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NCT Number: NCT04440631

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

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.

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Key information

Conditions

Fractures, Bone Bacterial Infections Bacterial Infections and Mycoses Bone Infection Infection, Bacterial Infections Joint Infection Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitätsspital Basel, Basel, Switzerland

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Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

no intervention, observational only

Other

no intervention, observational only

Primary outcomes

  1. Composition of the the gut microbiota following two weeks of intravenous antibiotic therapy

    Time frame: 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.

  2. Composition of the gut microbiota following four weeks of oral antibiotic therapy

    Time frame: 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.

  3. Composition of the gut microbiota 24 weeks after antibiotic therapy start

    Time frame: 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 outcomes

  1. Monitoring Rifampicin resistant S. aureus on the skin following two weeks of iv antibiotic therapy

    Time frame: 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.

  2. Monitoring Rifampicin resistant S. aureus on the skin following four weeks of oral antibiotic therapy

    Time frame: 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.

  3. Monitoring Rifampicin resistant S. aureus on the skin 24 weeks after antibiotic therapy start

    Time frame: 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.

Other outcomes

  1. Level of systemic Inflammation following two weeks of iv antibiotic therapy

    Time frame: Two weeks

    Inflammatory cytokines in the blood will be measured and compared to baseline samples of the patients.

  2. Level of systemic Inflammation following four weeks of oral antibiotic therapy

    Time frame: Six weeks (including two weeks iv and four weeks of oral antibiotic therapy)

    Inflammatory cytokines in the blood will be measured and compared to baseline samples of the patients.

  3. Level of systemic Inflammation 24 weeks after antibiotic therapy start

    Time frame: 24 weeks

    Inflammatory cytokines in the blood will be measured and compared to baseline samples of the patients.

  4. Monitoring mucosal immune response following two weeks of iv antibiotic therapy

    Time frame: Two weeks

    IgA levels will measured in saliva of the patients and compared to baseline samples of the patients.

  5. Monitoring mucosal immune response following four weeks of oral antibiotic therapy

    Time frame: Six weeks (including two weeks iv and four weeks of oral antibiotic therapy)

    IgA levels will measured in saliva of the patients and compared to baseline samples of the patients.

  6. Monitoring mucosal immune response 24 weeks after antibiotic therapy start

    Time frame: 24 weeks

    IgA levels will measured in saliva of the patients and compared to baseline samples of the patients.

Sponsors and collaborators

Lead sponsor

AO Research Institute Davos

Other

Registry information

Official study title

Investigation of the Microbiome of Patients Receiving Antibiotic Therapy for Orthopedic Device-related Infection

Acronym: IMPAT-ODRI

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jun 19, 2020
Registry last updated
Feb 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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