EUCTR2007-003854-28-DE进行中（未招募）不适用
Prospective, Randomized, Double-Blind Trial to Evaluate the Efficacy and Safety of Faropenem Medoxomil 600 mg PO, BID for 10 Days Versus Clarithromycin in the Treatment of Community-Acquired Pneumonia”
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 770
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Male or non-pregnant female 18 years of age or older
- •2.Subjects with fever documented within the past 24 hours (PO >38oC/100.4oF; Axillary >37.5oC/99.5oF; TM or Rectal >38.5oC/101.2oF)
- •3.Subjects who can produce an adequate (i.e., sputum Gram stain with >25 PMNs/LPF and <10 squamous epithelial cells/LPF) and purulent (i.e., cloudy and discolored) sputum specimen
- •4.A CXR obtained within 24 hours prior to initiating IP therapy and showing the presence of a new or progressive pulmonary infiltrate(s)
- •5.The presence of one (1) or more of the following clinical findings:
- •New or increased cough
- •Dyspnea or tachypnea (RR > 20 breaths per minute [bpm] but = 30), particularly if progressive in nature
- •Pleuritic chest pain
- •Auscultatory findings on pulmonary examination of rales/rhonchi and/or evidence of pulmonary consolidation (dullness on percussion, bronchial breath sounds, or egophony)
- •6.Subjects who are able to take oral medication
- •7.If female of childbearing potential, the subject must:
- •have maintained her normal menstrual pattern during the 3 months prior to trial entry, AND
- •have taken hormonal contraceptives for at least 1 month prior to trial entry, or agree to use spermicide and barrier methods or have been using another acceptable method of contraception and agree to continue with the same method during the trial, AND
- •have had a negative urine ß- subunit hCG pregnancy test sensitive to at least 50 µU/mL of ß- hCG immediately prior to trial entry
- •NOTE:Female subjects who have a positive pregnancy test and become pregnant during the trial must be promptly withdrawn from the trial
- •8.Read and sign ICF and, if applicable, any local data privacy requirements. By signing the ICF, the subject agrees to release any medical records pursuant to all current local data privacy requirements.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Subjects with a history of hypersensitivity to faropenem medoxomil or clarithromycin or a history of an anaphylactic reaction to ß-lactams (e.g., penicillins, cephalosporins or carbapenems) or allergy to the macrolide family of antimicrobials
- •2.Subjects with a positive urinary antigen test for L. pneumophila at the Pre Therapy visit (Visit 1)
- •3.Subjects with one (1) or more of the following:
- •Respiratory rate of > 30 bpm
- •Systolic blood pressure (SBP) < 90 mm Hg or diastolic blood pressure (DBP) < 60 mm Hg
- •Altered mental status (e.g., new disorientation to person, place or time, lethargy, stupor, coma)
- •Require mechanical ventilation
- •Require vasopressors to maintain blood pressure or urinary output
- •4.Subjects with known bronchial obstruction or a history of post-obstructive pneumonia (does not exclude subjects with COPD)
- •5.Subjects with known primary or metastatic malignancy in lung and/or pleura within the past 5 years
- •6.Subjects with known or suspected bronchiectasis, cystic fibrosis, lung abscess, empyema, aspiration pneumonia, acute pulmonary embolism or collagen vascular disease affecting the lungs
- •7.Subjects with known or suspected HIV infection, opportunistic infections such as toxoplasmosis, cryptococcal meningitis, tuberculosis, histoplasmosis, Pneumocystis jiroveci pneumonia, cytomegalovirus infection, oropharyngeal candidiasis (thrush), cryptosporidiosis, Mycobacterium avium complex infection, Kaposi’s sarcoma
- •8.Subjects with known underlying condition(s) or disease(s) that would interfere with oral absorption of the IP
- •9.Subjects residing in a long-term care facility within 4 weeks of the start of the IP (e.g., nursing home, etc.)
- •10.Immunocompromised subjects, including but not limited to subjects with:
- •Known WBC count (< 2000 cells/mm3) or CD4 count of < 200 cells/mm3, or on highly active antiretroviral therapy. An HIV test is not required
- •Chronic corticosteroid therapy (> 20 mg/day of prednisone or equivalent for more than 3 months before trial entry)
- •Splenectomized subjects or subjects with known hyposplenia or asplenia
- •11.Subjects who have been treated (> 24 hours) with oral or parenteral antibiotics within 14 days prior to enrollment or who plan to take antibiotics other than IP during the trial period
- •12.Subjects who require parenteral antimicrobial therapy for the treatment of pneumonia
- •13.Subjects who have been hospitalized for > 48 hours for any cause within two weeks prior to trial entry
- •14.Subject has known renal insufficiency (calculated Creatinine Clearance [CrCl] < 30 mL/min) and/or severe hepatic insufficiency (Childs-Pugh Class C)
- •15.Subjects with life expectancy < 3 months
- •16.Subjects who have been previously treated under this Protocol
- •17.Subjects who are pregnant and/or breastfeeding
- •18.Subjects who have received any experimental drug or medical device within the previous 30 days (or are scheduled to receive any other experimental procedures during the trial period)
- •19.Employees and/or family members of the Investigator or trial center with direct involvement in the proposed trial or other trials under the direction of that Investigator or trial center
研究者
相似试验
进行中（未招募）
不适用
Prospective, Randomized, Double-Blind Trial to Evaluate the Efficacy and Safety of Faropenem Medoxomil 600 mg PO, BID for 5 Days Versus Placebo Versus Telithromycin In the Treatment of Acute Exacerbation of Chronic Bronchitis - NDAcute Exacerbation of Chronic BronchitisMedDRA version: 9.1Level: LLTClassification code 10006458Term: Bronchitis chronicEUCTR2006-003944-42-ITREPLIDYNE, INC.700
进行中（未招募）
不适用
Prospective, Randomized, Double-Blind Trial to Evaluate the Efficacy and Safety of Faropenem Medoxomil 600 mg PO, BID for 5 Days Versus Placebo in the Treatment of Acute Exacerbation of Chronic Bronchitis”EUCTR2006-003944-42-LVReplidyne, Inc.611
进行中（未招募）
不适用
Prospective, Randomized, Double-Blind Trial to Evaluate the Efficacy and Safety of Faropenem Medoxomil 600 mg PO, BID for 5 Days Versus Placebo in the Treatment of Acute Exacerbation of Chronic Bronchitis”acute exacerbation of chronic bronchitisMedDRA version: 9.1Level: LLTClassification code 10000744Term: Acute exacerbation of chronic bronchitis NOSEUCTR2006-003944-42-BGReplidyne, Inc.611
已完成
不适用
A Prospective, Randomized, Double-Blind Trial To Evaluate The Role of Topical Anaesthetics In Controlling Pain After Corneal Abrasion In The Emergency DepartmentACTRN12611000448943Southland Hospital180
尚未招募
3 期
â??A Clinical Study to Evaluate the Efficacy of Ayurvedic formulations NIA/DG/2015/01 and NIA/DG/2020/01 along with Walking in the Management of Newly Diagnosed Primary Hypertension.â??CTRI/2022/11/046970ational Institute of Ayurveda Jaipur Rajasthan