OsteomyelitisNCT07056881
Monotherapy vs Combination Therapy for Bone Infections Caused by Pseudomonas Aeruginosa
An observational study of Osteomyelitis and Pseudomonas Infections, run by Centre Hospitalier de Saint-Denis at 1 site in France.
Trial summary
This study looks at how well one antibiotic (monotherapy) works compared to two antibiotics (combination therapy) in treating bone infections caused by Pseudomonas aeruginosa. It includes 300 adult patients who had this type of infection confirmed by lab tests and medical imaging. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteomyelitis, Pseudomonas Infections, Pseudomonas Aeruginosa
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 11 Apr 2025to 15 Apr 2026
- 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
- Adult, Older adult
Study population: Participants will be selected from the electronic health records of adult patients hospitalized within the AP-HP (Assistance Publique-Hôpitaux de Paris) network. The study population includes individuals diagnosed with osteitis or osteomyelitis who have a confirmed microbiological diagnosis of Pseudomonas aeruginosa infection, along with imaging consistent with bone infection.
Who may be able to join
- Adult patients (≥18 years old)
- Diagnosis of osteitis or osteomyelitis due to Pseudomonas aeruginosa
- Isolation of Pseudomonas aeruginosa from at least one deep, sterile sample (e.g., bone biopsy, joint aspiration)
- Imaging findings consistent with osteomyelitis (MRI, CT scan, or X-ray)
Who cannot join
- No isolation of Pseudomonas aeruginosa
- No imaging evidence suggestive of osteomyelitis
- Patients under 18 years of age
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier de Saint-Denis
Saint-Denis, France
Raphaël PODOLAK, 0142356208, coordination.rechercheclinique@ghtpdfr.fr
About this study
This study looks at how well one antibiotic (monotherapy) works compared to two antibiotics (combination therapy) in treating bone infections caused by Pseudomonas aeruginosa. It includes 300 adult patients who had this type of infection confirmed by lab tests and medical imaging. The goal is to find out if using just one antibiotic is as effective as using two, while also looking at side effects, the need for more surgery, antibiotic resistance, and overall antibiotic use.
- Medical subject headings
- Osteomyelitis, Pseudomonas Infections, Bacterial Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical cure rate at the end of antibiotic treatment, defined as resolution of signs and symptoms of infection without need for additional antibiotic therapy or surgical intervention.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2025
- Study start11 Apr 2025
- Primary completion15 Apr 2026 (estimated)
- Study completion15 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteomyelitisStudies 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
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Saint-Denis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07056881
- Sponsor's protocol ID
- 0108_REANIMATION_OPERA
- Status last verified
- Jun 2025
- First submitted
- 30 Jun 2025
- Last updated
- 9 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monotherapy vs Combination Therapy for Bone Infections Caused by Pseudomonas Aeruginosa
- ClinicalTrials.gov ID
- NCT07056881
- Acronym / sponsor ID
- 0108_REANIMATION_OPERA
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Centre Hospitalier de Saint-DenisUniversity, hospital or other
- Study start
- 11 Apr 2025 (actual)
- Primary completion
- 15 Apr 2026 (estimated)
- Study completion
- 15 Apr 2026 (estimated)
- First posted
- 9 Jul 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.
This study looks at how well one antibiotic (monotherapy) works compared to two antibiotics (combination therapy) in treating bone infections caused by Pseudomonas aeruginosa. It includes 300 adult patients who had this type of infection confirmed by lab tests and medical imaging. The goal is to find out if using just one antibiotic is as effective as using two, while also looking at side effects, the need for more surgery, antibiotic resistance, and overall antibiotic use.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Participants will be selected from the electronic health records of adult patients hospitalized within the AP-HP (Assistance Publique-Hôpitaux de Paris) network. The study population includes individuals diagnosed with osteitis or osteomyelitis who have a confirmed microbiological diagnosis of Pseudomonas aeruginosa infection, along with imaging consistent with bone infection.
Key inclusion criteria (4 listed)
- Adult patients (≥18 years old)
- Diagnosis of osteitis or osteomyelitis due to Pseudomonas aeruginosa
- Isolation of Pseudomonas aeruginosa from at least one deep, sterile sample (e.g., bone biopsy, joint aspiration)
- Imaging findings consistent with osteomyelitis (MRI, CT scan, or X-ray)
Key exclusion criteria (3 listed)
- No isolation of Pseudomonas aeruginosa
- No imaging evidence suggestive of osteomyelitis
- Patients under 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical cure rate at the end of antibiotic treatment, defined as resolution of signs and symptoms of infection without need for additional antibiotic therapy or surgical intervention.
Time frame: 6 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 9 Jul 2025.
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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.
Centre Hospitalier de Saint-Denis
Saint-Denis, France
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 Osteomyelitis and Pseudomonas Infections, run by Centre Hospitalier de Saint-Denis at 1 site in France.
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 3 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: looking for participants now, as of the sponsor's last update on 9 Jul 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 France. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical cure rate at the end of antibiotic treatment, defined as resolution of signs and symptoms of infection without need for additional antibiotic therapy or surgical intervention. (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jul 2025.