The rise of drug-resistant organisms and the need to minimize side effects calls for a new approach to antibiotic therapy duration. This study explores tailoring the length of antibiotic treatment to patient recovery, focusing on whether adjusting therapy based on when the patient feels better is as effective as completing the prescribed course for acute respiratory tract infections (RTIs). The investigators will enroll 474 outpatients aged 18-75 with acute RTIs across 25 Spanish healthcare centers. Patients will be randomized into two groups: one following standard full-course antibiotic therapy, and another receiving a tailored approach, where treatment may be shortened based on clinical assessments. The primary outcome is clinical efficacy at day 14. Secondary outcomes include antibiotic duration, complications, and quality of life.
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
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%)
Parallel
Tailoring the course duration to the patient's needs.
DrugPatients will be advised to visit the center as soon as they feel better and are afebrile for a clinical assessment including vital signs (temperature, blood pressure, respiratory rate, pulse, and oxygen saturation) and C-reactive protein rapid testing after completing two full days of antibiotic.
Complete a 7-day course
DrugThe antibiotic course must be completed (7 days at least).
Clinical resolution
Number of patients with disappearance of fever, disappearance or improvement in overall condition (all scores \<2), such that no additional antimicrobial treatment is necessary.
Duration of antibiotic therapy
Number of patients discontinuing treatment in both groups and what day they discontinue recorded
Doses taken
Number of doses of antibiotic taken
Duration of severe symptoms
Number of days until the last day the patient scores 5 in any of the symptoms in the RTI diary symptom
Duration of moderate symptoms
Number of days until the last day the patient scores 3 in any of the symptoms in the RTI symptom diary.
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