Bone Infection, Fractures, Bone, Infection, Bacterial, Joint Infection
Conditions
Keywords
Gut Microbiome, Joint Infection, Bone Infection, Antibiotic Therapy
Brief 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. 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.
Interventions
no intervention, observational only
Sponsors
AO Research Institute Davos
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* The patient is planned to undergo revision surgery due to suspected bone or joint infection. * The patient is at least 18 years old
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composition of the the gut microbiota following two weeks of intravenous antibiotic therapy | 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 24 weeks after antibiotic therapy start | 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. |
| Composition of the gut microbiota following four weeks of oral antibiotic therapy | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Monitoring Rifampicin resistant S. aureus on the skin following two weeks of iv antibiotic therapy | Two weeks | 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. |
| Monitoring Rifampicin resistant S. aureus on the skin following four weeks of oral antibiotic therapy | Six weeks (including two weeks iv and 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. |
| Monitoring Rifampicin resistant S. aureus on the skin 24 weeks after antibiotic therapy start | 24 weeks | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Level of systemic Inflammation following two weeks of iv antibiotic therapy | Two weeks | Inflammatory cytokines in the blood will be measured and compared to baseline samples of the patients. |
| Level of systemic Inflammation 24 weeks after antibiotic therapy start | 24 weeks | Inflammatory cytokines in the blood will be measured and compared to baseline samples of the patients. |
| Level of systemic Inflammation following four weeks of oral antibiotic therapy | Six weeks (including two weeks iv and four weeks of oral antibiotic therapy) | Inflammatory cytokines in the blood will be measured and compared to baseline samples of the patients. |
| Monitoring mucosal immune response following two weeks of iv antibiotic therapy | Two weeks | IgA levels will measured in saliva of the patients and compared to baseline samples of the patients. |
| Monitoring mucosal immune response following four weeks of oral antibiotic therapy | Six weeks (including two weeks iv and four weeks of oral antibiotic therapy) | IgA levels will measured in saliva of the patients and compared to baseline samples of the patients. |
| Monitoring mucosal immune response 24 weeks after antibiotic therapy start | 24 weeks | IgA levels will measured in saliva of the patients and compared to baseline samples of the patients. |
Countries
Switzerland
Outcome results
None listed