Severe Community-acquired PneumoniaCAP-ICUNCT07322549
Amoxicillin/Clavulanic Acid Susceptibility in Acute Community-acquired Pneumonia Requiring Intensive Care Management
An observational study of Severe Community-acquired Pneumonia, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Community-acquired Pneumonia
- What is being tested?
- Susceptibility to AMC and Susceptibilty to 3GC
- How many people
- 104 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2025to 30 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
Toulon, Var, 83100
About this study
Official 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.
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.
Read the 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.
- Conditions
- Severe Community-acquired Pneumonia
- Being tested
- Susceptibility to AMC, Susceptibilty to 3GC
- Keywords
- Community-acquired pneumonia, Community-asquired aspiration pneumonia, Intensive care, Streptococcus pneumoniæ, Haemophilus influenzae, Staphylococcus aureus
- Medical subject headings
- Community-Acquired Pneumonia, Haemophilus Infections, Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Susceptibility to AMCOther
Susceptibility to AMC
Susceptibilty to 3GCOther
Susceptibilty to 3GC
| Study group | Role | What they receive |
|---|---|---|
| Patients with severe community-acquired pneumonia | Pneumonia documented with Streptococcus pneumoniae, and/or Haemophilus influenzae, and/or Staphylococcus aureus Receives: Other: Susceptibility to AMC; Other: Susceptibilty to 3GC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Up to 28 days
Secondary outcomes (3)
Patient characteristics according to AMC sensitivity
Comparison of patients' characteristics (chronic disease, ICU parameters) according to CAP with a documented bacteria susceptible to AMC or not.
Measured: Up to 28 days
Susceptibility rate to empirical recommended beta lactam (AMC, 3GC, and piperacillin/tazobactam)
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.
Measured: Up to 28 days
Mortality rate
Mortality at ICU discharge will be assessed overall and stratified by the appropriateness of antibiotic therapy (classified as inappropriate, appropriate, or unjustified).
Measured: Up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start1 Mar 2025
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Community-acquired PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07322549
- Sponsor's protocol ID
- C-2025-006-MC
- Acronym
- CAP-ICU
- Status last verified
- Jul 2026
- First submitted
- 1 Dec 2025
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT07322549
- Acronym / sponsor ID
- CAP-ICU / C-2025-006-MC
- Conditions
- Severe Community-acquired Pneumonia
- Keywords
- Community-acquired pneumonia, Community-asquired aspiration pneumonia, Intensive care, Streptococcus pneumoniæ, Haemophilus influenzae, Staphylococcus aureus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur MerUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 7 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with severe community-acquired pneumonia | – | Other: Susceptibility to AMC, Other: Susceptibilty to 3GCPneumonia documented with Streptococcus pneumoniae, and/or Haemophilus influenzae, and/or Staphylococcus aureus |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Susceptibility to AMCSusceptibility to AMC | Other | Patients with severe community-acquired pneumonia |
| Susceptibilty to 3GCSusceptibilty to 3GC | Other | Patients with severe community-acquired pneumonia |
Primary outcome
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)
3 secondary outcomes
Patient characteristics according to AMC sensitivity
Time frame: Up to 28 days
Susceptibility rate to empirical recommended beta lactam (AMC, 3GC, and piperacillin/tazobactam)
Time frame: Up to 28 days
Mortality rate
Time frame: Up to 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Community-acquired Pneumonia, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Susceptibility rate to AMC and/or 3GC for identified bacteria at CAP or CAAP diagnosis (time frame: Up to 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.