Clinical trial • Not applicable • Infectious Disease|Rare Disease
OXYGEN for Necrotizing soft-tissue infection
Not applicable trial of OXYGEN for Necrotizing soft-tissue infection. Randomised. 500 participants.
Overview
- Trial Therapeutic Area
- Infectious Disease|Rare Disease
- Trial Disease
- Necrotizing soft-tissue infection
- Trial Stage
- Not applicable
- Drug Modality
- Other
Key dates
- Initial CTIS Submission Date
- 18-03-2025
- First CTIS Authorization Date
- 30-06-2025
Trial design
Randomised Not applicable trial across 8 sites in Belgium, Denmark, Norway and others.
- Randomised
- Yes
- Target Sample Size
- 500
- Trial Duration For Participant
- 90
Eligibility
Recruits 500 Vulnerable population selected. The trial includes ICU/critically ill patients (documents and protocol reference patients who may be sedated and on mechanical ventilation). Subject information and informed consent templates are provided for patients and for next-of-kin/relatives (multiple "L1" documents and next-of-kin/relative consent templates are included), indicating procedures for obtaining consent from the patient or from next-of-kin/relatives when appropriate. Participant information and consent documents are available in multiple local languages (see documents list)..
- Pregnancy Exclusion
- Confirmed pregnancy
- Vulnerable Population
- Vulnerable population selected. The trial includes ICU/critically ill patients (documents and protocol reference patients who may be sedated and on mechanical ventilation). Subject information and informed consent templates are provided for patients and for next-of-kin/relatives (multiple "L1" documents and next-of-kin/relative consent templates are included), indicating procedures for obtaining consent from the patient or from next-of-kin/relatives when appropriate. Participant information and consent documents are available in multiple local languages (see documents list).
Inclusion criteria
- {"criterion_text":"- Adults (age ≥18 years)\n- Surgical confirmed NSTI (defined by perioperative tissue characteristics observed by the surgeon. The diagnosis is based on sign as necrotic or deliquescent soft tissue with widespread undermining of the surrounding tissue)"}
Exclusion criteria
- {"criterion_text":"- Contraindications for HBO2 treatment according to local protocol, e.g., undrained pneumothorax\n- Confirmed pregnancy\n- Referred to palliative care\n- Previously randomized into the HOT-NSTI trial\n- Known objection by the patient to participate in the trial\n- Allergy against study drug"}
Endpoints
Primary endpoints
- {"endpoint_text":"- 30-day all-cause mortality post-randomization","definition_or_measurement_approach":"All-cause mortality within 30 days after randomization (measured post-randomization)."}
Secondary endpoints
- {"endpoint_text":"- 90-day all-cause mortality post-randomization\n- Amputation (y/n) within 7 days post-randomization\n- Quality of life at Day 90 evaluated with the 5Q-5D-5L\n- Quality of life at Day 90 evaluated with the WHO-DAS questionnaire\n- Days alive and out of hospital in the 90-day period\n- Ventilator-free days within 7 days post-randomization\n- Need for renal-replacement therapy (y/n) within 7 days\n- Number of subjects with one or more serious adverse events up to 24 hours after last treatment","definition_or_measurement_approach":"Endpoints measured within specified time windows post-randomization: 90-day all-cause mortality at 90 days; amputation recorded as yes/no within 7 days; QoL measured at Day 90 using EQ-5D-5L and WHO-DAS questionnaires; days alive and out of hospital counted over 90 days; ventilator-free days counted within first 7 days; need for renal replacement therapy recorded yes/no within 7 days; SAE count up to 24 hours after last treatment."}
Recruitment
- Planned Sample Size
- 500
- Recruitment Window Months
- 83
- Consent Approach
- Informed consent is obtained using subject information and informed consent forms (L1 documents) provided for patients; next-of-kin/relative information and consent templates are available for use when patients are unable to consent. Age eligibility is adults only (age ≥18 years). Consent materials are available in multiple local languages (documents include Danish, Dutch/Flemish, Norwegian, Finnish, Swedish, French and English versions per country files).
Methods
- Site-based recruitment at participating hospitals/units (ICU, Department of Intensive Care, Department of Anesthesia and Hyperbaric Unit, Perioperative Services) in participating countries; recruitment procedures and local arrangements documented in K1 recruitment arrangement files for specific sites/cities (e.g., Antwerp, Brugge, Genk, Turku, DK sites, Norway sites).
- Local patient information and informed consent procedures provided at site level with local-language materials (see L1 documents for country-specific participant and next-of-kin information).
