PER-035-01已完成未知
Multicenter, multinational, prospective, randomized and double-blind study to compare the efficacy and safety of faropenem daloxato 300 mg orally twice daily for 10 days with amoxicillin-clavulanic acid 500/125 mg orally, three times a day for 10 days in the treatment of adult patients with community-acquired pneumonia
BAYER S.A.,0 个研究点目标入组 0 人开始时间: 2001年6月28日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Male or female patients 18 years of age or older.
- •Patients with signs and symptoms of bacterial pneumonia likely to be treated appropriately with oral antibacterial therapy.
- •In order for them to be classified as patients with community-acquired bacterial pneumonia, these patients must show signs of A, B, and C:
- •A: At least one of the following elements must be presented:
- •- Fever (eg, rectal value / tympanic membrane> 38.5 ° C or oral / axillary / cutaneous temperature value> 38.0C)
- •- Hyperleukocytosis with leukocyte count (RGB)> 10,000 / mm ^ and / or> 15% immature neutrophils (non-segmented) or leukopenia with RGB count <4,500 / mm ^
- •B: At least two of the following elements must be presented:
- •- Purulent sputum or changes in sputum characteristics
- •- Dyspnea or tachypnea (respiratory rate> 20 aspirations / min.)
- •- Pleuritic chest pain
- •- Auscultatory detection as rales indicating pulmonary consolidation.
- •C. Radiological tests of infiltrate (s) indicating pneumonia;
- •Patients with community-acquired pneumonia considered clinically appropriate for treatment in outpatient settings, as well as any of the following elements:
- •- Patients currently hospitalized if hospitalization <48 hours.
- •- Patients for whom severe hospitalization is expected.
- •- Patients who are in long-term care facilities and do not require special medical treatment.
- •Women of childbearing age, including women in the postmenopausal period for less than a year who use reliable contraceptive methods during exposure to the study drug.
- •Patients who have the ability and intention to give written consent.
排除标准
- •Patients with a history of hypersensitivity to study drugs or related substances.
- •Women who are pregnant or breastfeeding.
- •Patients with a history of liver injury due to the administration of beta-lactams.
- •Patients who may suffer from aspiration pneumonia.
- •Patients requiring any concomitant inhaled or systemic antibiotic.
- •Patients requiring mechanical ventilation.
- •Patients who have received a systemic antibacterial agent for more than 24 hours during the 7 days prior to inclusion in the study.
- •Patients with concurrent and medically active pulmonary disease that may affect the outcome of the trial (eg, active pulmonary tuberculosis, lung cancer, lung abscesses, cystic fibrosis, known bronchiectasis, pleural empyema or collagen vascular diseases affecting the lungs) .
- •Patients with known neutropenia (absolute neutrophil count <1,000 cells / mm ^).
- •Patients with AIDS (guideline when CD4 count <200 cells / mm ^) or patients undergoing HAART therapy (ie highly activated antiretroviral therapy).
- •Patients with known significant renal insufficiency (ie, serum creatinine> 3.0 mg / dl [> 265 umol / l]).
- •Patients with a known liver disease or with significant hepatic impairment (ie, ALT and / or ASI and / or total bilirubin> 3 times the upper limit of the normal level).
- •Patients with severe heart failure (ie class IV NYHA classification).
- •Patients with a serious life-threatening disease whose life expectancy is less than 2 months.
- •Patients previously included in this or any other study with faropenem daloxato.
- •Patients who have taken any investigational drug in the last 30 days.
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