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Gut Microbiome of Patients Undergoing Antibiotic Therapy for Orthopedic Device-related Infection (IMPAT-ODRI)

A

AO Research Institute Davos

Status

Completed

Conditions

Joint Infection
Fractures, Bone
Infection, Bacterial
Bone Infection

Treatments

Other: no intervention, observational only

Study type

Observational

Funder types

Other

Identifiers

NCT04440631
Microbiome

Details and patient eligibility

About

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.

Enrollment

12 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

12 participants in 3 patient groups

Antibiotic therapy including rifampicin
Treatment:
Other: no intervention, observational only
Non-rifampicin antibiotic therapy
Treatment:
Other: no intervention, observational only
Control group (healthy volunteers)
Treatment:
Other: no intervention, observational only

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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