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New antibiotic shows promise against superbug blood infections

NCT ID NCT04478721

Disease control Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla Source: ClinicalTrials.gov ↗

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested whether an older antibiotic, temocillin, works as well as the standard treatment meropenem for bloodstream infections caused by drug-resistant bacteria. 334 adults with these infections were randomly assigned to receive one of the two antibiotics for 7 to 14 days. The main goal was to see if temocillin could successfully treat the infection without patients needing to switch drugs or have symptoms return.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

334 people

The number who actually took part.

Started

Dec 2020

Finished

Dec 2024

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 with monomicrobial bacteremia due to Enterobacteriaceae showing resistance to cefotaxime, ceftriaxone (MIC \>2 mg/L) and/or ceftazidime (MIC \>4 mg/L), and sensible to temocillin (MIC ≤8 mg/L, except in bacteremia only of urinary origin, for which the criterion is MIC ≤16 mg/L ) and meropenem (MIC ≤2 mg/L). Patients with polymicrobial bacteremia caused by more than one Enterobacteriaceae species may also be included, provided at least one of them is resistant to third-generation cephalosporins, and both are susceptible to meropenem and temocillin. * Duration of intravenous treatment is planned to be at least 4 days from randomization, or 3 days if the empirical treatment prior to randomization was active. * The patient signed informed consent form. * Potentially fertile patients must have a negative pregnancy test. Exclusion Criteria: * \<18 years * Pregnancy * Breastfeeding * Terminal condition, with life expectancy of less than 30 days, or palliative care , such that no actions will be taken to control the source of infection if necessary. Patients receiving palliative care with a life expectancy greater than 30 days may be included if source control is not necessary or, if necessary, will be carried out. * Allergy to betalactams * Polymicrobial bacteraemia (except when the other microorganism is considered a contaminant, (e.g. coagulase-negative staphylococci or diphtheroids in a single blood culture, or in cases where more than one Enterobacteriaceae species is isolated, provided that at least one isolate is resistant to third-generation cephalosporins and both are susceptible to meropenem and temocillin). * Infections typically needing prolonged \>14 days of therapy (e.g., endocarditis, prosthetic joint infection, vascular graft infection, empyema, chronic prostatitis) or meningitis. Patients who initially do not have a confirmed diagnosis of these infections may be included; if the diagnosis is made subsequently, the patient may be kept in the trial at the discretion of the investigator, establishing the duration of treatment that he considers necessary. * Active empirical treatment\> 96 hours after initial blood culture extraction * Delay in inclusion\> 48 h * Recruited in another clinical trial with active treatment * Peritoneal dialysis or continuous hemofiltration

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Conditions

The condition(s) this trial relates to.

bacterial infectious disease with sepsis Toxemia

As listed by the trial registrant

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

Bacteremia

Contacts and locations

Locations

  • Complejo Hospitalario San Millán-San Pedro De La Rioja

    Logroño, La Rioja, 26560, Spain

  • Complejo Hospitalario Universitario La Coruña

    A Coruña, 15006, Spain

  • Complejo Hospitalario Universitario de Vigo

    Vigo, 36313, Spain

  • Complejo Hospitalario de Navarra

    Pamplona, Navarre, 31008, Spain

  • Hospital Clínico Universitario Virgen de la Arrixaca

    Murcia, 30120, Spain

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28007, Spain

  • Hospital General Universitario de Alicante

    Alicante, 03010, Spain

  • Hospital Marqués de Valdecilla

    Santander, Cantabria, 39008, Spain

  • Hospital ParcTaulí

    Sabadell, Barcelona, 08208, Spain

  • Hospital Regional de Málaga

    Málaga, 29010, Spain

  • Hospital Sant Pau

    Barcelona, 08041, Spain

  • Hospital Universitari Son Espases

    Palma, 07120, Spain

  • Hospital Universitario Clínico San Cecilio

    Granada, 18016, Spain

  • Hospital Universitario Juan Ramón Jiménez

    Huelva, 21005, Spain

  • Hospital Universitario Locus Augusti, Lugo

    Lugo, 27003, Spain

  • Hospital Universitario Mútua Terrassa

    Terrassa, Barcelona, 08221, Spain

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034, Spain

  • Hospital Universitario Reina Sofía

    Córdoba, 14004, Spain

  • Hospital Universitario Torrecárdenas

    Almería, 04009, Spain

  • Hospital Universitario Virgen Macarena

    Seville, 41009, Spain

  • Hospital Universitario Virgen de Valme

    Seville, 41014, Spain

  • Hospital Universitario Virgen de la Victoria

    Málaga, 29010, Spain

  • Hospital Universitario Virgen de las Nieves

    Granada, 18014, Spain

  • Hospital Universitario Virgen del Rocío

    Seville, 41013, Spain

  • Hospital Universitario de Cruces

    Barakaldo, Bizkaia, 48903, Spain

  • Hospital Universitario de Jerez de la Frontera

    Jerez de la Frontera, Cádiz, 11407, Spain

  • Hospital Universitario de Puerto Real

    Puerto Real, Cádiz, 11510, Spain

  • Hospital Universitario de la Princesa

    Madrid, 28006, Spain

  • Hospital del Mar

    Barcelona, 08003, Spain

More trials for these conditions

Other studies related to the condition(s) this trial covers.