Fractures, BoneIMPAT-ODRINCT04440631
Gut Microbiome of Patients Undergoing Antibiotic Therapy for Orthopedic Device-related Infection
An observational study of Fractures, Bone and Infection, Bacterial, run by AO Research Institute Davos at 2 sites in Switzerland.
Trial summary
The microbiome of 80 orthopedic-device related infection (ODRI) patients treated with antibiotics and 10 healthy controls will be investigated. Samples (blood, stool, saliva, skin-swab) are collected 4x within 6 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fractures, Bone, Infection, Bacterial, Joint Infection
- How many people
- 12 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 1 Nov 2019to 31 Dec 2022
- Phase
- Observational
- 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
- Adult, Older adult
Study population: The project population will include patients suffering from an ODRI (orthopedic device-related infection). This includes any patient with a bone infection with a current or previous involvement of an implant. The majority of patients are expected to be prosthetic joint infection (PJI) and fracture-related infection (FRI) patients, although also patients with spinal implantation with an infection, or patients who have had an implant removed yet develop an osteomyelitis will also be included. These patients all have a deep bone implant infection and will receive antibiotic therapy, including at least two weeks IV therapy and at least 4 weeks of oral rifampicin. The investigators expect the distribution of patients getting rifampicin or non-rifampicin to be approximately 50/50 overall and anticipate PJI patients will be older, receive more concomitant medications and have underlying co-morbidities than patients with an FRI.
Who may be able to join
- The patient is planned to undergo revision surgery due to suspected bone or joint infection.
- The patient is at least 18 years old
Who cannot join
- The patient took antibiotics in the previous six weeks of recruitment (a single dose/"shot" of antibiotics during this period is not considered).
- The patient suffers from gut-associated morbidities such as Morbus Crohn or colitis ulcerosa.
- The patient suffers from psychiatric disorders/cognitive impairment affecting understanding.
- The patient is unable to give consent and follow procedures and/or has insufficient knowledge of the project language.
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Universitätsspital Basel
Basel, 4031
Schulthess Klinik Zürich
Zurich, 8008
About this study
Official title: Investigation of the Microbiome of Patients Receiving Antibiotic Therapy for Orthopedic Device-related Infection
The microbiome of 80 orthopedic-device related infection (ODRI) patients treated with antibiotics and 10 healthy controls will be investigated. Samples (blood, stool, saliva, skin-swab) are collected 4x within 6 months. Composition and diversity of the microbiome will be assessed by 16sRNA sequencing, skins swabs are screened for rifampicin-resistant staphylococci onto Mannitol-salt-agar plates supplemented with rifampicin, inflammation markers and antibodies in blood and saliva are monitored to track changes in the immune response. For further analysis patients are assigned to one of two groups: 1) antibiotic therapy including rifampicin and 2) non-rifampicin antibiotic therapy.
- Conditions
- Fractures, Bone, Infection, Bacterial, Joint Infection, Bone Infection
- Being tested
- no intervention, observational only
- Keywords
- Gut Microbiome, Joint Infection, Bone Infection, Antibiotic Therapy
- Medical subject headings
- Fractures, Bone, Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no intervention, observational onlyOther
no intervention, observational only
| Study group | Role | What they receive |
|---|---|---|
| Antibiotic therapy including rifampicin | Not described Receives: Other: no intervention, observational only | |
| Non-rifampicin antibiotic therapy | Not described Receives: Other: no intervention, observational only | |
| Control group (healthy volunteers) | Not described Receives: Other: no intervention, observational only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composition of the the gut microbiota following two weeks of intravenous antibiotic therapy
The gut microbiota will be characterized by means of 16s rRNA sequencing. The gut microbiota composition following two weeks of intravenous (iv) antibiotic treatment will be compared to baseline samples of the patients.
Measured: Two weeks
Composition of the gut microbiota following four weeks of oral antibiotic therapy
The gut microbiota will be characterized by means of 16s rRNA sequencing. The gut microbiota composition following four weeks of oral antibiotic treatment will be compared to baseline samples of the patients.
Measured: Six weeks (including two weeks iv and four weeks of oral antibiotic therapy)
Composition of the gut microbiota 24 weeks after antibiotic therapy start
The gut microbiota will be characterized by means of 16s rRNA sequencing. The gut microbiota composition 24 weeks after antibiotic therapy start, including an at least 6-week antibiotic free period, will be compared to baseline samples of the patients.
Measured: 24 weeks
Secondary outcomes (3)
Monitoring Rifampicin resistant S. aureus on the skin following two weeks of iv antibiotic therapy
Skin and nose swabs will be plated on (rifampicin supplemented ) Mannitol-Salt-Agar plates and colonies will be compared to baseline samples of the patients.
Measured: Two weeks
Monitoring Rifampicin resistant S. aureus on the skin following four weeks of oral antibiotic therapy
Skin and nose swabs will be plated on (rifampicin supplemented ) Mannitol-Salt-Agar plates and colonies will be compared to baseline samples of the patients.
