InfectionNCT04787575
Oxygen-ozone Therapy Plus Antibiotic Therapy in the Treatment of Infections Secondary to Implant of Orthopaedic Devices
A study testing Oxygen-ozone therapy in people with Infection, run by Società Scientifica Internazionale di Ossigeno Ozono Terapia at 6 sites in Italy.
Trial summary
This is an open-label, multicentre, randomized, parallel group study to evaluate the efficacy of treatment with oxygen-ozone therapy plus oral antibiotic therapy, in comparison with oral antibiotic therapy alone, in the proportion of patients with resolution/improvement of signs and symptoms of infection of the wound… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection
- What is being tested?
- Oxygen-ozone therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 6 sitesItaly
- Study dates
- 24 Jan 2024to Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- Signed written informed consent;
- Male or female aged ≥ 18 years;
- Patient having undergone surgery for implant of an orthopaedic device in the previous 8 weeks;
- Presence of at least one (but no more than 3) post-operative wounds in the site of surgery (ulcers, eschars, sores);
- Presence of at least one symptom (pain, burning, redness and malodour) and at least one sign (erythema, local warmth, swelling, purulent secretion) of infection of at least moderate intensity (score ≥ 2) in the target lesion at the screening visit (Visit 1), to be confirmed again at the baseline visit (Visit 2);
- Wound area of the target lesion ≤ 100 cm2;
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- Patient with presence at least one pathogen identified in the swab collection in the target lesion, which is amenable to be eradicated with oral antibiotic therapy;
- In case of multiple wounds (however not more than three), non-target lesions must not overlap with the target one (i.e. the largest one);
- Patient able to perform the wound self-care at home or care by his/her primary caregiver;
- Willing to refrain from all non-permitted concomitant medication from the screening visit through to the entire study duration.
- Female subjects of childbearing potential must have a negative urinary pregnancy test at Screening and must practice a reliable method of contraception throughout the study;
- Patient able to read and understand the study procedures, the requirements for follow-up visits, willing to provide information at the scheduled evaluations and willing, able and ensuring to comply with the study requirements for the whole study period.
Who cannot join
- Wounds without signs of localized infection;
- Presence of more than four wounds;
- Presence of one or more wounds with area > 100 cm2;
- Presence of undermining wounds;
- Patients with favism, i.e. deficiency of the glucose-6-phosphate dehydrogenase (G6PD) enzyme;
- Patients with uncontrolled hyperthyroidism;
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- Patients with history of connective tissue disease, e.g., mixed connective tissue disease;
- Patients with active malignant disease;
- Patients with other clinically significant diseases, or other major diseases deemed clinically significant by the Investigator or which in the opinion of the Investigator would interfere with the study procedures or study outcome;
- Patients candidate to any surgery during the overall study duration;
- Treatment with topical corticosteroids in the previous 4 weeks and/or with systemic corticosteroids in the previous 7 days;
- Treatment with any hydrating and/or moisturizing cream in the previous 24 hours.
- Patients on treatment with chemotherapeutic agents, radiation therapy or immunosuppressive therapies;
- Patients with contraindications to antibiotic therapy;
- Pregnant, breastfeeding women and female child-bearing potential who are not using a highly effective method of birth control and not willing to use it during the participation to the study;
- Participation in any clinical research study evaluating another investigational drug or device within 30 days prior to consenting to study entry;
- Patient unable to understand informed consent or having a high probability of non-compliance with the study procedures and or non-completion of the study according to investigator's judgement.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Italy6 sites, 6 recruiting
- Not yet recruiting
Ospedali Riuniti Torrette
Ancona
Antonio Pompilio Gigante, a.gigante@univpm.it
- Recruiting
Pineta Grande Hospital
Castel Volturno, Caserta
Antonio Guastafierro, drantonio.guastafierro@gmail.com
- Not yet recruiting
Università Federico II
Naples
Andrea Cozzolino, andrea.cozzolino@hotmail.it
- Not yet recruiting
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone di Palermo
Palermo
Mario Barbagallo, mario.barbagallo@unipa.it
- Not yet recruiting
Fondazione IRCCS Policlinico San Matteo
Pavia
Maria Benedetta Mascia, bennymascia@hotmail.com
- Not yet recruiting
Casa Di Cura Citta' Di Roma
Roma
Riccardo Barchetta, riccardo.barchetta@gmail.com
About this study
Official title: Open-label, Multicentre, Randomized, Parallel Group Study to Assess the Efficacy and Safety of Oxygen-ozone Therapy Plus Oral Antibiotic Therapy in the Treatment of Infections Secondary to Implant of Orthopaedic Devices
This is an open-label, multicentre, randomized, parallel group study to evaluate the efficacy of treatment with oxygen-ozone therapy plus oral antibiotic therapy, in comparison with oral antibiotic therapy alone, in the proportion of patients with resolution/improvement of signs and symptoms of infection of the wound (e.g. ulcer, eschar, sore) in the target lesion after 14 days of treatment, in patients with infections secondary to implant of orthopaedic devices.
