Gut Microbiome of Patients Undergoing Antibiotic Therapy for Orthopedic Device-related Infection

AO Research Institute Davos12 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Fractures, Bone Infection, Bacterial Joint Infection Bone Infection

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (2)

Universitätsspital Basel

Basel, Switzerland

Schulthess Klinik Zürich

Zurich, Switzerland

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 24 weeks

Secondary Outcomes

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.

Time frame: 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.

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

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.

Time frame: 24 weeks