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

Fractures, Bone Clinical Trial

— IMPAT-ODRI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04440631
• Other study ID #: Microbiome
• Status: Completed
• Start date: November 1, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2023
• Source: AO Research Institute Davos
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 31, 2022
• Est. primary completion date: June 1, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bacterial Infections
• Bone Infection
• Communicable Diseases
• Fractures, Bone
• Infection, Bacterial
• Infections
• Joint Infection
• Prosthesis-Related Infections

Intervention

Other:
• no intervention, observational only
no intervention, observational only

Locations

Country	Name	City	State
Switzerland	Universitätsspital Basel	Basel
Switzerland	Schulthess Klinik Zürich	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
AO Research Institute Davos

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Level of systemic Inflammation following two weeks of iv antibiotic therapy	Inflammatory cytokines in the blood will be measured and compared to baseline samples of the patients.	Two weeks
Other	Level of systemic Inflammation following four weeks of oral antibiotic therapy	Inflammatory cytokines in the blood will be measured and compared to baseline samples of the patients.	Six weeks (including two weeks iv and four weeks of oral antibiotic therapy)
Other	Level of systemic Inflammation 24 weeks after antibiotic therapy start	Inflammatory cytokines in the blood will be measured and compared to baseline samples of the patients.	24 weeks
Other	Monitoring mucosal immune response following two weeks of iv antibiotic therapy	IgA levels will measured in saliva of the patients and compared to baseline samples of the patients.	Two weeks
Other	Monitoring mucosal immune response following four weeks of oral antibiotic therapy	IgA levels will measured in saliva of the patients and compared to baseline samples of the patients.	Six weeks (including two weeks iv and four weeks of oral antibiotic therapy)
Other	Monitoring mucosal immune response 24 weeks after antibiotic therapy start	IgA levels will measured in saliva of the patients and compared to baseline samples of the patients.	24 weeks
Primary	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
Primary	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)
Primary	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	Monitoring Rifampicin resistant S. aureus on the skin following two weeks of iv 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.	Two weeks
Secondary	Monitoring Rifampicin resistant S. aureus on the skin following 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.	Six weeks (including two weeks iv and four weeks of oral antibiotic therapy)
Secondary	Monitoring Rifampicin resistant S. aureus on the skin 24 weeks after antibiotic therapy start	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.	24 weeks