Read the detailed description
This will be an open-label, multicentre, randomized, parallel group study. The study plan will include a screening visit (Visit 1, Day -7/-3) in which patients will be screened on the basis of inclusion/exclusion criteria and clinically evaluated.
At the end of the 3-7 days of run-in (Visit 2, Baseline visit, Day 0), patient still eligible will be randomised to one of the two following treatment groups:
- Oxygen-ozone therapy SIOOT plus antibiotic therapy
- Antibiotic therapy
Patients in both groups will receive oral antibiotic therapy, which will be prescribed at discretion of the Investigator, based on the results of the colture of the swab collected in the target lesion at the screening visit (and later, if needed) and the associated antibiogram.
Follow-up visits will be performed after 7 days (Visit 3, Day 7), 14 days (Visit 4, Day 14), 28 days (Visit 5, Day 28) and 42 days (Visit 6, End of study, Day 42) from the start of treatment.
A visit window of ± 2 days for the date of Visits 3-5 and of ± 3 days for the date of Visits 6 will be allowed.
Patients prematurely discontinued from the study will perform an 'Early termination visit', in which procedures schedule for Visit 6 (End of study, Day 42) will be performed. In case of premature study discontinuation, the Investigator will duly record the reason for premature withdrawal in the appropriate section of the case report form (eCRF).
Visit 6, or the 'Early termination Visit' will represent the conclusion of patient's participation in the investigation.
- Conditions
- Infection
- Being tested
- Oxygen-ozone therapy
- Keywords
- Infection, Orthopaedic device
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxygen-ozone therapyProcedure or surgery
Oxygen-ozone therapy (group a) will be performed by:
- Self-haemoinfusion of 200 cc. with concentrations of 40-50 μg/ml, to be performed two/three times a week, for a time of 6 weeks (for a maximum of 15 sessions); ii) Subcutaneous injections in the perilesional site at the dose of 5 cc. with concentrations of 4 μg,/ml, Cleanse wounds with 100 cc of 5-10 ug ozone gas
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Oxygen-ozone therapy plus antibiotic therapy Receives: Procedure: Oxygen-ozone therapy |
| Arm B | Other | Antibiotic therapy Receives: Procedure: Oxygen-ozone therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical success at Day 14
Resolution/improvement of signs and symptoms of infection of the wound in the target lesion (i.e. a score ≤ 1 for a maximum of two signs/symptoms) from baseline to Day 14. The following symptoms will be evaluated by patients on a 0-4 point Likert scale (0 = no symptom; 1 = mild symptom; 2 = moderate symptom; 3 = severe symptom; 4 = very severe symptom): pain, burning, redness and malodour.
The following signs will be evaluated by investigators on a 0-4 point Likert scale (0 = no sign; 1 = mild sign; 2 = moderate sign; 3 = severe sign; 4 = very severe sign): erythema, local warmth, swelling, purulent secretion.
