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

NCT ID: NCT07120581

Last Updated: 2025-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

7 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-04

Study Completion Date

2025-12-31

Brief Summary

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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?

Detailed Description

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Conditions

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Invasive Fungal Infections Hyperbaric Oxygen Therapy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Hyperbaric Oxygen Therapy

Hyperbaric Oxygen Therapy

Intervention Type 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.

Interventions

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Hyperbaric Oxygen Therapy

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assaf-Harofeh Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Reudor Grinberg

Intensive Care Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shai Efrati, M.D

Role: STUDY_DIRECTOR

Assaf-Harofeh Medical Center

Locations

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Shamir Medical Center

Ẕerifin, , Israel

Site Status

Countries

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Israel

References

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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.

Reference Type BACKGROUND
PMID: 33013472 (View on PubMed)

Dhingra 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.

Reference Type BACKGROUND
PMID: 29229641 (View on PubMed)

Ortega 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.

Reference Type BACKGROUND
PMID: 34577787 (View on PubMed)

Other Identifiers

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0160-24-ASF

Identifier Type: -

Identifier Source: org_study_id

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