Amoxicillin/Clavulanic Acid Susceptibility in Acute Community-acquired Pneumonia Requiring Intensive Care Management (CAP-ICU)

April 13, 2026 updated by: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Amoxicillin/Clavulanic Acid Susceptibility in Acute Community-acquired Pneumonia Documented With Streptococcus Pneumoniae, Haemophilus Influenzae, or Staphylococcus Aureus Requiring Intensive Care Management: a Single-center Retrospective Study.

Severe community-acquired pneumonia (CAP) and community-acquired aspiration pneumonia (CAAP) are common reasons for adult emergency department visits and subsequent admission to the intensive care unit (ICU). Three bacteria are primarily implicated in this type of pneumonia: Streptococcus pneumoniae, Haemophilus influenzae, and Staphylococcus aureus.

Empirical antibiotic therapy for this condition is currently based on the use of beta-lactams. While third-generation cephalosporins (3GC) remain the beta-lactam of choice in French guidelines for CAP, the combination of Amoxicillin/Clavulanic Acid (AMC) at high-dose (>3g/day) could represent an alternative. AMC is already recommended for severe CAAP and for non-severe CAP in France, and for severe CAP in the UK and the United States. Furthermore, good practice guidelines encourage the use of empirical antibiotic therapies that are then subsequently tailored to the narrowest-spectrum agents based on antibiograms. This approach aims to limit the emergence of multidrug-resistant bacteria and reduce the risk of Clostridioides difficile colitis, which can increase patient morbidity and mortality.

This study aims to evaluate the susceptibility to AMC and 3GC, and to describe the empirical antibiotic therapies used and their subsequent adjustments, in adult patients admitted to the ICU for severe CAP and CAAP documented with Streptococcus pneumoniae, and/or Haemophilus influenzae, and/or Staphylococcus aureus.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Observational retrospective monocentric cohort including all the consecutive adult ICU patients admitted from january 2018 to november 2022 with a CAP or a CAAP documented to Streptococcus pneumoniae, and/or Haemophilus influenzae, and/or Staphylococcus aureus.

Study Type

Observational

Enrollment (Actual)

104

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Var
      • Toulon, Var, France, 83100
        • Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients admitted to the ICU at Sainte-Musse Hospital between January 2018 and December 2022 with a diagnosis of severe CAP or CAAP

Description

Inclusion Criteria:

  1. Patient admitted to the ICU at Sainte-Musse Hospital between January 2018 and December 2022.
  2. Diagnosis of severe CAP or CAAP within 48 hours of hospital admission, documented with Streptococcus pneumoniae, and/or Haemophilus influenzae, and/or Staphylococcus aureus (confirmed by blood culture and/or a respiratory sample), with an available antibiogram.

Exclusion Criteria:

  1. Patient under 18 years old.
  2. Patient hospitalized within 3 months prior to hospital admission.
  3. Infectious documentation of another pathogen within 48 hours of hospital admission.
  4. Nosocomial pneumonia.
  5. Patient under legal guardianship (inmate, legal ward, curatorship).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with severe community-acquired pneumonia
Pneumonia documented with Streptococcus pneumoniae, and/or Haemophilus influenzae, and/or Staphylococcus aureus
Other: Susceptibility to AMC
Susceptibility to AMC
Other: Susceptibilty to 3GC
Susceptibilty to 3GC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Susceptibility rate to AMC and/or 3GC for identified bacteria at CAP or CAAP diagnosis
Time Frame: Up to 28 days

The antibiotics of interest are:

  • The combination of Amoxicillin/Clavulanic Acid (AMC)
  • Third-generation cephalosporins (3GCs)
Up to 28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient characteristics according to AMC sensitivity
Time Frame: Up to 28 days
Comparison of patients' characteristics (chronic disease, ICU parameters) according to CAP with a documented bacteria susceptible to AMC or not.
Up to 28 days
Susceptibility rate to empirical recommended beta lactam (AMC, 3GC, and piperacillin/tazobactam)
Time Frame: Up to 28 days

The rates of antibiotic use will be analyzed according to the following criteria:

  • Inappropriate: Inappropriate antibiotic spectrum.
  • Appropriate: Antibiotic spectrum appropriate for the identified pathogen.
  • Unjustified: Overly broad antibiotic spectrum.
Up to 28 days
Mortality rate
Time Frame: Up to 28 days
Mortality at ICU discharge will be assessed overall and stratified by the appropriateness of antibiotic therapy (classified as inappropriate, appropriate, or unjustified).
Up to 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2025

Primary Completion (Actual)

September 30, 2025

Study Completion (Actual)

September 30, 2025

Study Registration Dates

First Submitted

December 1, 2025

First Submitted That Met QC Criteria

December 29, 2025

First Posted (Actual)

January 7, 2026

Study Record Updates

Last Update Posted (Actual)

April 14, 2026

Last Update Submitted That Met QC Criteria

April 13, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-2025-006-MC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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