Measured: 2 week
Secondary outcomes (9)
Proportion of patients with clinical success at Day 7, Day 28, and Day 42
Clinical success is defined as resolution/improvement of signs and symptoms of infection of the wound in the target lesion
Measured: Day 7, Day 28, and Day 42
Time to resolution of all signs and symptoms of infection
It is defined as the disappearance (score = 0) of all signs and symptoms of infection of the wound in the target lesion;
Measured: 7 weeks
Eradication of the pathogen isolated at the screening visit
Bacteriological success of the wound in the target lesion at Day 14 (V4) and Day 42 (V6).A bacteriological success is defined as eradication of the pathogen isolated at the screening visit, without superinfection or reinfection with the same pathogen;
Measured: 7 weeks
Changes from baseline to any post-baseline time-point of the size of the target lesion
Measured: 7 weeks
Global assessment of the target lesion at Day 14 and Day 42
Investigators will be requested to score the outcome of the target lesion on a five-grade scale: 1= worsening, 2 = no change, 3 = minimal improvement, 4 = moderate improvement and 5 = good improvement/resolution;
Measured: 7 weeks
Changes from baseline to any post-baseline time-point in body temperature
Measured: 7 weeks
Changes in WBCs count
Changes from baseline to Day 14 (V4) and Day 42 (V6) of white blood cells count (a laboratory parameters that is indicative of infection)
Measured: 7 weeks
Changes in Erythrocyte sedimentation rate
Changes from baseline to Day 14 (V4) and Day 42 (V6) of ESR values (a laboratory parameters that is indicative of infection)
Measured: 7 weeks
Changes in High-sensitivity C-reactive protein
Changes from baseline to Day 14 (V4) and Day 42 (V6) of hs-CRP values (a laboratory parameters that is indicative of infection)
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study start24 Jan 2024
- Primary completionSep 2025 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfectionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open-label, multicentre, randomized, parallel group study
- Masking
- None (open label)
- Enrolment
- 186 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Società Scientifica Internazionale di Ossigeno Ozono Terapia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonio Guastafierro, Principal investigator, PINETA GRANDE HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04787575
- Sponsor's protocol ID
- sOO3T1 Study
- Status last verified
- Apr 2024
- First submitted
- 18 Feb 2021
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cascini F, Franzini M, Andreoli A, Manzotti A, Cadeddu C, Quaranta G, Gentili A, Ricciardi W. Use of oxygen-ozone therapy to improve the effectiveness of antibiotic treatment on infected arthroplasty: protocol for a superiority, open-label, multicentre, randomised, parallel trial. BMJ Open. 2024 Jan 4;14(1):e076739. doi: 10.1136/bmjopen-2023-076739.
PubMed 38176866
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Multicentre, Randomized, Parallel Group Study to Assess the Efficacy and Safety of Oxygen-ozone Therapy Plus Oral Antibiotic Therapy in the Treatment of Infections Secondary to Implant of Orthopaedic Devices
- ClinicalTrials.gov ID
- NCT04787575
- Acronym / sponsor ID
- sOO3T1 Study
- Conditions
- Infection
- Keywords
- Infection, Orthopaedic device
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 186 participants (estimated)
- Lead sponsor
- Società Scientifica Internazionale di Ossigeno Ozono TerapiaUniversity, hospital or other
- Study start
- 24 Jan 2024 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 8 Mar 2021 (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.
This is an open-label, multicentre, randomized, parallel group study to evaluate the efficacy of treatment with oxygen-ozone therapy plus oral antibiotic therapy, in comparison with oral antibiotic therapy alone, in the proportion of patients with resolution/improvement of signs and symptoms of infection of the wound (e.g. ulcer, eschar, sore) in the target lesion after 14 days of treatment, in patients with infections secondary to implant of orthopaedic devices.
Detailed description
This will be an open-label, multicentre, randomized, parallel group study. The study plan will include a screening visit (Visit 1, Day -7/-3) in which patients will be screened on the basis of inclusion/exclusion criteria and clinically evaluated.
At the end of the 3-7 days of run-in (Visit 2, Baseline visit, Day 0), patient still eligible will be randomised to one of the two following treatment groups:
- Oxygen-ozone therapy SIOOT plus antibiotic therapy
- Antibiotic therapy
Patients in both groups will receive oral antibiotic therapy, which will be prescribed at discretion of the Investigator, based on the results of the colture of the swab collected in the target lesion at the screening visit (and later, if needed) and the associated antibiogram.
Follow-up visits will be performed after 7 days (Visit 3, Day 7), 14 days (Visit 4, Day 14), 28 days (Visit 5, Day 28) and 42 days (Visit 6, End of study, Day 42) from the start of treatment.
A visit window of ± 2 days for the date of Visits 3-5 and of ± 3 days for the date of Visits 6 will be allowed.
Patients prematurely discontinued from the study will perform an 'Early termination visit', in which procedures schedule for Visit 6 (End of study, Day 42) will be performed. In case of premature study discontinuation, the Investigator will duly record the reason for premature withdrawal in the appropriate section of the case report form (eCRF).
