Tailoring Antibiotic Duration for Respiratory Tract Infections in Primary Care

Launched by FUNDACIO D'INVESTIGACIO EN ATENCIO PRIMARIA JORDI GOL I GURINA · Aug 30, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how to best treat acute respiratory tract infections (RTIs), like pneumonia and bronchitis, by adjusting the length of antibiotic treatment based on how the patient is feeling. The goal is to see if stopping antibiotics when patients feel better is just as effective as taking them for the full prescribed duration. The study will involve 474 adults, aged 18 to 75, from 25 healthcare centers in Spain, and will compare two groups: one group will follow the standard full course of antibiotics, while the other group might stop earlier if their symptoms improve.

To be eligible for the trial, participants need to have a new or worsening cough that their doctor thinks is caused by a bacterial infection, or have acute bacterial sinusitis. They should also need a specific type of antibiotic treatment. However, people with certain serious health conditions, recent hospitalizations, or who are taking other medications that could interfere with the study will not be able to participate. If you join the trial, you can expect to have your health monitored for 14 days to see how well the treatment works and how it affects your quality of life. This research could help improve how antibiotics are used, which is important in fighting drug-resistant infections.

Gender

ALL

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