[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100533705":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":80,"locations":87,"responsibleParty":312,"collaborators":106,"id":314,"slug":315,"hasResults":316,"nctId":317,"briefTitle":318,"officialTitle":319,"acronym":320,"eligibilityCriteria":321,"healthyVolunteers":316,"sex":322,"minAge":323,"maxAge":106,"enrollmentInfo":324,"targetDuration":106,"studyType":327,"phases":328,"briefSummary":330,"conditions":331,"keywords":333,"overallStatus":90,"whyStopped":106,"lastUpdateSubmitDate":335,"lastUpdatePostDateStruct":336,"startDateStruct":339,"completionDateStruct":341,"leadSponsor":343,"locationsCount":344},{"fullName":5,"class":6},"Nantes University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Amoxicillin","EXPERIMENTAL","Amoxicillin is an antibiotic treatment approved in France and in many countries.\n\nThe investigational medicinal products (IMPs) are:\n\n\\- Amoxicillin capsules : Formulated as a 500 mg capsules for PO administration (commercially available). Description in IMP file.\n\nAmoxicillin capsules contain compendial excipients listed in the Summary Product Characteristics (SmPC), current version, and are kept in a cool dry place where the temperature stays at 15- 25°C.\n\n\\- Amoxicillin IV vials : Formulated as a 1000 mg vial for IV administration (commercially available). Description in IMP file.\n\nAmoxicillin IV vials contain compendial excipient listed in the Summary Product Characteristics (SmPC), current version, and are kept in a cool dry place where the temperature stays at 15-25°C.",[13],"Drug: Amoxicillin",{"label":15,"type":16,"description":17,"interventionNames":18},"Amoxicillin\u002Fclavulanate","ACTIVE_COMPARATOR","Amoxicillin\u002Fclavulanate is recommended by French and European guidelines for the treatment of patients aged 65 years or older, and hospitalized in a non-ICU ward, as reported above.\n\nThe active comparators (IMPs) are:\n\n\\- Amoxicillin\u002Fclavulanate tablets: Formulated as a tablet for PO administration (commercially available). Description in IMP file. Tablets contain 500 mg of amoxicillin trihydrate and 62.5 mg of clavulanate. Amoxicillin\u002Fclavulanate tablets contain compendial excipients listed in the Summary Product Characteristics (SmPC), current version, and are kept in a cool dry place where the temperature stays at 15-25°C.\n\n\\- Amoxicillin\u002Fclavulanate vials Vials contain 1000 mg of amoxicillin and 200 mg of clavulanate. Description in IMP file.\n\nAmoxicillin\u002Fclavulanate vials contain compendial excipients listed in the Summary Product Characteristics (SmPC), current version, and are kept in a cool dry place where the temperature stays at 15-25°C",[19],"Drug: Amoxicillin\u002Fclavulanate",[21,27],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Participants will be randomized to IV\u002Foral amoxicillin or IV\u002Foral amoxicillin\u002Fclavulanate for 5 days. Both agents are approved for treatment of respiratory infections.\n\nAmoxicillin PO: The dose is two capsule of 500 mg every 8 hours (that is 3 times daily).\n\nAmoxicillin IV: The dose is 1 g every 8 hours (that is 3 times daily)",[9],[26],"Experimental drug",{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":30},"Participants will be randomized to IV\u002Foral amoxicillin or IV\u002Foral amoxicillin\u002Fclavulanate for 5 days. Both agents are approved for treatment of respiratory infections.