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

NCT04440631 | Completed

• 1 other identifier: Microbiome
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 2

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.

Conditions

Fractures, Bone; Infection, Bacterial; Joint Infection; Bone Infection

Keywords

Gut Microbiome; Joint Infection; Bone Infection; Antibiotic Therapy

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  24 weeks

Secondary Outcomes (3)

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

  Two weeks

• 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)

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

  24 weeks

Other Outcomes (6)

• Level of systemic Inflammation following two weeks of iv antibiotic therapy

  Two weeks

• Level of systemic Inflammation following four weeks of oral antibiotic therapy

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

• Level of systemic Inflammation 24 weeks after antibiotic therapy start

  24 weeks

Study Arms (3)

Antibiotic therapy including rifampicin

Other: no intervention, observational only

Non-rifampicin antibiotic therapy

Other: no intervention, observational only

Control group (healthy volunteers)

Other: no intervention, observational only

Interventions

no intervention, observational only OTHER

no intervention, observational only

Antibiotic therapy including rifampicin; Control group (healthy volunteers); Non-rifampicin antibiotic therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The project population will include patients suffering from an ODRI (orthopedic device-related infection). This includes any patient with a bone infection with a current or previous involvement of an implant. The majority of patients are expected to be prosthetic joint infection (PJI) and fracture-related infection (FRI) patients, although also patients with spinal implantation with an infection, or patients who have had an implant removed yet develop an osteomyelitis will also be included. These patients all have a deep bone implant infection and will receive antibiotic therapy, including at least two weeks IV therapy and at least 4 weeks of oral rifampicin. The investigators expect the distribution of patients getting rifampicin or non-rifampicin to be approximately 50/50 overall and anticipate PJI patients will be older, receive more concomitant medications and have underlying co-morbidities than patients with an FRI.

You may qualify if:

• The patient is planned to undergo revision surgery due to suspected bone or joint infection.
• The patient is at least 18 years old

You may not qualify if:

• 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.

Sponsors & Collaborators

• AO Research Institute Davos: lead

Study Sites (2)

Universitätsspital Basel

Basel, 4031, Switzerland

Location

Schulthess Klinik Zürich

Zurich, 8008, Switzerland

Location

MeSH Terms

Conditions

Fractures, Bone; Bacterial Infections

Condition Hierarchy (Ancestors)

Wounds and Injuries; Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2020
• First Posted: June 19, 2020
• Study Start: November 1, 2019
• Primary Completion: June 1, 2022
• Study Completion: December 31, 2022
• Last Updated: February 3, 2023

Record last verified: 2023-02

Locations

CH (2)