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

NCT07322549 | Completed

• 1 other identifier: C-2025-006-MC
• Study Type: observational
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Severe Community-acquired Pneumonia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Susceptibility rate to AMC and/or 3GC for identified bacteria at CAP or CAAP diagnosis

  The antibiotics of interest are: * The combination of Amoxicillin/Clavulanic Acid (AMC) * Third-generation cephalosporins (3GCs)

  Up to 28 days

Secondary Outcomes (3)

• Patient characteristics according to AMC sensitivity

  Up to 28 days

• Susceptibility rate to empirical recommended beta lactam (AMC, 3GC, and piperacillin/tazobactam)

  Up to 28 days

• Mortality rate

  Up to 28 days

Study Arms (1)

Patients with severe community-acquired pneumonia

Pneumonia documented with Streptococcus pneumoniae, and/or Haemophilus influenzae, and/or Staphylococcus aureus

Other: Susceptibility to AMC; Other: Susceptibilty to 3GC

Interventions

Susceptibilty to 3GC OTHER

Susceptibilty to 3GC

Patients with severe community-acquired pneumonia

Susceptibility to AMC OTHER

Susceptibility to AMC

Patients with severe community-acquired pneumonia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer: lead

Study Sites (1)

Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

Toulon, Var, 83100, France

Location

MeSH Terms

Conditions

Community-Acquired Pneumonia; Haemophilus Infections; Staphylococcal Infections

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases; Pasteurellaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: January 7, 2026
• Study Start: March 1, 2025
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: April 14, 2026

Record last verified: 2026-04

Locations

FR (1)