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New study aims to speed up detection of dangerous hospital bacteria

NCT ID NCT07397416

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether a faster genetic test (PCR) can help hospitals detect a dangerous bacteria called CPE more quickly than the current lab method, which takes up to 48 hours. Researchers will compare how long it takes to start or stop patient isolation using each method in about 800 adults admitted to a hospital in Argentina. The goal is to see if the rapid test can reduce delays and improve infection control without needing to change current practices.

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.

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

May 2026

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: * Adult patients aged ≥18 years * Patients screened for carbapenemase-producing Enterobacterales (CPE) carriage by perianal swab within the first 5 days of hospital admission * Patients newly identified as CPE-colonized, leading to initiation of contact isolation * Patients found to be decolonized, leading to discontinuation of contact isolation * Patients with indication for active surveillance at hospital admission: * Transfer from another healthcare facility * Hospitalization in another healthcare center within the previous month * Patients undergoing active surveillance during hospitalization: * First surveillance swab in high-risk neutropenic patients (HAR flag) * First surveillance swab in immunosuppressed units, such as hematopoietic stem-cell transplant wards * Patients evaluated for discontinuation of contact precautions who meet all of the following: * Prior CPE-positive surveillance sample * At least 3 months since the last positive result and last hospitalization * No systemic antibiotic exposure during that period Exclusion Criteria: * Lost samples * Insufficient samples * Invalid laboratory test results requiring repeat sampling

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Conditions

The condition(s) this trial relates to.

Enterobacteriaceae Infections nosocomial infection

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.

  1. 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 ↗

  2. A doctor treating you

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