Personalized antibiotic strategy aims to prevent deadly infections after kidney transplant
NCT ID NCT07407673
First seen Jun 27, 2026 · Last updated Jul 23, 2026 · Updated 2 times
Summary
This study tests whether giving a daily antibiotic (pivmecillinam) to kidney transplant patients at high risk of bloodstream infections can reduce those infections. 150 participants will receive either the antibiotic or a placebo for 5 months after transplant. The goal is to see if a personalized prevention approach works better than treating everyone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 180 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2027
An estimate. Start dates often move.
- Expected to finish
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Jul 2041
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age ≥18 years. 2. Kidney transplant recipient. 3. Able to provide written informed consent. 4. ≥1 urine sample with bacteriuria ≥10\^5 CFU/mL (excluding fungi) within first month post-transplantation. Exclusion Criteria: 1. Known strictures in the esophagus and/or obstructions in the gastrointestinal tract including diabetes gastroparesis. 2. Known hypersensitivity or allergy to β-lactam antibiotics. 3. Known or suspected genetic metabolism anomalies in the carnitine metabolism, including carnitine transporter defect or organic acidurias such as methylmalonic aciduria or propionic acidaemia. 4. Individuals of Faroese descent (defined as both biological parents born in the Faroe Islands). 5. Porphyria. 6. Current treatment with valproic acid, valproate or other medications liberating pivalic acid. 7. Current treatment with probenecid. 8. Current treatment with methotrexate. 9. Ongoing dialysis one month post-transplantation. 10. Pregnancy or breastfeeding.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Aarhus University Hospital, Department of Nephrology
Aarhus, 8200, Denmark
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Odense University Hospital, Department of Nephrology
Odense, 5000, Denmark
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Rigshospitalet, Department of Nephrology
Copenhagen, 2100, Denmark
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- New fluid aims to keep donated kidneys healthier
- Can a computer model speed up sepsis blood tests?
- Gut bacteria transplant tested against Antibiotic-Resistant urinary infections
- Can a phone app and a coach keep a new kidney healthier?
- Can a simple blood test predict sepsis two days early?
- A new tool aims to predict and prevent living kidney donor Drop-Out