\n\nAmoxicillin\u002Fclavulanate PO: The dose is two tablets of 500 mg\u002F62.5 mg every 8 hours (that is 3 times daily, approved standard dose) Amoxicillin\u002Fclavulanate IV: The dose is 1 g\u002F200 mg every 8 hours (that is 3 times daily, approved standard dose)",[15],[31],"active comparator drug",[33,37,39,42,44,47,50,52,55,57,60,63,65,68,71,73,75,78],{"name":34,"affiliation":35,"role":36},"Frederic BALEN, Doctor","Toulouse UH","PRINCIPAL_INVESTIGATOR",{"name":38,"affiliation":35,"role":36},"Guillaume MARTIN-BLONDEL, Doctor",{"name":40,"affiliation":41,"role":36},"Perrine DUMANOIR, Doctor","Grenoble Hospital",{"name":43,"affiliation":41,"role":36},"VIGLINO Damien, Doctor",{"name":45,"affiliation":46,"role":36},"Alexandrine VIDAL, Doctor","Perigueux Hospital",{"name":48,"affiliation":49,"role":36},"Delphine PLARD, Doctor","Angers UH",{"name":51,"affiliation":49,"role":36},"Rafaël MAHIEU, Doctor",{"name":53,"affiliation":54,"role":36},"Anne-Laure FERAL-PIERSSENS, Doctor","Avicenne AP-HP",{"name":56,"affiliation":54,"role":36},"Frederic MECHAI, Doctor",{"name":58,"affiliation":59,"role":36},"Aurelie DAUMAS, Professor","Marseille Timone Hospital",{"name":61,"affiliation":62,"role":36},"Dominique MERRIEN, Doctor","CHD La Roche sur Yon",{"name":64,"affiliation":62,"role":36},"Sylvain LE GENTIL, Doctor",{"name":66,"affiliation":67,"role":36},"Pierre BARSI, Doctor","Vannes Hospital Bretagne Atlantic",{"name":69,"affiliation":70,"role":36},"Rozenn LE BERRE, Doctor","Brest Hospital",{"name":72,"affiliation":70,"role":36},"Sylvain JAFFUEL, Doctor",{"name":74,"affiliation":35,"role":36},"Xavier DUBUCS, Doctor",{"name":76,"affiliation":77,"role":36},"Matthieu THIBAULT, Doctor","Saint-Nazaire Hospital",{"name":79,"affiliation":77,"role":36},"BOISSEAU Dorothée, Doctor",[81],{"name":82,"role":83,"phone":84,"phoneExt":85,"email":86},"Emmanuel MONTASSIER, Professor","CONTACT","02 53 48 20 38","+33","emmanuel.montassier@chu-nantes.fr",[88,107,116,129,139,152,161,174,183,196,205,218,227,240,254,267,280,289,299],{"facility":89,"status":90,"city":91,"state":92,"zip":93,"country":92,"countryCode":94,"cosmosGeoPoint":95,"geoPoint":100,"contacts":101},"CH Saint-Nazaire","RECRUITING","Saint-Nazaire","France","44600","FR",{"type":96,"coordinates":97},"Point",[98,99],-2.2179,47.27506,{"lat":99,"lon":98},[102,105],{"name":76,"role":83,"phone":103,"phoneExt":85,"email":104},"0272278174","m.thibault@ch-saintnazaire.fr",{"name":76,"role":36,"phone":106,"phoneExt":106,"email":106},null,{"facility":89,"status":90,"city":91,"state":92,"zip":93,"country":92,"countryCode":94,"cosmosGeoPoint":108,"geoPoint":110,"contacts":111},{"type":96,"coordinates":109},[98,99],{"lat":99,"lon":98},[112],{"name":113,"role":83,"phone":114,"phoneExt":85,"email":115},"Dorothée BOISSEAU, Doctor","0272278434","d.boisseau@ch-saintnazaire.fr",{"facility":117,"status":90,"city":118,"state":106,"zip":106,"country":92,"countryCode":94,"cosmosGeoPoint":119,"geoPoint":123,"contacts":124},"Chu Angers","Angers",{"type":96,"coordinates":120},[121,122],-0.55202,47.47156,{"lat":122,"lon":121},[125],{"name":126,"role":83,"phone":127,"phoneExt":85,"email":128},"Delphine PLARD, MD","0241353637","delphine.plard@chu-angers.fr",{"facility":130,"status":90,"city":118,"state":106,"zip":106,"country":92,"countryCode":94,"cosmosGeoPoint":131,"geoPoint":133,"contacts":134},"CHU Angers",{"type":96,"coordinates":132},[121,122],{"lat":122,"lon":121},[135],{"name":136,"role":83,"phone":137,"phoneExt":85,"email":138},"Rafaël