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NCT Number: NCT07120581

Hyperbaric Oxygen Therapy Used on Severely Injured Healthy Individuals With Fungal Infections

The goal of this observational study is to learn about the effects of Hyperbaric Oxygen Therapy on healthy individual who suffer from invasive fungal infection caused by severe trauma, who do not respond to conventional treatment. The main question it aims to answer is:

Does the treatment aid in eradicating the infection and improve the overall outcome of such patients?

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Invasive Fungal Infections Bacterial Infections and Mycoses Hyperbaric Oxygen Therapy Infections Mycoses Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Shamir Medical Center

Ẕerifin, 70300, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • at least 18 year old
  • Trauma as the insult type causing the infection
  • Refractory IFI with failure to respond to standard therapy (medical and surgical)
  • Hyperbaric Oxygen Therapy as part of the treatment

Exclusion criteria

  • Patients who did not recieve hyperbaric oxygen therapy as part of the treatment
  • Patients with immunosuppression background

Treatment and study plan

Hyperbaric Oxygen Therapy

Other

Hyperbaric Oxygen Therapy at increasing pressure to 2.8 ATA for 2 hours sessions. Breaks of 5 every 20 minutes from the oxygen to air to avoid hyperoxia. Continued for the duration of the hospitalization in the ICU on a daily basis.

Primary outcomes

  1. Eradication of Fungal Infectious Agent

    Time frame: From enrollment, baseline day 1, through study completion, an average of 4-8 weeks

    The time it takes from the start of treatments and until the first negative culture was found.

Secondary outcomes

  1. Clinical Status on Discharge- ventilation status

    Time frame: From enrollment, baseline day 1, through study completion, an average of 4-8 weeks

    what support is the patient receiving upon discharge in terms of ventilation including invasive or non-invasive ventilation, need for oxygen or room-air

  2. clinical status on discharge- kidney function

    Time frame: From enrollment, baseline day 1, through study completion, an average of 4-8 weeks

    the patient's kidney function assessed by presence of elevated Creatinine levels at discharge (mg\\dl)

  3. clinical status on discharge- Kidney function

    Time frame: From enrollment, baseline day 1, through study completion, an average of 4-8 weeks

    The patient's kidney function assessed by need for dialysis (yes/no)

  4. clinical status on discharge- consciousness level

    Time frame: From enrollment, baseline day 1, through study completion, an average of 4-8 weeks

    evaluation of the patient's consciousness level as either alert and responsive or still requiring sedation

  5. clinical status on discharge- wound status

    Time frame: From enrollment, baseline day 1, through study completion, an average of 4-8 weeks

    Whether the patient recieved a successful skin graft

  6. clinical status on discharge- location of discharge

    Time frame: From enrollment, baseline day 1, through study completion, an average of 4-8 weeks

    where were the patients discharged to- regular inpatient ward, a different medical center and which department (ICU or regular inpatient), rehabilitation center or not discharged (in case of death during the hospitalization).

  7. Adverse Events

    Time frame: From enrollment, baseline day 1, through study completion, an average of 4-8 weeks

    description of comlications occuring during the treatment, most notably seizures during the hyperbaric oxygen treatments

Sponsors and collaborators

Lead sponsor

Assaf-Harofeh Medical Center

Other Gov

Registry information

Official study title

Hyperbaric Oxygen Therapy as Salvage Therapy for Healthy, Severely Injured, Mechanically Ventilated Invasive Fungal Infection Cases Resistant to Therapy

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 13, 2025
Registry last updated
Aug 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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