Clinical trial • Not applicable • Respiratory
CEFTRIAXONE for Viral lower respiratory tract infection | Viral pneumonia
Not applicable trial of CEFTRIAXONE for Viral lower respiratory tract infection | Viral pneumonia.
Overview
- Trial Therapeutic Area
- Respiratory
- Trial Disease
- Viral lower respiratory tract infection | Viral pneumonia
- Trial Stage
- Not applicable
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 24-10-2024
- First CTIS Authorization Date
- 14-02-2025
Trial design
Randomised, open-label, standard group: rapid analysis of respiratory samples + usual care; experimental group: rapid analysis of respiratory samples + early discontinuation of antibiotics.-controlled Not applicable trial across 7 sites in France.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Standard group: rapid analysis of respiratory samples + usual care; Experimental group: rapid analysis of respiratory samples + early discontinuation of antibiotics.
- Target Sample Size
- 256
- Trial Duration For Participant
- 90
Eligibility
Recruits 256 isVulnerablePopulationSelected: false. Subject information and informed consent forms include versions for adults and for adults under curatorship/tutelle (documents titled 'L1_SIS and ICF _curatelle', '..._tutelle'), indicating provisions for obtaining consent when legal guardianship/curatorship applies; primary contact for project: Clinical project manager (DRCI-projet@chu-amiens.fr)..
- Vulnerable Population
- isVulnerablePopulationSelected: false. Subject information and informed consent forms include versions for adults and for adults under curatorship/tutelle (documents titled 'L1_SIS and ICF _curatelle', '..._tutelle'), indicating provisions for obtaining consent when legal guardianship/curatorship applies; primary contact for project: Clinical project manager (DRCI-projet@chu-amiens.fr).
Inclusion criteria
- {"criterion_text":"- Patient hospitalized for a lower respiratory infection defined as : o the presence of 2 of the following 4 signs : o hyperthermia >38°C, o hyperleukocytosis ≥12000 or ≤4000, o aspirations/purulent sputum, o rales on pulmonary auscultation indicating parenchymal involvement o associated with a pulmonary image (standard X-ray, CT or ultrasound)."}
- {"criterion_text":"- Microbiological diagnostic sample taken within 48 hours"}
Exclusion criteria
- {"criterion_text":"- Planned hospitalization < 48 h or transfer to another center within 7 days"}
- {"criterion_text":"- Patient in septic shock"}
- {"criterion_text":"- Febrile aplasia"}
- {"criterion_text":"- No diagnostic microbiological sample (>48h after admission)"}
- {"criterion_text":"- Moribund patient"}
- {"criterion_text":"- Death expected within a week"}
- {"criterion_text":"- Inhalation proven by endoscopy or eyewitness"}
- {"criterion_text":"- Purulent pleurisy, lung abscess, or other concomitant bacterial infection requiring antibiotic therapy."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Number of days without antibiotics at D30","definition_or_measurement_approach":"Measured as number of days without antibiotics at day 30 (D30)."}
Secondary endpoints
- {"endpoint_text":"- Side effects of antibiotics: (collected in the eCRF at each occurrence) o Clostridial colitis, o venitis, o diarrhea, o nausea, o vomiting, o BMR germ colonization, o allergy, o other attributable effect: specify","definition_or_measurement_approach":"Collected in the eCRF at each occurrence (as stated)."}
- {"endpoint_text":"- Other complications: o nosocomial infections, o complications of decubitus, o intra-hospital mortality from any cause, o confusion, o other complication attributable to hospitalization and the reason for hospitalization: specify","definition_or_measurement_approach":"Complications captured during hospitalization as listed."}
- {"endpoint_text":"- Mortality at M1 and M3 or autonomy: ADL and IADL score at M1 and M3 (compared to those 15 days before hospitalization)","definition_or_measurement_approach":"Mortality recorded at month 1 and month 3; autonomy assessed by ADL and IADL scores compared to baseline 15 days before hospitalization."}
- {"endpoint_text":"- Duration of hospitalization in acute care (in days)","definition_or_measurement_approach":"Measured as number of days in acute care hospitalization."}
- {"endpoint_text":"- Number of days without antibiotics at M3","definition_or_measurement_approach":"Measured as number of antibiotic-free days at month 3 (M3)."}
Recruitment
- Planned Sample Size
- 256
- Recruitment Window Months
- 27
- Consent Approach
- Informed consent is obtained using subject information sheets and informed consent forms. Documents are available for adults and for adults under curatorship/tutelle (guardianship) with multiple versions (document titles include 'L1_SIS and ICF adults', 'L1_SIS and ICF _curatelle', '..._tutelle'). Primary functional contact for project: Clinical project manager (DRCI-projet@chu-amiens.fr). Documents appear to be in French.
