[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100560762":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":39,"locations":44,"responsibleParty":50,"collaborators":44,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":54,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":44,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":72,"overallStatus":80,"whyStopped":44,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":44},{"fullName":5,"class":6},"Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Control group","PLACEBO_COMPARATOR","Full-course antibiotic therapy based on current guidelines (7 days).",[13],"Drug: Complete a 7-day course",{"label":15,"type":16,"description":17,"interventionNames":18},"Intervention group","ACTIVE_COMPARATOR","In the intervention group, patients will be advised to visit the center as soon as they feel better and are afebrile for a clinical assessment and C-reactive protein rapid testing after completing two full days of antibiotic.",[19],"Drug: Tailoring the course duration to the patient's needs.",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Tailoring the course duration to the patient's needs.","Patients 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.",[15],[27],"Patient-centered approach",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Complete a 7-day course","The antibiotic course must be completed (7 days at least).",[9],[33],"Completion of the antibiotic course",[35],{"name":36,"affiliation":37,"role":38},"Rosa Morros, PhD","University Institute in Primary Care Research Jordi Gol, Barcelona","STUDY_CHAIR",[40,46],{"name":41,"role":42,"phone":43,"phoneExt":44,"email":45},"Ramon Monfà, MSc","CONTACT","0034685409860",null,"rmonfa@idiapjgol.org",{"name":47,"role":42,"phone":48,"phoneExt":44,"email":49},"Ana García-Sangenís, MSc","0034638687717","agarcia@idiapjgol.org",{"type":51,"investigatorFullName":44,"investigatorTitle":44,"investigatorAffiliation":44,"oldNameTitle":44,"oldOrganization":44},"SPONSOR","100560762","phase-4-tailoring-antibiotic-duration-for-respiratory-tract-infections-in-primary-care-100560762",false,"NCT06581367","Tailoring Antibiotic Duration for Respiratory Tract Infections in Primary Care","Tailoring Antibiotic Duration for Respiratory Tract Infections in Primary Care: a Pragmatic Randomized Controlled Trial","STORM","Inclusion Criteria:\n\n* 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\n* Doctors deem beta-lactam therapy (given every eight hours for a minimum of seven days) is necessary\n\nExclusion Criteria:\n\n* RTIs different from a lower RTI or acute rhinosinusitis\n* Patients with suspected septicemia (quick Quick Sequential Organ Failure Assessment: respiratory rate ≥22 breaths\u002Fminute, systolic blood pressure \\\u003C100 mm Hg or altered mental status with a Glasgow score \\\u003C 5) ≥2\n* Patients with pneumonia and \\[Confusion, respiratory rate ≥30 breaths\u002Fminute, blood pressure \\\u003C 90\u002F60 mm Hg, or age \\>65 yr.\\] ≥1\n* Patients with very severe COPD (Forced Expiratory Volume in One Second \\\u003C30%)\n* Patients with COPD who have taken four or more antibiotic courses in the previous year, presence of significant bronchiectasis, and\u002For 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* Patients who have been hospitalized in the last two weeks\n* A working diagnosis of a non-infective disorder, such as heart failure, pulmonary embolus, esophageal reflux\n* Immunocompromised patients, such as HIV infection, patients taking immunosuppressive treatment, antineoplastic therapy, or systemic corticosteroids\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\u002Funable to understand and\u002For take part in the clinical trial","ALL","18 Years","75 Years",{"count":64,"type":65},474,"ESTIMATED","INTERVENTIONAL",[68],"PHASE4","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.",[71],"Acute Respiratory Tract Infection",[73,74,75,76,77,78,79],"Antibacterial Agents Antimicrobial Resistance","Duration","Primary Health Care","Personalized Medicine","Drugs, Customized","Drug Resistance, Microbial","Patient-Centered Care","NOT_YET_RECRUITING","2024-08-30",{"date":83,"type":84},"2024-09-03","ACTUAL",{"date":86,"type":65},"2025-10-01",{"date":88,"type":65},"2027-04-30",{"name":5,"class":6}]