Invasive Fungal InfectionsNCT07120581
Hyperbaric Oxygen Therapy Used on Severely Injured Healthy Individuals With Fungal Infections
An observational study of Invasive Fungal Infections and Hyperbaric Oxygen Therapy, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Invasive Fungal Infections, Hyperbaric Oxygen Therapy
- What is being tested?
- Hyperbaric Oxygen Therapy
- How many people
- 7 participants
- Where
- 1 siteIsrael
- Study dates
- 4 Aug 2024to Dec 2025
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to our health care facility (Shamir Medical Center) and diagnosed with invasive fungal infection
Who may be able to join
- 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
Who cannot join
- Patients who did not recieve hyperbaric oxygen therapy as part of the treatment
- Patients with immunosuppression background
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hyperbaric Oxygen Therapy as Salvage Therapy for Healthy, Severely Injured, Mechanically Ventilated Invasive Fungal Infection Cases Resistant to Therapy
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?
- Being tested
- Hyperbaric Oxygen Therapy
- Keywords
- Hyperbaric Oxygen Therapy, Invasive Fungal Infection, Trauma
- Medical subject headings
- Invasive Fungal Infections, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric Oxygen TherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Hyperbaric Oxygen Therapy | Not described Receives: Other: Hyperbaric Oxygen Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eradication of Fungal Infectious Agent
The time it takes from the start of treatments and until the first negative culture was found.
Measured: From enrollment, baseline day 1, through study completion, an average of 4-8 weeks
Secondary outcomes (7)
Clinical Status on Discharge- ventilation status
what support is the patient receiving upon discharge in terms of ventilation including invasive or non-invasive ventilation, need for oxygen or room-air
Measured: From enrollment, baseline day 1, through study completion, an average of 4-8 weeks
clinical status on discharge- kidney function
the patient's kidney function assessed by presence of elevated Creatinine levels at discharge (mg\dl)
Measured: From enrollment, baseline day 1, through study completion, an average of 4-8 weeks
clinical status on discharge- Kidney function
The patient's kidney function assessed by need for dialysis (yes/no)
Measured: From enrollment, baseline day 1, through study completion, an average of 4-8 weeks
clinical status on discharge- consciousness level
evaluation of the patient's consciousness level as either alert and responsive or still requiring sedation
Measured: From enrollment, baseline day 1, through study completion, an average of 4-8 weeks
clinical status on discharge- wound status
Whether the patient recieved a successful skin graft
Measured: From enrollment, baseline day 1, through study completion, an average of 4-8 weeks
clinical status on discharge- location of discharge
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).
Measured: From enrollment, baseline day 1, through study completion, an average of 4-8 weeks
Adverse Events
description of comlications occuring during the treatment, most notably seizures during the hyperbaric oxygen treatments
Measured: From enrollment, baseline day 1, through study completion, an average of 4-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start4 Aug 2024
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Invasive Fungal InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Reudor Grinberg, Assaf-Harofeh Medical Center
- Investigators
- Shai Efrati, M.D, Study director, Assaf-Harofeh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07120581
- Sponsor's protocol ID
- 0160-24-ASF
- Status last verified
- Aug 2025
- First submitted
- 17 Jul 2025
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Arieli R, Aviner B. Acclimatization and Deacclimatization to Oxygen: Determining Exposure Limits to Avoid CNS O2 Toxicity in Active Diving. Front Physiol. 2020 Sep 4;11:1105. doi: 10.3389/fphys.2020.01105. eCollection 2020. No abstract available.
PubMed 33013472Dhingra S, Buckey JC, Cramer RA. Hyperbaric Oxygen Reduces Aspergillus fumigatus Proliferation In Vitro and Influences In Vivo Disease Outcomes. Antimicrob Agents Chemother. 2018 Feb 23;62(3):e01953-17. doi: 10.1128/AAC.01953-17. Print 2018 Mar.
PubMed 29229641Ortega MA, Fraile-Martinez O, Garcia-Montero C, Callejon-Pelaez E, Saez MA, Alvarez-Mon MA, Garcia-Honduvilla N, Monserrat J, Alvarez-Mon M, Bujan J, Canals ML. A General Overview on the Hyperbaric Oxygen Therapy: Applications, Mechanisms and Translational Opportunities. Medicina (Kaunas). 2021 Aug 24;57(9):864. doi: 10.3390/medicina57090864.
PubMed 34577787
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperbaric Oxygen Therapy as Salvage Therapy for Healthy, Severely Injured, Mechanically Ventilated Invasive Fungal Infection Cases Resistant to Therapy
- ClinicalTrials.gov ID
- NCT07120581
- Acronym / sponsor ID
- 0160-24-ASF
- Keywords
- Hyperbaric Oxygen Therapy, Invasive Fungal Infection, Trauma
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- 4 Aug 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 13 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hyperbaric Oxygen Therapy | – | Other: Hyperbaric Oxygen Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to our health care facility (Shamir Medical Center) and diagnosed with invasive fungal infection
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Patients who did not recieve hyperbaric oxygen therapy as part of the treatment
- Patients with immunosuppression background
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperbaric Oxygen TherapyHyperbaric 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. | Other | Hyperbaric Oxygen Therapy |
Primary outcome
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.
7 secondary outcomes
Clinical Status on Discharge- ventilation status
Time frame: From enrollment, baseline day 1, through study completion, an average of 4-8 weeks
clinical status on discharge- kidney function
Time frame: From enrollment, baseline day 1, through study completion, an average of 4-8 weeks
clinical status on discharge- Kidney function
Time frame: From enrollment, baseline day 1, through study completion, an average of 4-8 weeks
clinical status on discharge- consciousness level
Time frame: From enrollment, baseline day 1, through study completion, an average of 4-8 weeks
clinical status on discharge- wound status
Time frame: From enrollment, baseline day 1, through study completion, an average of 4-8 weeks
clinical status on discharge- location of discharge
Time frame: From enrollment, baseline day 1, through study completion, an average of 4-8 weeks
Adverse Events
Time frame: From enrollment, baseline day 1, through study completion, an average of 4-8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
- Background: PubMed 33013472Arieli R, Aviner B. Acclimatization and Deacclimatization to Oxygen: Determining Exposure Limits to Avoid CNS O2 Toxicity in Active Diving. Front Physiol. 2020 Sep 4;11:1105. doi: 10.3389/fphys.2020.01105. eCollection 2020. No abstract available.
- Background: PubMed 29229641Dhingra S, Buckey JC, Cramer RA. Hyperbaric Oxygen Reduces Aspergillus fumigatus Proliferation In Vitro and Influences In Vivo Disease Outcomes. Antimicrob Agents Chemother. 2018 Feb 23;62(3):e01953-17. doi: 10.1128/AAC.01953-17. Print 2018 Mar.
- Background: PubMed 34577787Ortega MA, Fraile-Martinez O, Garcia-Montero C, Callejon-Pelaez E, Saez MA, Alvarez-Mon MA, Garcia-Honduvilla N, Monserrat J, Alvarez-Mon M, Bujan J, Canals ML. A General Overview on the Hyperbaric Oxygen Therapy: Applications, Mechanisms and Translational Opportunities. Medicina (Kaunas). 2021 Aug 24;57(9):864. doi: 10.3390/medicina57090864.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shai Efrati, M.D study director
Assaf-Harofeh Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Invasive Fungal Infections and Hyperbaric Oxygen Therapy, run by Assaf-Harofeh Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eradication of Fungal Infectious Agent (time frame: From enrollment, baseline day 1, through study completion, an average of 4-8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07120581, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2025.