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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Antibiotic therapy including rifampicin |
| ||
| Non-rifampicin antibiotic therapy |
| ||
| Control group (healthy volunteers) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| no intervention, observational only | Other | no intervention, observational only |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Two weeks |
| Monitoring Rifampicin resistant S. aureus on the skin following four weeks of oral antibiotic therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Level of systemic Inflammation following two weeks of iv antibiotic therapy | Inflammatory cytokines in the blood will be measured and compared to baseline samples of the patients. | Two weeks |
| Level of systemic Inflammation following four weeks of oral antibiotic therapy |
Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsspital Basel | Basel | 4031 | Switzerland | |||
| Schulthess Klinik Zürich |
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| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D001424 | Bacterial Infections |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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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. |
| 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. | 24 weeks |
Inflammatory cytokines in the blood will be measured and compared to baseline samples of the patients. |
| Six weeks (including two weeks iv and four weeks of oral antibiotic therapy) |
| Level of systemic Inflammation 24 weeks after antibiotic therapy start | Inflammatory cytokines in the blood will be measured and compared to baseline samples of the patients. | 24 weeks |
| Monitoring mucosal immune response following two weeks of iv antibiotic therapy | IgA levels will measured in saliva of the patients and compared to baseline samples of the patients. | Two weeks |
| Monitoring mucosal immune response following four weeks of oral antibiotic therapy | IgA levels will measured in saliva of the patients and compared to baseline samples of the patients. | Six weeks (including two weeks iv and four weeks of oral antibiotic therapy) |
| Monitoring mucosal immune response 24 weeks after antibiotic therapy start | IgA levels will measured in saliva of the patients and compared to baseline samples of the patients. | 24 weeks |
| Zurich |
| 8008 |
| Switzerland |