Study of Trimethoprim/Sulfamethoxazole as PCP Prophylaxis in CTD Patients

Sponsor

Peking Union Medical College Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT01747278

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

6.7

Patients Per Site Per Month

Study Details

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.

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

Study Design

Study Type:

Interventional

Anticipated 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 :

Aug 1, 2012

Anticipated Primary Completion Date :

Jun 1, 2013

Anticipated Study Completion Date :

Aug 1, 2013

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Documented PCP infection [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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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