Status:
NOT_YET_RECRUITING
Tailoring Antibiotic Duration for Respiratory Tract Infections in Primary Care
Lead Sponsor:
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Conditions:
Acute Respiratory Tract Infection
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
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 ...
Detailed Description
Background. Combating the rise of drug-resistant organisms and minimizing the side effects demand a shift in how we approach antibiotic therapy duration. A study focused on tailoring antibiotic length...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2027
Estimated Enrollment :
474 Patients enrolled
Trial Details
Trial ID
NCT06581367
Start Date
October 1 2025
End Date
April 30 2027
Last Update
September 3 2024
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