Efficacy of penicillin versus hi amoxicillin in the pneumonia treated

Phase 1

• Conditions: patients between 18-65 years with lower respiratory tract infection and radiologically confirmed diagnosis of pneumonia; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2012-003511-63-ES
• Lead Sponsor: IDIAP Jordi Gol

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09-14
• Last Update Posted: 17 May 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

? 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified