A Phase 3 interventional study of Dornase Alfa Inhalant Solution [Pulmozyme] and Placebos in Multiple Trauma and Respiratory Distress Syndrome, Adult, sponsored by University Hospital, Strasbourg, France. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-20.
Sponsored by University Hospital, Strasbourg, France · Phase 3, Interventional, and Treatment
Severe hypoxemia following trauma may happen in many circumstances (aspiration, ventilation-associated pneumonia, lung contusion...), most of which are not exclusively associated with a direct injury to the lungs. Severe trauma and associated musculoskeletal injuries result in the acute release of Damage-Associated Molecular Patterns (DAMPs) in plasma, many of which are made of nucleic acids. DAMPs then bind leukocytes and trigger NETosis (Neutrophil Extracellular Traps), the release of nuclear material coated with proteolytic enzymes, which ultimately promotes remote lung injury and acute respiratory distress syndrome (ARDS).
Considering that many DAMPs and all NETs are made of nucleic acids, we hypothesize that dornase alfa, a commercially available recombinant desoxyribonuclease (DNAse) could reduce DAMPs and NETs-induced lung injury in severe trauma patients under mechanical ventilation in the intensive care unit (ICU).
The primary objective is to demonstrate a reduction in the incidence of moderate to severe ARDS in severe trauma patients during the first seven ICU days from 45% to 30% by providing aerosolized dornase alfa once during the first two consecutive ICU days and compared to equivalent provision of placebo (NaCl 0,9%).
The secondary objectives are to demonstrate, by using aerosolized dornase alfa compared to placebo:
139 studies on the registry are indexed under Multiple Trauma; 32 are open to participants now.
This study's planned enrollment of 500 is above the median of 94 across 50 interventional studies indexed under Multiple Trauma.
Browse Multiple Trauma studies →University Hospital, Strasbourg, France is the lead sponsor of 999 studies on the registry; 358 are open to participants now.
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Adult (>18) patient of either sex affiliated to the National Health Service
Exclusion Criteria:
Pregnancy or breast feeding
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Dornase alfa (Pulmozyme®, Roche 2500U, 2,5mL) given by aerosol in the respiratory circuit (Aerogen solo®) within 6h at day 1 and 24 hours after on day 2.
Drug: Dornase Alfa Inhalant Solution [Pulmozyme]
NaCl 0,9%, given by aerosol in the respiratory circuit within 6h at day 1 and 24 hours after on day 2.
Drug: Placebos
Dornase alfa (Pulmozyme®, Roche 2500U, 2,5mL) given by aerosol in the respiratory circuit (Aerogen solo®) within 6h at day 1 and 24 hours after on day 2.
NaCl 0,9%, given by aerosol in the respiratory circuit within 6h at day 1 and 24 hours after on day 2.
The primary endpoint is the incidence of moderate to severe ARDS (PaO2/FiO2 < 200, according to the Berlin definition [ARDS definition task force et al. JAMA 2015; 307(23): 2526-2533]) in severe trauma patients (Injury Severity Score > 15).
Time frame: Day 0 to Day 7
Static lung compliance [mL/cmH2O]
Time frame: Day 0 to Day 7
Duration of mechanical ventilation [hours]
Time frame: Day 0 to Day 7
Length of ICU stay [hours]
Time frame: Day 0 to Day 7
Length of stay in the hospital [days]
Time frame: Day 0 to Day 7
Incidence of multi-organ failure
according SOFA (Sepsis-related Organ Failure Assessment) to quantify organ dysfunction
Time frame: Day 0 to Day 7
Incidence of Ventilator-Associated Pneumonia (VAP)
Time frame: Day 0 to Day 7
Mortality on day 28
Time frame: Day 28
Plan to share: No
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Studies of the drug tested here: Dornase alfa
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