Clinical trial NCT04440631: Gut Microbiome of Patients Undergoing Antibiotic Therapy for Orthopedic Device-related Infection
Official title: Investigation of the Microbiome of Patients Receiving Antibiotic Therapy for Orthopedic Device-related Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fractures, Bone
Infection, Bacterial
Joint Infection
Bone Infection
Keywords: Gut Microbiome
Joint Infection
Bone Infection
Antibiotic Therapy
Lead sponsor: AO Research Institute Davos
Sponsor class: OTHER
First posted: 2020-06-19
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Composition of the the gut microbiota following two weeks of intravenous antibiotic therapy
timeFrame: Two weeks
measure: Composition of the gut microbiota following four weeks of oral antibiotic therapy
timeFrame: Six weeks (including two weeks iv and four weeks of oral antibiotic therapy)
measure: Composition of the gut microbiota 24 weeks after antibiotic therapy start
timeFrame: 24 weeks
Secondary outcomes:
measure: Monitoring Rifampicin resistant S. aureus on the skin following two weeks of iv antibiotic therapy
timeFrame: Two weeks
measure: Monitoring Rifampicin resistant S. aureus on the skin following four weeks of oral antibiotic therapy
timeFrame: Six weeks (including two weeks iv and four weeks of oral antibiotic therapy)
measure: Monitoring Rifampicin resistant S. aureus on the skin 24 weeks after antibiotic therapy start
timeFrame: 24 weeks
Other outcomes:
measure: Level of systemic Inflammation following two weeks of iv antibiotic therapy
timeFrame: Two weeks
measure: Level of systemic Inflammation following four weeks of oral antibiotic therapy
timeFrame: Six weeks (including two weeks iv and four weeks of oral antibiotic therapy)
measure: Level of systemic Inflammation 24 weeks after antibiotic therapy start
timeFrame: 24 weeks
measure: Monitoring mucosal immune response following two weeks of iv antibiotic therapy
timeFrame: Two weeks
measure: Monitoring mucosal immune response following four weeks of oral antibiotic therapy
timeFrame: Six weeks (including two weeks iv and four weeks of oral antibiotic therapy)
measure: Monitoring mucosal immune response 24 weeks after antibiotic therapy start
timeFrame: 24 weeks
Locations:
city: Basel
country: Switzerland
facility: Universitätsspital Basel
city: Zürich
country: Switzerland
facility: Schulthess Klinik Zürich
Study officials:
References: