
PCP-related hospitalization
Description
PCP-related hospitalization throughout the study period.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hua Chen, MD
Phone
+86-10-69158797
Email
chenhua@pumch.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fengchun Zhang, MD
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Deptment of Rheumatology, Peking Union Medical College Hospital
City
Beijing
ZIP/Postal Code
100032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fengchun Zhang, MD
Phone
+86-10-69158794
Email
ZhangFCcra@yahoo.com.cn
First Name & Middle Initial & Last Name & Degree
Fengchun Zhang, MD

12. IPD Sharing Statement

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Study of Trimethoprim/Sulfamethoxazole as PCP Prophylaxis in CTD Patients

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