Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:53 PM
Ignite Modification Date:
2025-12-24 @ 12:53 PM
NCT ID:
NCT03208361
Eligibility Criteria:
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03208361
Study Brief:
Protocol Section:
NCT03208361