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How do antifungals behave in septic shock? small study aims to find out

NCT ID NCT02805049

Knowledge-focused Sponsor: Centre Hospitalier Universitaire de Nīmes 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 completed Phase 4 study looked at how the body processes echinocandin antifungal drugs (caspofungin or micafungin) in 24 adults with septic shock caused by peritonitis. Researchers measured drug levels in the blood to understand clearance, distribution, and concentration. The goal was to gather knowledge for better dosing, not to test a new treatment.

What this could mean

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

Active substance
Echinocandins (caspofungin or micafungin)
What this could lead to
If successful, this could help doctors better dose echinocandins for septic shock patients with abdominal infections, potentially improving treatment outcomes.
What could go wrong
This is a small, completed pharmacokinetic study with only 24 participants, so results may not apply broadly. It does not test whether the drugs improve survival or cure the infection.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

24 people

The number who actually took part.

Started

Jan 2017

Finished

Jun 2018

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: * The emergency inclusion procedure was correctly applied according to French law (signature of consent form by a patient-designated trusted person or a family member, or a medical decision to proceed with patient inclusion if the latter two persons are unavailable) ---- OR ---- signature of the consent form by the patient * The patient must be insured or beneficiary of a health insurance plan * The patient is 18 years of age or older * The patient has beed admitted to the ICU for septic shock accompanying secondary peritonitis * Patient requiring antifungal treatment via echinocandins (caspofungin or micafungin) * A venous or arterial access for blood sampling is already in place for routine care Exclusion Criteria: * The patient is participating in an interventional study that may affect the results of the present study, or has participated in such a study within the past 3 months * The patient is under judicial protection, or is an adult under guardianship * The patient is pregnant, parturient or breastfeeding * Moribund patient * Known positive serology for human immunodeficiency virus (HIV) * Known positive serology for hepatitis C * Known diagnosis for tuberculosis

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Conditions

The condition(s) this trial relates to.

peritonitis toxic shock syndrome

As listed by the trial registrant

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

Peritonitis Septic shock

Contacts and locations

Locations

  • CHU de Nîmes - Hôpital Universitaire Carémeau

    Nîmes, 30029, France

  • Royal Brisbane Women's Hospital

    Herston, 4029, Australia

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