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Can less be more? new study tests cutting antibiotics in cancer patients with sepsis

NCT ID NCT03683329

Disease control Sponsor: Institut Paoli-Calmettes Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looked at whether reducing the use of strong, broad-spectrum antibiotics in cancer patients with sepsis or septic shock is as safe as continuing them. The goal is to lower the risk of creating drug-resistant bacteria. Researchers compared a de-escalation strategy to standard antibiotic treatment in 398 patients in intensive care.

What this could mean

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

Active substance
Antibiotic de-escalation strategy
What this could lead to
If successful, this could show that reducing antibiotic use in cancer patients with severe infections is safe, helping to slow the rise of drug-resistant bacteria.
What could go wrong
This is a completed trial, but results may not apply to all cancer patients. The strategy might not be as safe as standard care, and individual patient factors could affect outcomes.

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

398 people

The number who actually took part.

Started

Nov 2018

Finished

Jul 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: 1. Written informed consent from the patient or proxy (if present) before inclusion or once possible when patient has been included in a context of emergency 2. Age ≥ 18 years, 3. Onco-hematology patient admitted to intensive care for sepsis or septic shock according to the following criteria: * Sepsis: * A suspected infection * And an acute increase of ≥ 2 SOFA points (a proxy for organ dysfunction) * Septic shock: * sepsis * and vasopressor therapy needed to elevate MAP ≥65 mm Hg and lactate \>2 mmol/L despite adequate fluid resuscitation 4. Patient treated with an empirical antibiotic treatment, 5. Patient with at least one microbiological sample collected at least within the first 48 hours following the diagnosis of sepsis in ICU 6. Patient with an identified infectious site according to the definitions, 7. Patient with an identified bacteria microorganism after microbiological examination, 8. Patient affiliated to the national French statutory healthcare insurance system or beneficiary of this regimen. Exclusion Criteria: 1. Patient colonized with a multi-drug resistant organisms preventing de-escalation antibiotic, 2. Pregnant or breast-feeding woman, 3. No affiliation to the national French statutory healthcare insurance system, 4. Patients deprived of liberty or placed under the authority of a tutor, 5. Inappropriate probabilistic antibiotic treatment, 6. Expected mortality within 48 hours, 7. Patient admitted to the ICU for end-of-life care (do-not-resuscitate patients) . Do-not-intubate (DNI) patients can be included.

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Conditions

The condition(s) this trial relates to.

cancer infectious disease with sepsis neoplasm Sepsis toxic shock syndrome

As listed by the trial registrant

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

Cancer Critical care

Contacts and locations

Locations

  • Institut Paoli Calmettes

    Marseille, 13273, France

More trials for these conditions

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