Measured: Six weeks (including two weeks iv and four weeks of oral antibiotic therapy)
Monitoring Rifampicin resistant S. aureus on the skin 24 weeks after antibiotic therapy start
Skin and nose swabs will be plated on (rifampicin supplemented ) Mannitol-Salt-Agar plates and colonies will be compared to baseline samples of the patients.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2020
- Study start1 Nov 2019
- Primary completion1 Jun 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fractures, BoneStudies 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
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- AO Research Institute Davos
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04440631
- Sponsor's protocol ID
- Microbiome
- Acronym
- IMPAT-ODRI
- Status last verified
- Feb 2023
- First submitted
- 14 May 2020
- Last updated
- 3 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Microbiome of Patients Receiving Antibiotic Therapy for Orthopedic Device-related Infection
- ClinicalTrials.gov ID
- NCT04440631
- Acronym / sponsor ID
- IMPAT-ODRI / Microbiome
- Conditions
- Fractures, Bone, Infection, Bacterial, Joint Infection, Bone Infection
- Keywords
- Gut Microbiome, Joint Infection, Bone Infection, Antibiotic Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- AO Research Institute DavosUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 19 Jun 2020 (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.
The microbiome of 80 orthopedic-device related infection (ODRI) patients treated with antibiotics and 10 healthy controls will be investigated. Samples (blood, stool, saliva, skin-swab) are collected 4x within 6 months. Composition and diversity of the microbiome will be assessed by 16sRNA sequencing, skins swabs are screened for rifampicin-resistant staphylococci onto Mannitol-salt-agar plates supplemented with rifampicin, inflammation markers and antibodies in blood and saliva are monitored to track changes in the immune response. For further analysis patients are assigned to one of two groups: 1) antibiotic therapy including rifampicin and 2) non-rifampicin antibiotic therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Antibiotic therapy including rifampicin | – | Other: no intervention, observational only |
| Non-rifampicin antibiotic therapy | – | Other: no intervention, observational only |
| Control group (healthy volunteers) | – | Other: no intervention, observational only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The project population will include patients suffering from an ODRI (orthopedic device-related infection). This includes any patient with a bone infection with a current or previous involvement of an implant. The majority of patients are expected to be prosthetic joint infection (PJI) and fracture-related infection (FRI) patients, although also patients with spinal implantation with an infection, or patients who have had an implant removed yet develop an osteomyelitis will also be included. These patients all have a deep bone implant infection and will receive antibiotic therapy, including at least two weeks IV therapy and at least 4 weeks of oral rifampicin. The investigators expect the distribution of patients getting rifampicin or non-rifampicin to be approximately 50/50 overall and anticipate PJI patients will be older, receive more concomitant medications and have underlying co-morbidities than patients with an FRI.
Key inclusion criteria (2 listed)
- The patient is planned to undergo revision surgery due to suspected bone or joint infection.
- The patient is at least 18 years old
Key exclusion criteria (4 listed)
- The patient took antibiotics in the previous six weeks of recruitment (a single dose/"shot" of antibiotics during this period is not considered).
- The patient suffers from gut-associated morbidities such as Morbus Crohn or colitis ulcerosa.
- The patient suffers from psychiatric disorders/cognitive impairment affecting understanding.
- The patient is unable to give consent and follow procedures and/or has insufficient knowledge of the project language.
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 |
|---|---|---|
| no intervention, observational onlyno intervention, observational only | Other | Antibiotic therapy including rifampicin, Control group (healthy volunteers), Non-rifampicin antibiotic therapy |
Primary outcome
Composition of the the gut microbiota following two weeks of intravenous antibiotic therapy
Time frame: Two weeks
The gut microbiota will be characterized by means of 16s rRNA sequencing. The gut microbiota composition following two weeks of intravenous (iv) antibiotic treatment will be compared to baseline samples of the patients.
Composition of the gut microbiota following four weeks of oral antibiotic therapy
Time frame: Six weeks (including two weeks iv and four weeks of oral antibiotic therapy)
The gut microbiota will be characterized by means of 16s rRNA sequencing. The gut microbiota composition following four weeks of oral antibiotic treatment will be compared to baseline samples of the patients.
Composition of the gut microbiota 24 weeks after antibiotic therapy start
Time frame: 24 weeks
The gut microbiota will be characterized by means of 16s rRNA sequencing. The gut microbiota composition 24 weeks after antibiotic therapy start, including an at least 6-week antibiotic free period, will be compared to baseline samples of the patients.
3 secondary outcomes
Monitoring Rifampicin resistant S. aureus on the skin following two weeks of iv antibiotic therapy
Time frame: Two weeks
Monitoring Rifampicin resistant S. aureus on the skin following four weeks of oral antibiotic therapy
Time frame: Six weeks (including two weeks iv and four weeks of oral antibiotic therapy)
Monitoring Rifampicin resistant S. aureus on the skin 24 weeks after antibiotic therapy start
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2023.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fractures, Bone and Infection, Bacterial, run by AO Research Institute Davos at 2 sites in Switzerland.
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 2 inclusion and 4 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: finished, as of the sponsor's last update on 3 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composition of the the gut microbiota following two weeks of intravenous antibiotic therapy (time frame: Two weeks). The study lists 3 primary outcomes in all. 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 3 Feb 2023.