Gut Microbiome of Patients Undergoing Antibiotic Therapy for Orthopedic Device-related Infection (NCT04440631) | Clinical Trial Compass
CompletedNot Applicable
Gut Microbiome of Patients Undergoing Antibiotic Therapy for Orthopedic Device-related Infection
Switzerland12 participantsStarted 2019-11-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Composition of the the gut microbiota following two weeks of intravenous antibiotic therapy
Timeframe: Two weeks
2
Composition of the gut microbiota following four weeks of oral antibiotic therapy
Timeframe: Six weeks (including two weeks iv and four weeks of oral antibiotic therapy)
3
Composition of the gut microbiota 24 weeks after antibiotic therapy start