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Can a daily antibiotic shield dialysis patients from deadly infections?

NCT ID NCT05248620

Prevention Sponsor: Zealand University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 10, 2026 · Last updated Sep 11, 2026 · Updated 1 time

Summary

People with end-stage kidney disease who start hemodialysis often use a central venous catheter for access. These catheters raise the risk of bloodstream infections. Researchers are testing whether a daily antibiotic, amoxicillin-clavulanic acid, can prevent these infections compared with a placebo. The trial enrolls 800 adults on hemodialysis and tracks hospitalizations for bloodstream infections and severe culture-negative infections.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
amoxicillin-clavulanic acid, an antibiotic combination
What this could lead to
If it works, this could offer a simple way to protect dialysis patients with catheters from dangerous bloodstream infections.
What could go wrong
Antibiotics can cause side effects and may not prevent all infections. Overuse could also lead to resistant bacteria, and the trial may not show a clear benefit.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 800 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2022

Expected to finish

May 2029

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * End Stage Kidney Disease (ESKD) patients who receive an uncuffed or cuffed CVC for expected chronic HD, regardless of previous ESKD treatment modality (PD or KTX) and hemodialysis access (AV-fistula or AV-graft)) * ≥18 years * Ability to understand the study background, risk and benefit of treatment and to give written informed consent Exclusion Criteria: * Unable to give informed consent * Known intolerance to beta-lactam antibiotics and clindamycin * Active infection treated with antibiotics * Breastfeeding * Pregnancy. In women of childbearing age, an approved birth control must be ensured at least 1 month before and during all the 6 months of antibiotic/placebo treatment. Patients may be rescreened later i.e. within a time period of one month from start of HD, if exclusion criteria are reversible.

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Conditions

The condition(s) this trial relates to.

end stage renal failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hemodialysis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    7 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Aalborg University Hospital

    RECRUITING

    Aalborg, North Region, 9100, Denmark

  • Aarhus University Hospital

    NOT_YET_RECRUITING

    Aarhus, Middle Region, 8200, Denmark

  • Herlev-Gentofte Hospital

    RECRUITING

    Copenhagen, Capital Region, 2730, Denmark

  • North Zealand Hospital Hillerød

    NOT_YET_RECRUITING

    Hillerød, Capital Region, 3400, Denmark

  • Odense University Hospital

    RECRUITING

    Odense, Region South, 5000, Denmark

  • Rigshospitalet

    NOT_YET_RECRUITING

    Copenhagen, Capital Region, 2100, Denmark

  • ZUH Roskilde

    RECRUITING

    Roskilde, Region Sjælland, 4000, Denmark

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