MAHIEU, MD","0241353930","rafael.mahieu@chu-angers.fr",{"facility":140,"status":90,"city":141,"state":106,"zip":106,"country":92,"countryCode":94,"cosmosGeoPoint":142,"geoPoint":146,"contacts":147},"CHU Avicenne AP-HP","Bobigny",{"type":96,"coordinates":143},[144,145],2.45012,48.90982,{"lat":145,"lon":144},[148],{"name":149,"role":83,"phone":150,"phoneExt":85,"email":151},"Anne-Laure FERAL-PIERSSENS, MD","0148955555","anne-laure.feral-pierssens@aphp.fr",{"facility":140,"status":90,"city":141,"state":106,"zip":106,"country":92,"countryCode":94,"cosmosGeoPoint":153,"geoPoint":155,"contacts":156},{"type":96,"coordinates":154},[144,145],{"lat":145,"lon":144},[157],{"name":158,"role":83,"phone":159,"phoneExt":85,"email":160},"Frederic MECHAI, MD","0148955428","frederic.mechai@aphp.fr",{"facility":162,"status":90,"city":163,"state":106,"zip":106,"country":92,"countryCode":94,"cosmosGeoPoint":164,"geoPoint":168,"contacts":169},"CHRU Brest","Brest",{"type":96,"coordinates":165},[166,167],-4.48628,48.39029,{"lat":167,"lon":166},[170],{"name":171,"role":83,"phone":172,"phoneExt":85,"email":173},"Sylvain JAFFUEL, MD","0298347213","sylvain.jaffuel@chu-brest.fr",{"facility":162,"status":90,"city":163,"state":106,"zip":106,"country":92,"countryCode":94,"cosmosGeoPoint":175,"geoPoint":177,"contacts":178},{"type":96,"coordinates":176},[166,167],{"lat":167,"lon":166},[179],{"name":180,"role":83,"phone":181,"phoneExt":85,"email":182},"Rozenn LE BERRE, MD","029822333","rozenn.leberre@chu-brest.fr",{"facility":184,"status":90,"city":185,"state":106,"zip":106,"country":92,"countryCode":94,"cosmosGeoPoint":186,"geoPoint":190,"contacts":191},"CHD Vendée","La Roche-sur-Yon",{"type":96,"coordinates":187},[188,189],-1.42757,46.66974,{"lat":189,"lon":188},[192],{"name":193,"role":83,"phone":194,"phoneExt":85,"email":195},"Sylvaine LE GENTIL, MD","0251446378","sylvain.legentil@ght85.fr",{"facility":184,"status":90,"city":185,"state":106,"zip":106,"country":92,"countryCode":94,"cosmosGeoPoint":197,"geoPoint":199,"contacts":200},{"type":96,"coordinates":198},[188,189],{"lat":189,"lon":188},[201],{"name":202,"role":83,"phone":203,"phoneExt":85,"email":204},"Dominique MERRIEN, MD","0251446385","dominique.merrien@ght85.fr",{"facility":206,"status":90,"city":207,"state":106,"zip":106,"country":92,"countryCode":94,"cosmosGeoPoint":208,"geoPoint":212,"contacts":213},"CHU Grenoble-Alpes","La Tronche",{"type":96,"coordinates":209},[210,211],5.74629,45.20507,{"lat":211,"lon":210},[214],{"name":215,"role":83,"phone":216,"phoneExt":85,"email":217},"Damien VIGLINO, MD","0476766784","DViglino@chu-grenoble.fr",{"facility":206,"status":90,"city":207,"state":106,"zip":106,"country":92,"countryCode":94,"cosmosGeoPoint":219,"geoPoint":221,"contacts":222},{"type":96,"coordinates":220},[210,211],{"lat":211,"lon":210},[223],{"name":224,"role":83,"phone":225,"phoneExt":85,"email":226},"Perrine DUMANOIR, MD","0476767088","PDumanoir@chu-grenoble.fr",{"facility":228,"status":90,"city":229,"state":106,"zip":106,"country":92,"countryCode":94,"cosmosGeoPoint":230,"geoPoint":234,"contacts":235},"Assistance Publique Hopitaux De Marseille","Marseille",{"type":96,"coordinates":231},[232,233],5.38107,43.29695,{"lat":233,"lon":232},[236],{"name":237,"role":83,"phone":238,"phoneExt":85,"email":239},"Aurélie DAUMAS, MD","0491388719","aurelie.daumas@ap-hm.fr",{"facility":241,"status":90,"city":242,"state":106,"zip":106,"country":92,"countryCode":94,"cosmosGeoPoint":243,"geoPoint":247,"contacts":248},"CHU de Nantes","Nantes",{"type":96,"coordinates":244},[245,246],-1.55336,47.21725,{"lat":246,"lon":245},[249,252],{"name":250,"role":83,"phone":251,"phoneExt":85,"email":86},"Emmanuel