Study of Trimethoprim/Sulfamethoxazole as PCP Prophylaxis in CTD Patients

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

Status

UNKNOWN

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01747278

Enrollment

Registered

2012-12-11

Start date

2012-08-31

Completion date

2013-08-31

Last updated

2012-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumonia, Pneumocystis, Prevention & Control

Keywords

Pneumocystis carinii pneumonia, prophylaxis, trimethoprim/sulfamethoxazole

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.

Interventions

DRUGTrimethoprim/Sulfamethoxazole

Oral Trimethoprim/Sulfamethoxazole 80 mg/400mg once daily for 12 weeks.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

China

Contacts

Primary ContactHua Chen, MD

chenhua@pumch.cn+86-10-69158797

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026