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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04440631
Other study ID # Microbiome
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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.

Study Design


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
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