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:
2025-12-25 @ 4:20 AM
Ignite Modification Date:
2025-12-25 @ 4:20 AM
NCT ID:
NCT02900820
Eligibility Criteria:
Inclusion Criteria: Patients with uncomplicated respiratory tract infections \[common cold, influenza, pharyngitis, rhinosinusitis, acute bronchitis, and acute exacerbations of mild-to-moderate chronic obstructive pulmonary disease\] who has previously taken any dose of antibiotic due to any of the following 3 clinical scenarios and accepts to participate in the clinical trial will be included:
* Patients diagnosed with clinical conditions for which antibiotics are not necessary;
* Patients diagnosed with a clinical condition for which antibiotics might be necessary but according to the history and clinical examination the primary health physician considers that antibiotics are not needed to be taken or the patients feel that the antibiotic regimen has not worked as expected and feel they need clinical reassessment
* Patients who have taken some doses of an antibiotic (from leftovers found in the household or obtained at the pharmacy without any medical prescription) for a clinical condition for which antibiotics are not necessary
Exclusion Criteria:
* Subjects under 18 and over 75 years of age
* Patients with confirmed bacterial infection
* Patients requiring hospital admission
* Severe impairment of signs (impairment of consciousness, respiratory rate \> 30 respirations per minute, heart rate \> 125 beats per minute, systolic blood pressure \< 90 mm Hg, diastolic blood pressure \< 60 mm Hg, temperature \> 40°C, oxygen saturation \< 92%)
* Problems to comply with treatment at home - sociopathy or psychiatric problems, drug or alcohol addiction, or within an inadequate family setting -
* Lack of tolerance to oral treatment, such as the presence of nausea and vomiting, gastrectomy, post-surgery and/or diarrhoea
* Significant comorbidity, including severe renal failure, hepatic cirrhosis, severe heart failure, immunosuppression - chronic HIV infection, transplantation, neutropenic, or patients receiving immunosuppressive drugs or corticosteroids -
* Terminal disease
* Admitted to a long-term residence
* Difficulty to attend the programmed visits
* Refusal to participate in the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02900820
Study Brief:
Protocol Section:
NCT02900820