MONTASSIER, MD","0253482038",{"name":253,"role":36,"phone":106,"phoneExt":106,"email":106},"Emmanuel Montassier, MD",{"facility":255,"status":90,"city":256,"state":106,"zip":106,"country":92,"countryCode":94,"cosmosGeoPoint":257,"geoPoint":261,"contacts":262},"CH Perigueux","Périgueux",{"type":96,"coordinates":258},[259,260],0.71439,45.18691,{"lat":260,"lon":259},[263],{"name":264,"role":83,"phone":265,"phoneExt":85,"email":266},"Alexandrine VIDAL, MD","0553452525","alexandrine.vidal@ch-perigueux.fr",{"facility":268,"status":90,"city":269,"state":106,"zip":106,"country":92,"countryCode":94,"cosmosGeoPoint":270,"geoPoint":274,"contacts":275},"CHRU - TOULOUSE Hôpital Purpan","Toulouse",{"type":96,"coordinates":271},[272,273],1.44367,43.60426,{"lat":273,"lon":272},[276],{"name":277,"role":83,"phone":278,"phoneExt":85,"email":279},"Frederic BALEN, MD","0561772579","balen.f@chu-toulouse.fr",{"facility":268,"status":90,"city":269,"state":106,"zip":106,"country":92,"countryCode":94,"cosmosGeoPoint":281,"geoPoint":283,"contacts":284},{"type":96,"coordinates":282},[272,273],{"lat":273,"lon":272},[285],{"name":286,"role":83,"phone":287,"phoneExt":85,"email":288},"Guillaume MARTIN-BLONDEL, MD","0561779699","martin-blondel.g@chu-toulouse.fr",{"facility":290,"status":90,"city":269,"state":106,"zip":106,"country":92,"countryCode":94,"cosmosGeoPoint":291,"geoPoint":293,"contacts":294},"CHRU TOULOUSE - Hôpital Rangueuil",{"type":96,"coordinates":292},[272,273],{"lat":273,"lon":272},[295],{"name":296,"role":83,"phone":297,"phoneExt":85,"email":298},"Xavier DUBUCS, MD","0561775919","dubucs.x@chu-toulouse.fr",{"facility":300,"status":90,"city":301,"state":106,"zip":106,"country":92,"countryCode":94,"cosmosGeoPoint":302,"geoPoint":306,"contacts":307},"Centre Hospitalier Bretagne Atlantique","Vannes",{"type":96,"coordinates":303},[304,305],-2.76205,47.65688,{"lat":305,"lon":304},[308],{"name":309,"role":83,"phone":310,"phoneExt":85,"email":311},"Pierre BARSI, MD","0297014893","pierre.barsi@ch-bretagne-atlantique.fr",{"type":313,"investigatorFullName":106,"investigatorTitle":106,"investigatorAffiliation":106,"oldNameTitle":106,"oldOrganization":106},"SPONSOR","100533705","phase-3-amoxicillin-alone-versus-amoxicillinclavulanate-for-community-acquired-pneumonia-in-patients-aged-65-years-or-older-and-hospitalized-in-a-non-intensive-care-unit-ward-100533705",false,"NCT06229288","Amoxicillin Alone Versus Amoxicillin\u002FClavulanate for Community-acquired Pneumonia in Patients Aged 65 Years or Older, and Hospitalized in a Non-intensive Care Unit Ward","Amoxicillin Alone Versus Amoxicillin\u002FClavulanate for Community-acquired Pneumonia in Patients Aged 65 Years or Older, and Hospitalized in a Non-intensive Care Unit Ward: a Non-inferiority Randomized Controlled Trial","CAPTAIN","Inclusion Criteria:\n\n1. Patient aged 65 years or older with or without comorbidities defined by chronic diseases in immunocompetent patients,\n2. Patient admitted to the hospital for a CAP defined by at least two clinical signs of pneumonia (cough, sputum production, dyspnea, tachypnea, or pleuritic pain, abnormal lung auscultatory sounds, fever (temperature \\> 38°C) or hypothermia (\\\u003C36°C)), and had radiological evidence of a new infiltrate confirming pneumonia\n3. Patient understanding oral and written French\n4. Written informed consent obtained from patient prior to participation in the study (if the patient is unable to express in writing: consent by a trusted person).