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

Active, not recruiting

• Conditions: Invasive Fungal Infections; Hyperbaric Oxygen Therapy

• Registration Number: NCT07120581
• Lead Sponsor: Assaf-Harofeh Medical Center

Brief 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. 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

Not available

Study Timeline

• Study Start: 2024-08-04
• Study First Submitted: 2025-07-17
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-12
• Last Update Submitted: 2025-08-12
• Study First Posted: 2025-08-13
• Last Update Posted: 2025-08-13
• Primary Completion: 2025-12
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 7

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Eradication of Fungal Infectious Agent	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 Outcome Measures

Name	Time	Method
Clinical Status on Discharge- ventilation status	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
clinical status on discharge- kidney function	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)
clinical status on discharge- Kidney function	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)
clinical status on discharge- consciousness level	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
clinical status on discharge- wound status	From enrollment, baseline day 1, through study completion, an average of 4-8 weeks	Whether the patient recieved a successful skin graft
clinical status on discharge- location of discharge	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).
Adverse Events	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

Trial Locations

Locations (1)

Shamir Medical Center; 🇮🇱 Zerifin, Israel