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Completed

NCT Number: NCT07322549

Amoxicillin/Clavulanic Acid Susceptibility in Acute Community-acquired Pneumonia Requiring Intensive Care Management

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient admitted to the ICU at Sainte-Musse Hospital between January 2018 and December 2022.
  • 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

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

Treatment and study plan

Susceptibility to AMC

Other

Susceptibility to AMC

Susceptibilty to 3GC

Other

Susceptibilty to 3GC

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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.

  2. 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.
  3. 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).

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Other

Registry information

Official study title

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.

Acronym: CAP-ICU

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 7, 2026
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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