Clinical trial • Phase IV • Infectious Disease
TETRACYCLINES for Viral respiratory tract infection
Phase IV trial of TETRACYCLINES for Viral respiratory tract infection.
Overview
- Trial Therapeutic Area
- Infectious Disease
- Trial Disease
- Viral respiratory tract infection
- Trial Stage
- Phase IV
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 12-04-2024
- First CTIS Authorization Date
- 15-05-2024
Trial design
Randomised, open-label, continuation of antibiotic therapy as instituted by the receiving physician (standard care) versus discontinuation of antibiotic therapy-controlled Phase IV trial across 12 sites in Norway.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Continuation of antibiotic therapy as instituted by the receiving physician (standard care) versus discontinuation of antibiotic therapy
- Real World Control
- Yes
- Target Sample Size
- 400
- Trial Duration For Participant
- 30
Eligibility
Recruits 400 Vulnerable population not selected. Trial includes adults (18 years or older) only. "Signed informed consent must be obtained and documented according to ICH GCP, and national/local regulations." No assent or paediatric consent procedures described..
- Vulnerable Population
- Vulnerable population not selected. Trial includes adults (18 years or older) only. "Signed informed consent must be obtained and documented according to ICH GCP, and national/local regulations." No assent or paediatric consent procedures described.
Inclusion criteria
- {"criterion_text":"- Hospitalized\n- Adults 18 year or older\n- Moderately severe disease (CRB65 ≤ 2 at time of inclusion)\n- Nasopharyngeal swab positive for influenza virus, parainfluenza virus, respiratory syncytial virus (RSV) or human metapneumovirus (hMPV)\n- On antibiotic therapy as instituted by the receiving physician from the emergency department\n- Signed informed consent must be obtained and documented according to ICH GCP, and national/local regulations."}
Exclusion criteria
- {"criterion_text":"- Requiring ICU admission at screening\n- Time from initiation of antibiotic therapy to screening >48 hours\n- Requiring high-flow oxygen therapy or non-invasive ventilation at screening\n- Signs of severe pneumonia (abscesses, massive pleural effusion, a well-defined lobar infiltrate on chest X-ray strongly suggestive of bacterial etiology)\n- Not immunocompetent (i.e. on active chemotherapy, corticosteroid therapy equaling ≥ 20 mg prednisolone daily for ≥ 4 weeks, chronic immunosuppression due to solid organ transplant)\n- SARS-CoV-2 positive\n- Bacteremia\n- Urine antigen test positive for legionella\n- Any other infection necessitating antibiotic treatment\n- Antibiotic use for assumed airway infection within the last 24 hours before admission to hospital"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Early clinical response assessed at 120 hours after randomization, defined as survival with symptom improvement without receipt of rescue antibacterial therapy","definition_or_measurement_approach":"Assessed at 120 hours after randomization; defined as survival with symptom improvement without receipt of rescue antibacterial therapy."}
Secondary endpoints
- {"endpoint_text":"- In-hospital mortality","definition_or_measurement_approach":""}
- {"endpoint_text":"- Mortality at 30 days","definition_or_measurement_approach":""}
- {"endpoint_text":"- Duration of hospital admission","definition_or_measurement_approach":""}
- {"endpoint_text":"- Days of therapy with antibiotics","definition_or_measurement_approach":""}
- {"endpoint_text":"- Rescue antibiotic therapy during hospital admission","definition_or_measurement_approach":""}
- {"endpoint_text":"- New antibiotic therapy for presumed airway infection up to 30 days after discharge","definition_or_measurement_approach":""}
- {"endpoint_text":"- Hospital readmissions up to 30 days after discharge","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 400
- Recruitment Window Months
- 65
- Consent Approach
- Signed informed consent must be obtained and documented according to ICH GCP and national/local regulations. Trial population restricted to adults (≥18 years). No assent procedures described; languages of consent documents not specified.
