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

NCT ID: NCT04440631

Last Updated: 2023-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-01

Study Completion Date

2022-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Fractures, Bone Infection, Bacterial Joint Infection Bone Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Antibiotic therapy including rifampicin

no intervention, observational only

Intervention Type OTHER

no intervention, observational only

Non-rifampicin antibiotic therapy

no intervention, observational only

Intervention Type OTHER

no intervention, observational only

Control group (healthy volunteers)

no intervention, observational only

Intervention Type OTHER

no intervention, observational only

Interventions

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no intervention, observational only

no intervention, observational only

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AO Research Institute Davos

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Universitätsspital Basel

Basel, , Switzerland

Site Status

Schulthess Klinik Zürich

Zurich, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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Microbiome

Identifier Type: -

Identifier Source: org_study_id

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