Hyperbaric Oxygen Treatment in Humans With Gram Positive Cocci Endocarditis

NCT04691440 | Unknown Phase 2 DMC

• 2 other identifiers: ENDOHOT TRIAL - RH2019-000857-29
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Infectious endocarditis (IE) is defined as an infection anywhere on the endocardium, most often localised to the cardiac valves. It is an infection with an increasing incidence and in Denmark with 6-700 new cases annually. Approximately 45% of the patients must undergo cardiac surgery with replacement of infected cardiac valves by prosthetic valves. Recently, the formation of biofilms infections has drawn attention with respect to the effects of hyperbaric re-oxygenation of stricken tissues as anaerobic bacterial metabolism with low levels of activity within the biofilm environment, may be responsible for the development of antimicrobial resistance. Polymorphonuclear leukocytes (PMNs) consume available oxygen in the conversion of oxygen to ROS and in the formation of reactive nitrogen species (RNS) by inducible nitric oxide (iNOS) as PMN's are activated by bacteria. In pre-clinical context the effect of hyperbaric oxygen treatment (HBOT) in re-oxygenating biofilm related infections have been demonstrated in infected lungs with Pseudomonas aeruginosa and staphylococcus aureus endocarditis. Adjunctive HBOT has never been offered to patients with IE. However, HBOT may be associated with reduced compliance and side effects, such as equalisation problems of ears and sinuses and confinement anxiety, and the treatment is organizational challenging. On this basis the investigators suggest an initial feasibility study as the basis for a later and larger scaled randomized controlled trial of HBOT in patients with IE.

Conditions

Infectious Endocarditis

Outcome Measures

Primary Outcomes (1)

• Changes in baseline characteristics with definite IE.

  Standard clinical assesments of IE and paraclinical data

  Up to 12 weeks

Study Arms (1)

HBOT

EXPERIMENTAL

Hyperbaric oxygen breathing at 2.4 atm.abs for 90 minutes. The course of hyperbaric oxygen treatment comprises a total of 6 pressure exposures, distributed 2 times daily, for 3 days.

Drug: Hyperbaric oxygen

Interventions

Hyperbaric oxygen DRUG

The course of hyperbaric oxygen treatment comprises a total of 6 pressure exposures, distributed 2 times daily, for 3 days.

HBOT

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Left sided IE with gram positive cocci.
• IE has been diagnosed according to modified Duke Criteria.
• Patients must be stable, by means of no need for hemodynamic pressure support.
• The patient must be able to be seated for the 1.5 hour the HBOT at least two times a day for 3 days.
• The patient must be able to perform Valsalva's - or Frenzels manoeuvre - to equalize middle ear pressure. As prophylaxis, all patients will receive detumescent nose drops as Otrivin® to facilitate ear- and sinuses equilibration. In the rare event it is still not possible for the patient to equalize pressure, a paracentesis or drainage of the tympanic membrane must be performed by the ear-nose and throat (ENT) doctor. All according to daily practice.
• The upstart of HBOT must be within the first 2 weeks of relevant antibiotic IE therapy.
• If a central venous catheter has been inserted, a chest X-ray must confirm no suspicion of pneumothorax.
• Patients must be \>18-years old.

You may not qualify if:

• Claustrophobia that cannot be reversed by mild sedatives.
• Patients requiring mechanical ventilation.
• Undrained pneumothorax
• Pregnancy
• Unable to follow and understand simple commands
• Non-compliant

Sponsors & Collaborators

• Ole Hyldegaard: lead
• Rigshospitalet, Denmark: collaborator
• Herlev Hospital: collaborator

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

MeSH Terms

Conditions

Endocarditis, Subacute Bacterial

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Endocarditis, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Streptococcal Infections; Gram-Positive Bacterial Infections; Cardiovascular Infections; Cardiovascular Diseases; Endocarditis; Heart Diseases

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Study Officials

• Ole Hyldegaard, MD, PHD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ole Hyldegaard, MD, PHD

CONTACT

+4535454092; ole.hyldegaard@regionh.dk

Mia Pries-Heje, MD

CONTACT

Mia Marie Pries-Heje <mia.marie.pries-heje.01@regionh.dk>

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Consultant, MD, Ph.D., Department of HBO, Rigshospitalet

Study Record Dates

• First Submitted: December 18, 2020
• First Posted: December 31, 2020
• Study Start: December 1, 2019
• Primary Completion: July 1, 2021
• Study Completion: December 31, 2021
• Last Updated: December 31, 2020

Record last verified: 2020-12

Locations

DK (1)