Study of Trimethoprim/Sulfamethoxazole as PCP Prophylaxis in CTD Patients

December 9, 2012 updated by: Fengchun Zhang, Peking Union Medical College Hospital

The Safety and Effectiveness of Trimethoprim/Sulfamethoxazole as Pneumocystis Carinii Pneumonia (PCP) Prophylaxis in Patients With Connective Tissue Diseases

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100032
        • Recruiting
        • Deptment of Rheumatology, Peking Union Medical College Hospital
        • Contact:
        • Principal Investigator:
          • Fengchun Zhang, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • Septra

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (ANTICIPATED)

June 1, 2013

Study Completion (ANTICIPATED)

August 1, 2013

Study Registration Dates

First Submitted

December 9, 2012

First Submitted That Met QC Criteria

December 9, 2012

First Posted (ESTIMATE)

December 11, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

December 11, 2012

Last Update Submitted That Met QC Criteria

December 9, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PUMCH-CTD-PCP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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