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

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.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07322549
Acronym
CAP-ICU
Enrollment
104
Registered
2026-01-07
Start date
2025-03-01
Completion date
2025-09-30
Last updated
2026-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe Community-acquired Pneumonia

Keywords

Community-acquired pneumonia, Community-asquired aspiration pneumonia, Intensive care, Streptococcus pneumoniæ, Haemophilus influenzae, Staphylococcus aureus

Brief summary

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.

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.

Interventions

OTHERSusceptibility to AMC

Susceptibility to AMC

OTHERSusceptibilty to 3GC

Susceptibilty to 3GC

Sponsors

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Susceptibility rate to AMC and/or 3GC for identified bacteria at CAP or CAAP diagnosisUp to 28 daysThe antibiotics of interest are: * The combination of Amoxicillin/Clavulanic Acid (AMC) * Third-generation cephalosporins (3GCs)

Secondary

MeasureTime frameDescription
Patient characteristics according to AMC sensitivityUp to 28 daysComparison of patients' characteristics (chronic disease, ICU parameters) according to CAP with a documented bacteria susceptible to AMC or not.
Susceptibility rate to empirical recommended beta lactam (AMC, 3GC, and piperacillin/tazobactam)Up to 28 daysThe 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.
Mortality rateUp to 28 daysMortality at ICU discharge will be assessed overall and stratified by the appropriateness of antibiotic therapy (classified as inappropriate, appropriate, or unjustified).

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 8, 2026