Visit 6, or the 'Early termination Visit' will represent the conclusion of patient's participation in the investigation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open-label, multicentre, randomized, parallel group study
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Procedure: Oxygen-ozone therapyOxygen-ozone therapy plus antibiotic therapy |
| Arm B | Other | Procedure: Oxygen-ozone therapyAntibiotic therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Signed written informed consent;
- Male or female aged ≥ 18 years;
- Patient having undergone surgery for implant of an orthopaedic device in the previous 8 weeks;
- Presence of at least one (but no more than 3) post-operative wounds in the site of surgery (ulcers, eschars, sores);
- Presence of at least one symptom (pain, burning, redness and malodour) and at least one sign (erythema, local warmth, swelling, purulent secretion) of infection of at least moderate intensity (score ≥ 2) in the target lesion at the screening visit (Visit 1), to be confirmed again at the baseline visit (Visit 2);
Key exclusion criteria (17 listed)
- Wounds without signs of localized infection;
- Presence of more than four wounds;
- Presence of one or more wounds with area > 100 cm2;
- Presence of undermining wounds;
- Patients with favism, i.e. deficiency of the glucose-6-phosphate dehydrogenase (G6PD) enzyme;
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 |
|---|---|---|
| Oxygen-ozone therapyOxygen-ozone therapy (group a) will be performed by: i) Self-haemoinfusion of 200 cc. with concentrations of 40-50 μg/ml, to be performed two/three times a week, for a time of 6 weeks (for a maximum of 15 sessions); ii) Subcutaneous injections in the perilesional site at the dose of 5 cc. with concentrations of 4 μg,/ml, Cleanse wounds with 100 cc of 5-10 ug ozone gas | Procedure or surgery | Arm A, Arm B |
Primary outcome
Clinical success at Day 14
Time frame: 2 week
Resolution/improvement of signs and symptoms of infection of the wound in the target lesion (i.e. a score ≤ 1 for a maximum of two signs/symptoms) from baseline to Day 14. The following symptoms will be evaluated by patients on a 0-4 point Likert scale (0 = no symptom; 1 = mild symptom; 2 = moderate symptom; 3 = severe symptom; 4 = very severe symptom): pain, burning, redness and malodour. The following signs will be evaluated by investigators on a 0-4 point Likert scale (0 = no sign; 1 = mild sign; 2 = moderate sign; 3 = severe sign; 4 = very severe sign): erythema, local warmth, swelling, purulent secretion.
9 secondary outcomes
Proportion of patients with clinical success at Day 7, Day 28, and Day 42
Time frame: Day 7, Day 28, and Day 42
Time to resolution of all signs and symptoms of infection
Time frame: 7 weeks
Eradication of the pathogen isolated at the screening visit
Time frame: 7 weeks
Changes from baseline to any post-baseline time-point of the size of the target lesion
Time frame: 7 weeks
Global assessment of the target lesion at Day 14 and Day 42
Time frame: 7 weeks
Changes from baseline to any post-baseline time-point in body temperature
Time frame: 7 weeks
Changes in WBCs count
Time frame: 7 weeks
Changes in Erythrocyte sedimentation rate
Time frame: 7 weeks
Changes in High-sensitivity C-reactive protein
Time frame: 7 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Derived from this study: PubMed 38176866Cascini F, Franzini M, Andreoli A, Manzotti A, Cadeddu C, Quaranta G, Gentili A, Ricciardi W. Use of oxygen-ozone therapy to improve the effectiveness of antibiotic treatment on infected arthroplasty: protocol for a superiority, open-label, multicentre, randomised, parallel trial. BMJ Open. 2024 Jan 4;14(1):e076739. doi: 10.1136/bmjopen-2023-076739.
- Individual participant dataSharing planned: No
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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.
Antonio Guastafierro principal investigator
PINETA GRANDE HOSPITAL
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxygen-ozone therapy in people with Infection, run by Società Scientifica Internazionale di Ossigeno Ozono Terapia at 6 sites in Italy.
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 12 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marianno Franzini (035 19910105, info@ossigenoozono.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical success at Day 14 (time frame: 2 week). 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 NCT04787575, which also lists 1 linked publication.
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 17 Apr 2024.