Study of Clinical Efficacy of Antimicrobial Therapy Strategy Using Pragmatic Design in Idiopathic Pulmonary Fibrosis
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 513
- 试验地点
- 60
- 主要终点
- Number of Participants With First Non-elective, Respiratory Hospitalization or All-cause Mortality
研究概览
简要总结
The purpose of this study is to compare the effect of standard care, versus standard of care plus antimicrobial therapy (co-trimoxazole or doxycycline), on clinical outcomes in patients diagnosed with idiopathic pulmonary fibrosis (IPF).
详细描述
This is a randomized, un-blinded, phase III, multi-center clinical trial of an antimicrobial therapy strategy in idiopathic pulmonary fibrosis patients. Our overall hypothesis is that reducing harmful microbial impact with antimicrobial therapy will reduce the risk of non-elective, respiratory hospitalization or death in patients with Idiopathic Pulmonary Fibrosis (IPF).
Subjects will be randomized 1:1 to either receive a prescription drug voucher for oral antimicrobial therapy in the form of one double strength 160 milligrams (mg) trimethoprim/800mg sulfamethoxazole (double strength co-trimoxazole) twice daily plus folic acid 5 mg daily OR doxycycline 100mg once daily if weight < 50 kilograms (kg) or 100mg twice daily if weight > 50 kg. Patients randomized to receive antimicrobial therapy will be given co-trimoxazole unless they have an allergy, contraindication to co-trimoxazole, renal insufficiency (glomerular filtration rate (GFR) < 30 milliliters (ml)), are hyperkalemic (potassium > 5 milliequivalents(mEq)/liter(L)), or are concomitantly taking an angiotensin converting enzyme inhibitor (ACEI), angiotensin receptor blocker (ARB), or potassium sparing diuretic in which case they will receive doxycycline.
Participation in this study will be between 12 months and 36 months depending on time of enrollment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 40 years of age
- •Diagnosed with idiopathic pulmonary fibrosis (IPF) by enrolling investigator
- •Signed informed consent
排除标准
- •Received antimicrobial therapy in the past 30 days
- •Contraindicated for antibiotic therapy, including but not exclusive to:
- •Allergy or intolerance to both tetracyclines AND trimethoprim, sulfonamides or their combination
- •Allergy or intolerance to tetracyclines AND known potassium level > 5 mEq/L in the past 90 days.
- •If the enrolling physician feels the potassium level has normalized, documentation to that effect must be provided.
- •Allergy or intolerance to tetracyclines AND concomitant use of angiotensin converting enzyme inhibitor (ACEI), angiotensin receptor blocker (ARB), potassium sparing diuretic, dofetilide, methotrexate, azathioprine, mycophenolate mofetil, cyclophosphamide
- •Allergy or intolerance to tetracyclines AND known glucose-6-phosphate dehydrogenase deficiency
- •Allergy or intolerance to tetracyclines AND untreated folate or B12 deficiency
- •Allergy or intolerance to tetracyclines AND known renal insufficiency (defined as a glomerular filtration rate (GFR) < 30 ml within the previous 90 days)
- •If the enrolling physician feels the renal dysfunction has resolved, documentation to that effect must be provided.
- •Pregnant or anticipate becoming pregnant
- •Use of an investigational study agent for IPF therapy within the past 30 days, or an IV infusion with a half-life of four (4) weeks.
- •Concomitant immunosuppression with azathioprine, mycophenolate, cyclophosphamide, or cyclosporine.
结局指标
主要结局
Number of Participants With First Non-elective, Respiratory Hospitalization or All-cause Mortality
时间窗: Randomization to up to 35 months
次要结局
- Number of Participants With Death From Any Cause(Randomization to up to 35 months)
- Number of Participants With First Non-elective, Respiratory Hospitalization(Randomization to up to 35 months)
- Number of Participants With First Non-elective, All-cause Hospitalization(Randomization to up to 35 months)
- Total Number of Non-elective Respiratory Hospitalizations(Randomization to up to 35 months)
- Total Number of Non-elective All-cause Hospitalizations(Randomization to up to 35 months)
- Percent Change in Forced Vital Capacity (FVC)(Randomization to 12 months)
- Percent Change in Diffusion Capacity of Lungs for Carbon Monoxide (DLCO)(Randomization to 12 months)
- Total Number of Respiratory Infections(Randomization to up to 35 months)
- Change in UCSD-Shortness of Breath Questionnaire(Randomization to 12 months)
- Change in Fatigue Severity Scale Score(Randomization to 12 months)
- Change in Leicester Cough Questionnaire Score(Randomization to 12 months)
- Change in EuroQol Index (EQ-5D) Score(Randomization to 12 months)
- Change in ICEpop CAPability Measure for Older People (ICECAP-O) Score(Randomization to 12 months)
- Change in Short Form-12 Health Survey (SF-12) 6D Score(Randomization to 12 months)
- Change in Short Form-12 Health Survey (SF-12) Physical Score(Randomization to 12 months)
- Change in SF-12 Health Survey (SF-12) Mental Score(Randomization to 12 months)