Geography
- Total Number Of Sites
- 7
- Total Number Of Participants
- 256
France
- Earliest CTIS Part Ii Submission Date
- 31-01-2025
- Latest Decision Or Authorization Date
- 11-03-2026
- Processing Time Days
- 404
- Number Of Sites
- 7
- Number Of Participants
- 256
Sites
- Site Name
- Centre Hospitalier Universitaire Amiens Picardie
- Department Name
- Infectious and Tropical Diseases Department
- Principal Investigator Name
- Jean-Philippe LANOIX
- Principal Investigator Email
- lanoix.jean-philippe@chu-amiens.fr
- Contact Person Name
- Jean-Philippe LANOIX
- Contact Person Email
- lanoix.jean-philippe@chu-amiens.fr
- Site Name
- Centre Hospitalier General De Soissons
- Department Name
- Internal Medicine, Infectious Diseases and Geriatrics Department
- Principal Investigator Name
- Ali HACHEMI
- Principal Investigator Email
- ali_hachemi@yahoo.fr
- Contact Person Name
- Ali HACHEMI
- Contact Person Email
- ali_hachemi@yahoo.fr
- Site Name
- Centre Hospitalier De Tourcoing
- Department Name
- Infectious Diseases Department
- Principal Investigator Name
- Olivier ROBINEAU
- Principal Investigator Email
- olivier.robineau82@gmail.com
- Contact Person Name
- Olivier ROBINEAU
- Contact Person Email
- olivier.robineau82@gmail.com
- Site Name
- Centre Hospitalier Universitaire De Lille
- Department Name
- Day Hospital Service, Multidisciplinary assessment of falls in the elderly
- Principal Investigator Name
- Bénédicte Corroyer-Simovic
- Principal Investigator Email
- Benedicte.SIMOVIC@chu-lille.fr
- Contact Person Name
- Bénédicte Corroyer-Simovic
- Contact Person Email
- Benedicte.SIMOVIC@chu-lille.fr
- Site Name
- Centre Hospitalier Universitaire Rouen
- Department Name
- Geriatric Internal Medicine Department
- Principal Investigator Name
- Alice Gioanni
- Principal Investigator Email
- alice.gioanni@chu-rouen.fr
- Contact Person Name
- Alice Gioanni
- Contact Person Email
- alice.gioanni@chu-rouen.fr
- Site Name
- Centre Hospitalier Simone Veil De Beauvais
- Department Name
- Geriatric Medicine Unit
- Principal Investigator Name
- Marion NGUON
- Principal Investigator Email
- ma.nguon@ch-beauvais.fr
- Contact Person Name
- Marion NGUON
- Contact Person Email
- ma.nguon@ch-beauvais.fr
- Site Name
- Centre Hospitalier Universitaire De Caen Normandie
- Department Name
- Infectious and Tropical Diseases Department
- Principal Investigator Name
- Anna Fournier
- Principal Investigator Email
- fournier-an@chu-caen.fr
- Contact Person Name
- Anna Fournier
- Contact Person Email
- fournier-an@chu-caen.fr
Sponsor
Primary sponsor
- Full Name
- Centre Hospitalier Universitaire Amiens Picardie
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- France
Investigational products
- Investigational Product Name
- CEFTRIAXONE
- Active Substance
- CEFTRIAXONE
- Modality
- Small molecule
- Routes Of Administration
- INJECTION
- Route
- INJECTION
- Authorisation Status
- prodAuthStatus=2 (no marketing authorisation number provided in record)
- Maximum Dose
- max daily 1 g; max total 7 g
- Investigational Product Name
- AMOXICILLIN AND BETA-LACTAMASE INHIBITOR
- Active Substance
- AMOXICILLIN SODIUM, CLAVULANIC ACID
- Modality
- Small molecule
- Routes Of Administration
- INJECTION
- Route
- INJECTION
- Authorisation Status
- prodAuthStatus=2 (no marketing authorisation number provided in record)
- Maximum Dose
- max daily 3 g; max total 21 g
- Investigational Product Name
- PIPERACILLIN AND BETA-LACTAMASE INHIBITOR
- Active Substance
- PIPERACILLIN SODIUM, TAZOBACTAM SODIUM
- Modality
- Small molecule
- Routes Of Administration
- IV INJECTION, IV INFUSION
- Route
- IV INJECTION, IV INFUSION
- Authorisation Status
- prodAuthStatus=2 (no marketing authorisation number provided in record)
- Maximum Dose
- max daily 12 g; max total 84 g
- Investigational Product Name
- PYOSTACINE 500 mg, comprimé pelliculé
- Active Substance
- PRISTINAMYCIN
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Marketing authorisation present (marketingAuthNumber: 34009 558 332-5 3, authorisationCountryCode: FR)
- Maximum Dose
- max daily 3 g; max total 21 g
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