Efficacy of High Doses of Oral Penicillin V Versus High Doses of Oral Amoxicillin in the Treatment of Non-severe Community-acquired Pneumonia in Adults
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Disappearance or improvement of cough
研究概览
简要总结
This study aims to evaluate wether high-dose penicillin V is as effective as high-dose amoxicillin for the treatment of non-sever community-acquired pneumonia (CAP).
详细描述
Phase III parallel-group, randomised, double blind clinical trial, performed in 31 primary healthcare centres in Spain.
The use of narrow-spectrum antibiotics is needed because of the dearth of new antimicrobials and the link observed between the consumption of broad-spectrum antibiotics and the emergence and spread of antibacterial resistance.
Objective: The aim of the present trial was to determine whether high-dose penicillin V was as effective as high-dose amoxicillin for the treatment of uncomplicated CAP in a Mediterranean adult population.
Subjects: Patients between 18-75 years with lower respiratory tract infection and radiologically confirmed diagnosis of pneumonia.
Primary outcome: Clinical resolution at day 14
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 18 years to 75 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.
排除标准
- •Impaired consciousness: confused state, delirium, drowsiness, stupor or coma, at the discretion of the investigator
- •Respiratory rate> 30 breaths / minute
- •Heart rate> 125 beats / minute
- •Systolic blood pressure <90 mm ??Hg or diastolic BP <60 mm Hg
- •Hypersensitivity to beta-Lactamics
- •O2 saturation <92%
- •Axillary temperature> 40 ° C
- •bronchial Asthma
- •Pregnancy or lactation
- •Significant comorbidities: renal failure, liver cirrhosis, heart failure, chronic obstructive pulmonary disease, ischemic heart disease diagnosed less than 6 months, stroke diagnosed less than 6 months ago and / or type 1 diabetes mellitus
- •Significant alteration in chest radiography: alveolar infiltrates in more than one lobe or bilateral pleural effusion or pulmonary cavitation
- •Problems to meet the treatment at home: sociopathy or psychiatric problems, drug and alcohol addiction, or, an unsuitable family environment
- •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 therapy
- •active malignancy
- •terminal disease
- •Hospitalization in the last month
- •Taking any systemic antibiotic in the previous three days or a full use of oral antibiotics prior to inclusion in the previous two weeks (use of urinary antiseptics is not a reason for exclusion).
- •Difficulty to attend follow-up visits
- •Refusal to participate in the study
研究组 & 干预措施
Penicillin V
Penicillin V, 1600000 IU every 8h during 10 days.
干预措施: Penicillin V (Drug)
Amoxicillin
Amoxicillin, 1 g every 8h during 10 days.
干预措施: Amoxicillin (Drug)
结局指标
主要结局
Disappearance or improvement of cough
时间窗: 14 days after inclusion
Disappearance or improvement of cough (included in the general definition of Clinical Cure)
Improvement of general condition
时间窗: 14 days after inclusion
Improvement of general condition (included in the general definition of Clinical Cure)
Disappearance of fever
时间窗: 14 days after inclusion
Disappearance of fever (included in the general definition of Clinical Cure)
Disappearance or reduction of auscultation of crackles
时间窗: 14 days after inclusion
Disappearance or reduction of auscultation of crackles (included in the general definition of Clinical Cure)
No other antimicrobial treatment necessary
时间窗: 14 days after inclusion
No other antimicrobial treatment necessary (included in the general definition of Clinical Cure
次要结局
- Radiological resolution(30 days after inclusion)
- Adverse Events(1-30 days)
- No other antimicrobial treatment necessary(30 days after inclusion)
- Total Clinical Resolution(30 days after inclusion)
- Disappearance of fever(30 days after inclusion)
- disappearance or improvement of cough(30 days after inclusion)
- improvement of general condition(30 days after inclusion)
- disappearance or reduction of auscultation of crackles(30 days after inclusion)