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 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 12:37 AM
NCT ID:
NCT06581367
Eligibility Criteria:
Inclusion Criteria:
* Either adults with a) acute cough (new cough or worsening of a previous cough) as the predominant symptom which the clinician believes to be a bacterial acute lower RTI, such as community-acquired pneumonia, acute bronchitis or acute chronic obstructive pulmonary disease (COPD) exacerbations, or b) an acute bacterial rhinosinusitis
* Doctors deem beta-lactam therapy (given every eight hours for a minimum of seven days) is necessary
Exclusion Criteria:
* RTIs different from a lower RTI or acute rhinosinusitis
* Patients with suspected septicemia (quick Quick Sequential Organ Failure Assessment: respiratory rate ≥22 breaths/minute, systolic blood pressure \<100 mm Hg or altered mental status with a Glasgow score \< 5) ≥2
* Patients with pneumonia and \[Confusion, respiratory rate ≥30 breaths/minute, blood pressure \< 90/60 mm Hg, or age \>65 yr.\] ≥1
* Patients with very severe COPD (Forced Expiratory Volume in One Second \<30%)
* Patients with COPD who have taken four or more antibiotic courses in the previous year, presence of significant bronchiectasis, and/or isolation of Pseudomonas in a previous sputum culture
* Patients with reported allergy to beta-lactams
* Patients who have taken an antibiotic in the previous two weeks
* Patients who have been hospitalized in the last two weeks
* A working diagnosis of a non-infective disorder, such as heart failure, pulmonary embolus, esophageal reflux
* Immunocompromised patients, such as HIV infection, patients taking immunosuppressive treatment, antineoplastic therapy, or systemic corticosteroids
* Currently participating in another clinical trial
* Previously participated in the STORM study
* Active neoplasia
* Terminal illness
* Institutionalized patient
* Inability/unable to understand and/or take part in the clinical trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06581367
Study Brief:
Protocol Section:
NCT06581367