Decolonization of Gram-negative Multi-resistant Organisms (MDRO) with Donor Microbiota (FMT)
Recruiting
Phase 2
Phase 3
Interventional Study
Resistance Bacterial
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2/3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 150 (estimated)
- Sponsor
- University Hospital, Ghent · Other
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About This Trial
Colonization by Multiple Drug Resistant Organisms (MDROs) during patient hospitalization requires expensive isolation measures and renders the return or transfer to other departments or institutions often impossible. Currently there is no specific treatment available. Patients have to wait for spontaneous clearance which can take months or does not happen at all.
The study will test the effect of…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Participants must be at least 18 years of age, and must sign the 'informed consent' form and thus agree with the data collection, sampling and FMT.
* At least 2 consecutive confirmations of MDRO colonization in faeces, which complicate the necessary follow-up and/or therapy fo…
Contacts