Geography
- Total Number Of Sites
- 8
- Total Number Of Participants
- 980
Belgium
- Earliest CTIS Part Ii Submission Date
- 30-05-2025
- Latest Decision Or Authorization Date
- 03-09-2025
- Processing Time Days
- 96
- Number Of Sites
- 3
- Number Of Participants
- 125
Sites
- Site Name
- AZ Sint-Jan Brugge-Oostende AV
- Department Name
- Department of Intensive Care
- Principal Investigator Name
- Mathias Veys
- Principal Investigator Email
- Mathias.veys@azsintjan.be
- Contact Person Name
- Mathias Veys
- Contact Person Email
- Mathias.veys@azsintjan.be
- Site Name
- Ziekenhuis Oost-Limburg
- Department Name
- Department of Critical Care
- Principal Investigator Name
- Sofie Ordies
- Principal Investigator Email
- sofie.ordies@zol.be
- Contact Person Name
- Sofie Ordies
- Contact Person Email
- sofie.ordies@zol.be
- Site Name
- University Hospital Antwerp
- Department Name
- Department of Intensive Care
- Principal Investigator Name
- Symen Ligthart
- Principal Investigator Email
- symen.ligthart@uza.be
- Contact Person Name
- Symen Ligthart
- Contact Person Email
- symen.ligthart@uza.be
Denmark
- Earliest CTIS Part Ii Submission Date
- 07-06-2025
- Latest Decision Or Authorization Date
- 02-09-2025
- Processing Time Days
- 87
- Number Of Sites
- 1
- Number Of Participants
- 525
Sites
- Site Name
- Rigshospitalet
- Department Name
- Department of Anaesthesia, Hyperbaric Unit
- Principal Investigator Name
- Ole Hyldegaard
- Principal Investigator Email
- ole.hyldegaard@regionh.dk
- Contact Person Name
- Ole Hyldegaard
- Contact Person Email
- ole.hyldegaard@regionh.dk
Norway
- Earliest CTIS Part Ii Submission Date
- 11-06-2025
- Latest Decision Or Authorization Date
- 03-09-2025
- Processing Time Days
- 84
- Number Of Sites
- 2
- Number Of Participants
- 150
Sites
- Site Name
- Oslo University Hospital HF
- Department Name
- Department of Anesthesia and Intensive Care Medicine
- Principal Investigator Name
- Ine Røed
- Principal Investigator Email
- uxredi@ous-hf.no
- Contact Person Name
- Ine Røed
- Contact Person Email
- uxredi@ous-hf.no
- Site Name
- Haukeland University Hospital
- Department Name
- Anesthesia and Intensive Care Medicine
- Principal Investigator Name
- Torbjørn Nedreby
- Principal Investigator Email
- neto@ihelse.net
- Contact Person Name
- Torbjørn Nedreby
- Contact Person Email
- neto@ihelse.net
Finland
- Earliest CTIS Part Ii Submission Date
- 30-05-2025
- Latest Decision Or Authorization Date
- 03-09-2025
- Processing Time Days
- 96
- Number Of Sites
- 1
- Number Of Participants
- 80
Sites
- Site Name
- Turku University Hospital
- Department Name
- Perioperative Services, Intensive Care Medicine and Pain Management
- Principal Investigator Name
- Riikka Takala
- Principal Investigator Email
- riikka.takala@varha.fi
- Contact Person Name
- Riikka Takala
- Contact Person Email
- riikka.takala@varha.fi
Sweden
- Earliest CTIS Part Ii Submission Date
- 07-06-2025
- Latest Decision Or Authorization Date
- 10-09-2025
- Processing Time Days
- 95
- Number Of Sites
- 1
- Number Of Participants
- 100
Sites
- Site Name
- Karolinska University Hospital
- Department Name
- Perioperative Medicine and Intensive Care
- Principal Investigator Name
- Anders Kjellberg
- Principal Investigator Email
- anders.kjellberg@ki.se
- Contact Person Name
- Anders Kjellberg
- Contact Person Email
- anders.kjellberg@ki.se
Sponsor
Primary sponsor
- Full Name
- Rigshospitalet
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Denmark
Third parties
- {"country":"Denmark","full_name":"Frederiksberg Hospital","duties_or_roles":"sponsorDuties: code 1","organisation_type":"Hospital/Clinic/Other health care facility"}
Investigational products
- Investigational Product Name
- Medical Liquid Oxygen
- Active Substance
- OXYGEN
- Modality
- Other
- Routes Of Administration
- INHALATION
- Route
- INHALATION
- Authorisation Status
- Authorised (marketing authorisation PL15929/0009, authorisationCountryCode: GB)
- Frequency
- maxDailyDoseAmount = 2 per day
- Maximum Dose
- maxTotalDoseAmount = 5 (units as recorded: d day)
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