\n5. Patients should be able to call and to answer to a phone call or to be with a relative who can help him to call or to answer questions notably raised by a medical staff belonging to the investigational site\n\nExclusion Criteria:\n\n1. Signs of severe CAP (abscess, massive pleural effusion, serious chronic respiratory insufficiency, ICU admission)\n2. Patient requiring ICU admission,\n3. Estimated Glomerular Filtration Rate \\\u003C 30 ml\u002Fmin,\n4. Known immunosuppression (asplenia, neutropenia, agammaglobulinemia, transplant, myeloma, lymphoma, known HIV and CD4\\\u003C200\u002Fmm3),\n5. Exacerbation of chronic obstructive pulmonary disease,\n6. Life-threatening state expected to lead to possible imminent death,\n7. Suspected atypical bacteria requiring combined antibiotics therapy,\n8. Legionella suspected,\n9. Subjects with clinical or epidemiological environment leading to suspect a healthcare associated pneumonia with antibiotic resistant pathogen (including long-term care facility)\n10. Patient known to be colonized with Pseudomonas aeruginosa or Enterobacteriaceae in the respiratory tract,\n11. Suspicion of aspiration pneumonia,\n12. Administration of any antibiotic treatment for more than 24 hours before inclusion,\n13. History of jaundice\u002Fhepatic impairment associated with amoxicillin\u002Fclavulanate acid,\n14. History of bacterial pneumonia less than 1 month prior to study inclusion\n15. History of hypersensitivity or allergy to beta-lactam or to any excipients included in study antibiotics,\n16. Subject without health insurance,\n17. Subject without home address or difficulty in terms of follow-up (vacation, job transfer, geographical distance, lack of motivation),\n18. Patient under judicial protection,\n19. Diagnosis confirmed of SAR-Cov2 infection (PCR Test, covid antigen rapid test, chest computed tomography (CT) scan),\n20. Participation to another interventional study and having an exclusion period that is still in force during the screening phase or expected participation to another interventional study during participation to the CAPTAIN study","ALL","65 Years",{"count":325,"type":326},326,"ESTIMATED","INTERVENTIONAL",[329],"PHASE3","Reduce inappropriate antibiotic use is a priority of public health agencies. Community-acquired pneumonia (CAP) is one of the most important indications for antibiotic prescriptions.\n\nIn the majority of the studies of CAP, there is a large proportion of cases with no pathogen identified. Thus, the choice of the empirical antibiotic depends on the most likely pathogen, individual risk factors, comorbidities, and allergies.\n\nPatients aged 65 years or older are often treated with amoxicillin\u002Fclavulanate or with another broad-spectrum antibiotic (third-generation cephalosporins, antipneumococcal fluoroquinolone). However, broad-spectrum antibiotic prescription in CAP is debated and concerns exist about side-effects and selective pressure for resistance. Due to lack of head-to-head antibiotic comparisons, a recent Cochrane review concluded that current evidence from Randomized Clinical Trials (RCTs) is insufficient to make evidence-based recommendations for the choice for antibiotic to be used, highlighting an important evidence gap.",[332],"Community-acquired Pneumonia",[334,9,15],"Community-acquired pneumonia","2026-04-02",{"date":337,"type":338},"2026-04-08","ACTUAL",{"date":340,"type":338},"2024-04-25",{"date":342,"type":326},"2027-05-25",{"name":5,"class":6},19]