Beta-lactam antibacterials, penicillins for Acute lower respiratory tract infection | Acute rhinosinusitis

Inclusion criteria

• {"criterion_text":"- Age ranging from 18 to 75 years of age\n- Acute lower Respiratory Tract Infection or acute bacterial rhinosinusitis\n- GPs deem a beta-lactam therapy for at least seven days is necessary"}

Exclusion criteria

• {"criterion_text":"- Respiratory Tract Infections different from a lower RTI or acute rhinosinusitis\n- Inability/unable to understand and/or take part in the clinical trial\n- Currently participating in another clinical trial\n- Previously participated in the STORM study\n- Active neoplasia\n- Terminal illness\n- Institutionalized patient\n- Inability to understand and/or participate in the clinical trial\n- The doctor decides not to give an antibiotic for this RTI\n- Patients with suspected septicaemia, based on the Quick SOFA scale; patients with two or more of the following criteria must be excluded: a) respiratory rate ≥22 breaths/minute; b) systolic blood pressure <100 mm Hg, and/or c) altered mental status with a Glasgow score <15)\n- Patients with a severe community-acquired pneumonia, based on the CRB65 scale: patients with any of the following criterion must be excluded: a) confusion; b) respiratory rate ≥30 breaths/minute; c) systolic blood pressure <90 mm Hg or diastolic ≤60 mm Hg; and/or d) age ≥65 years\n- 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\n- Patients with reported allergy to beta-lactams\n- Patients who have taken an antibiotic in the previous two weeks\n- A working diagnosis of a non-infective disorder, such as heart failure, pulmonary embolus, oesophageal reflux\n- Immunocompromised patients, such as HIV infection, patients taking immunosuppressive treatment, antineoplastic therapy, or systemic corticosteroids"}

Primary endpoints

• {"endpoint_text":"- Clinical resolution is defined as disappearance of fever, disappearance or improvement in overall condition, such that no additional antimicrobial treatment is necessary. Any other clinical outcome that does not meet the definition is considered treatment failure","definition_or_measurement_approach":"Clinical resolution defined as disappearance of fever and disappearance or improvement in overall condition such that no additional antimicrobial treatment is necessary; any other outcome is treatment failure."}

Secondary endpoints

• {"endpoint_text":"- Concordance of the antibiotic doses taken with the recommended guidelines, as recorded in the questionnaire and self-registered RTI symptom diaries","definition_or_measurement_approach":"Recorded in questionnaire and self-registered RTI symptom diaries."}
• {"endpoint_text":"- Number of patients discontinuing treatment in both groups and what day they discontinue recorded in the self-registered RTI symptom diaries and eCAP","definition_or_measurement_approach":"Day of discontinuation recorded in self-registered RTI symptom diaries and eCAP."}
• {"endpoint_text":"- First day the patient feels better, as recorded in the questionnaire and self-registered RTI symptom diaries","definition_or_measurement_approach":"Patient-reported first day feeling better recorded in questionnaire and RTI diaries."}
• {"endpoint_text":"- Antibiotics others than the study medication and other symptomatic therapies within the first two weeks recorded in the self-registered RTI symptom diaries","definition_or_measurement_approach":"Use of other antibiotics/symptomatic therapies within first 2 weeks recorded in RTI diaries."}
• {"endpoint_text":"- Number of days until the last day the patient scores 5 in any of the symptoms recorded in the self-registered RTI symptom diaries","definition_or_measurement_approach":"Days until last day patient scores 5 in any symptom in RTI diaries."}
• {"endpoint_text":"- Number of days until the last day the patient scores 3 in any of the symptoms recorded in the self-registered RTI symptom diaries","definition_or_measurement_approach":"Days until last day patient scores 3 in any symptom in RTI diaries."}
• {"endpoint_text":"- Number of days until the last day the patient scores 0 in all the symptoms recorded in the self-registered RTI symptom diaries","definition_or_measurement_approach":"Days until last day patient scores 0 in all symptoms in RTI diaries."}
• {"endpoint_text":"- Number of re-attendances to any doctor for new or worsening symptoms regarding the RTI regarding the infection, within 28 days after the index consultation, registered in eCAP","definition_or_measurement_approach":"Re-attendances within 28 days after index consultation, recorded in eCAP."}
• {"endpoint_text":"- Number of complications related to the infection within 28 days after the index consultation registered in eCAP, such as visits to emergency departments and/or hospital admissions regarding the RTI","definition_or_measurement_approach":"Complications (ED visits and/or hospital admissions) within 28 days captured in eCAP."}
• {"endpoint_text":"- Number of days of work absenteeism due to the RTI registered in eCAP within the first 14 days","definition_or_measurement_approach":"Work absenteeism days within first 14 days recorded in eCAP."}
• {"endpoint_text":"- Difference in health-related quality of life on days 14 and 28, compared to baseline, measured using the EQ-5D-5L instrument","definition_or_measurement_approach":"HRQoL change from baseline at days 14 and 28 using EQ-5D-5L."}
• {"endpoint_text":"- Drug-associated adverse events related to the antibiotic assessed by review of medical notes (practice staff, the local study team, or both using a standard form to report these data) within the first 14 days","definition_or_measurement_approach":"Adverse events assessed by review of medical notes by practice staff/local study team using a standard form within first 14 days."}
• {"endpoint_text":"- Early clinical assessment based on the overall score at Day 7, defined as the total symptom score reported by the patient on that day (mean/median)","definition_or_measurement_approach":"Total symptom score reported by patient at Day 7 (analyzed as mean/median)."}

Spain

Earliest CTIS Part Ii Submission Date

05-08-2025

Latest Decision Or Authorization Date

03-10-2025

Processing Time Days

59

Number Of Sites

18

Number Of Participants

474

Primary sponsor

Full Name

Institut Universitari D Investigacio En Atencion Primaria Jordi Gol

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

Spain

Third parties

• {"country":"","full_name":"Institute of Health Carlos III (ISCIII)","duties_or_roles":"Source of monetary support","organisation_type":""}