Geography
- Total Number Of Sites
- 12
- Total Number Of Participants
- 400
Norway
- Earliest CTIS Part Ii Submission Date
- 24-04-2024
- Latest Decision Or Authorization Date
- 09-07-2025
- Processing Time Days
- 441
- Number Of Sites
- 12
- Number Of Participants
- 400
Sites
- Site Name
- Vestfold Hospital Trust
- Department Name
- Department of Infectious Diseases
- Principal Investigator Name
- Asgeir Johannessen
- Principal Investigator Email
- asgeir.johannessen@siv.no
- Contact Person Name
- Asgeir Johannessen
- Contact Person Email
- asgeir.johannessen@siv.no
- Site Name
- Vestre Viken HF
- Department Name
- Department of Internal Medicine
- Principal Investigator Name
- Helene Hestmann
- Principal Investigator Email
- HHESTM@vestreviken.no
- Contact Person Name
- Helene Hestmann
- Contact Person Email
- HHESTM@vestreviken.no
- Site Name
- University Hospital of North Norway
- Department Name
- Department of Infectious Diseases
- Principal Investigator Name
- Vegard Skogen
- Principal Investigator Email
- vegard.skogen@unn.no
- Contact Person Name
- Vegard Skogen
- Contact Person Email
- vegard.skogen@unn.no
- Site Name
- Oslo University Hospital HF
- Department Name
- Department of Infectious Diseases
- Principal Investigator Name
- Kristian Tonby
- Principal Investigator Email
- kritonby@ous-hf.no
- Contact Person Name
- Kristian Tonby
- Contact Person Email
- kritonby@ous-hf.no
- Site Name
- St. Olavs hospital HF
- Department Name
- Department of Infectious Diseases
- Principal Investigator Name
- Jan Kristian Damås
- Principal Investigator Email
- jan.k.damas@ntnu.no
- Contact Person Name
- Jan Kristian Damås
- Contact Person Email
- jan.k.damas@ntnu.no
- Site Name
- Vestre Viken HF
- Department Name
- Department of Internal Medicine
- Principal Investigator Name
- Karl Erik Müller
- Principal Investigator Email
- kamull@vestreviken.no
- Contact Person Name
- Karl Erik Müller
- Contact Person Email
- kamull@vestreviken.no
- Site Name
- Akershus University Hospital
- Department Name
- Department of Infectious Diseases
- Principal Investigator Name
- Magnus Lyngbakken
- Principal Investigator Email
- magnus.lyngbakken@medisin.uio.no
- Contact Person Name
- Magnus Lyngbakken
- Contact Person Email
- magnus.lyngbakken@medisin.uio.no
- Site Name
- Haukeland University Hospital
- Department Name
- Emergency Care Clinic
- Principal Investigator Name
- Dagfinn Markussen
- Principal Investigator Email
- dagfinn.lunde.markussen@helse-bergen.no
- Contact Person Name
- Dagfinn Markussen
- Contact Person Email
- dagfinn.lunde.markussen@helse-bergen.no
- Site Name
- Sykehuset Telemark HF
- Department Name
- Infection Control
- Principal Investigator Name
- Marjut Anneli Sarjomaa
- Principal Investigator Email
- SARM@sthf.no
- Contact Person Name
- Marjut Anneli Sarjomaa
- Contact Person Email
- SARM@sthf.no
- Site Name
- Østfold Hospital Trust
- Department Name
- Center for Laboratory Medicine
- Principal Investigator Name
- Sara Debes
- Principal Investigator Email
- sara.foss.debes@so-hf.no
- Contact Person Name
- Sara Debes
- Contact Person Email
- sara.foss.debes@so-hf.no
- Site Name
- Sørlandet sykehus Kristiansand
- Department Name
- Department of Internal Medicine
- Principal Investigator Name
- Hans Kristian Fløystad
- Principal Investigator Email
- hans.kristian.floystad@sshf.no
- Contact Person Name
- Hans Kristian Fløystad
- Contact Person Email
- hans.kristian.floystad@sshf.no
- Site Name
- Stavanger University Hospital HF
- Department Name
- Department of Infectious Diseases
- Principal Investigator Name
- Åse Riis
- Principal Investigator Email
- ase.garlov.riis@sus.no
- Contact Person Name
- Åse Riis
- Contact Person Email
- ase.garlov.riis@sus.no
Sponsor
Primary sponsor
- Full Name
- Akershus University Hospital
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Norway
Investigational products
- Investigational Product Name
- TETRACYCLINES
- Modality
- Small molecule
- Routes Of Administration
- Other
- Investigational Product Name
- TRIMETHOPRIM AND DERIVATIVES
- Modality
- Small molecule
- Routes Of Administration
- Other
- Investigational Product Name
- OTHER ANTIBACTERIALS
- Modality
- Small molecule
- Routes Of Administration
- Other
- Investigational Product Name
- BETA-LACTAM ANTIBACTERIALS, PENICILLINS
- Modality
- Small molecule
- Routes Of Administration
- Other
- Investigational Product Name
- FLUOROQUINOLONES
- Modality
- Small molecule
- Routes Of Administration
- Other
- Investigational Product Name
- OTHER BETA-LACTAM ANTIBACTERIALS
- Modality
- Small molecule
- Routes Of Administration
- Other
- Investigational Product Name
- LINCOSAMIDES
- Modality
- Small molecule
- Routes Of Administration
- Other
- Investigational Product Name
- OTHER AMINOGLYCOSIDES
- Modality
- Small molecule
- Routes Of Administration
- Other
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