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

Completed

• Conditions: Fractures, Bone; Joint Infection; Infection, Bacterial; Bone Infection
• Interventions: Other: no intervention, observational only

• Registration Number: NCT04440631
• Lead Sponsor: AO Research Institute Davos

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-01
• Study First Submitted: 2020-05-14
• Study First Submitted QC: 2020-06-18
• Study First Posted: 2020-06-19
• Primary Completion: 2022-06-01
• Study Completion: 2022-12-31
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-02
• Last Update Posted: 2023-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-rifampicin antibiotic therapy	no intervention, observational only	-
Antibiotic therapy including rifampicin	no intervention, observational only	-
Control group (healthy volunteers)	no intervention, observational only	-

Primary Outcome Measures

Name	Time	Method
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 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.
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.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

Universitätsspital Basel; 🇨🇭 Basel, Switzerland

Schulthess Klinik Zürich; 🇨🇭 Zürich, Switzerland