EUCTR2012-003511-63-ES进行中（未招募）1 期
Efficacy of high doses of oral penicillin V versus high dose amoxicillin in the treatment of non-severe pneumonia treated at the adult community.PENIPNEUMO Study - PENIPNEUMO
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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
- •Patients 18 years to 65 years (inclusive).
- •Signs and symptoms of lower respiratory tract infection.
- •Radiological confirmation of the diagnosis of pneumonia or not radiological confirmation but the patient has the following symptoms: high fever (> 38.5 ° C), cough and purulent sputum and auscultation of crackles in a pulmonary focus, the researcher undertakes to confirm after inclusion pneumonia with mandatory radiological study.
- •Signature of informed consent.
- •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 168
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 42
排除标准
- •? Impaired consciousness: confused state, delirium, drowsiness, stupor or coma, at medical discretion
- •? Respiratory rate> 30 breaths / minute
- •? Heart rate> 125 beats / minute
- •? Systolic blood pressure <90 mm ??Hg or diastolic <60 mm Hg
- •? Hypersensitivity to ?-lactam
- •? O2 saturation <92%
- •? axillary temperature > 40 ° C
- •? Bronchial Asthma
- •? Pregnancy or breastfeeding
- •? Comorbidity significant: renal failure, liver cirrhosis, heart failure, chronic obstructive pulmonary disease, ischemic heart disease, stroke and / or diabetes mellitus type 1
- •? Important alteration in chest radiography: alveolar infiltrates in more than one lobe or bilateral pleural effusion or pulmonary cavitation
- •? Problems in order to meet the treatment at home: sociopathy or psychiatric problems, drug and alcohol addiction, or a family environment unsuitable
- •? Lack of tolerance to oral therapy: presence of nausea and vomiting, gastrectomy, post-surgery or frank diarrhea
- •? Immunosuppression: chronic HIV infection, transplant, neutropenic, or patients receiving immunosuppressive
- •? active Neoplasia
- •? Terminal illness
- •? Hospitalisation in the last month
- •? Taking antibiotics in the two weeks prior to the inclusion
- •? Difficulty to attend follow-up visits
- •? Refusal to participate in the study
研究者
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