Community-acquired PneumoniaPhase 3CAPTAINNCT06229288
Amoxicillin Alone Versus Amoxicillin/Clavulanate for Community-acquired Pneumonia in Patients Aged 65 Years or Older, and Hospitalized in a Non-intensive Care Unit Ward
A Phase 3 study testing Amoxicillin and Amoxicillin/clavulanate in people with Community-acquired Pneumonia, run by Nantes University Hospital at 19 sites in France.
Trial summary
Reduce inappropriate antibiotic use is a priority of public health agencies. Community-acquired pneumonia (CAP) is one of the most important indications for antibiotic prescriptions. In the majority of the studies of CAP, there is a large proportion of cases with no pathogen identified. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Community-acquired Pneumonia
- What is being tested?
- Amoxicillin and Amoxicillin/clavulanate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 326 participants
- Where
- 19 sitesFrance
- Study dates
- 25 Apr 2024to 25 May 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patient aged 65 years or older with or without comorbidities defined by chronic diseases in immunocompetent patients,
- Patient admitted to the hospital for a CAP defined by at least two clinical signs of pneumonia (cough, sputum production, dyspnea, tachypnea, or pleuritic pain, abnormal lung auscultatory sounds, fever (temperature > 38°C) or hypothermia (<36°C)), and had radiological evidence of a new infiltrate confirming pneumonia
- Patient understanding oral and written French
- Written informed consent obtained from patient prior to participation in the study (if the patient is unable to express in writing: consent by a trusted person).
- Patients should be able to call and to answer to a phone call or to be with a relative who can help him to call or to answer questions notably raised by a medical staff belonging to the investigational site
Who cannot join
- Signs of severe CAP (abscess, massive pleural effusion, serious chronic respiratory insufficiency, ICU admission)
- Patient requiring ICU admission,
- Estimated Glomerular Filtration Rate < 30 ml/min,
- Known immunosuppression (asplenia, neutropenia, agammaglobulinemia, transplant, myeloma, lymphoma, known HIV and CD4<200/mm3),
- Exacerbation of chronic obstructive pulmonary disease,
- Life-threatening state expected to lead to possible imminent death,
Show all 20Show fewer
- Suspected atypical bacteria requiring combined antibiotics therapy,
- Legionella suspected,
- Subjects with clinical or epidemiological environment leading to suspect a healthcare associated pneumonia with antibiotic resistant pathogen (including long-term care facility)
- Patient known to be colonized with Pseudomonas aeruginosa or Enterobacteriaceae in the respiratory tract,
- Suspicion of aspiration pneumonia,
- Administration of any antibiotic treatment for more than 24 hours before inclusion,
- History of jaundice/hepatic impairment associated with amoxicillin/clavulanate acid,
- History of bacterial pneumonia less than 1 month prior to study inclusion
- History of hypersensitivity or allergy to beta-lactam or to any excipients included in study antibiotics,
- Subject without health insurance,
- Subject without home address or difficulty in terms of follow-up (vacation, job transfer, geographical distance, lack of motivation),
- Patient under judicial protection,
- Diagnosis confirmed of SAR-Cov2 infection (PCR Test, covid antigen rapid test, chest computed tomography (CT) scan),
- Participation to another interventional study and having an exclusion period that is still in force during the screening phase or expected participation to another interventional study during participation to the CAPTAIN study
Trial locations and contacts
19 sites in 1 country. Contact the study team or a site near you to ask about taking part.
19 sites in 1 country
France19 sites, 19 recruiting
- Recruiting
Chu Angers
Angers
Delphine PLARD, MD, 0241353637 ext. +33, delphine.plard@chu-angers.fr
- Recruiting
CHU Angers
Angers
Rafaël MAHIEU, MD, 0241353930 ext. +33, rafael.mahieu@chu-angers.fr
- Recruiting
CHU Avicenne AP-HP
Bobigny
Anne-Laure FERAL-PIERSSENS, MD, 0148955555 ext. +33, anne-laure.feral-pierssens@aphp.fr
- Recruiting
CHU Avicenne AP-HP
Bobigny
Frederic MECHAI, MD, 0148955428 ext. +33, frederic.mechai@aphp.fr
- Recruiting
CHRU Brest
Brest
Sylvain JAFFUEL, MD, 0298347213 ext. +33, sylvain.jaffuel@chu-brest.fr
- Recruiting
CHRU Brest
Brest
Rozenn LE BERRE, MD, 029822333 ext. +33, rozenn.leberre@chu-brest.fr
- Recruiting
CHD Vendée
La Roche-sur-Yon
Sylvaine LE GENTIL, MD, 0251446378 ext. +33, sylvain.legentil@ght85.fr
- Recruiting
CHD Vendée
La Roche-sur-Yon
Dominique MERRIEN, MD, 0251446385 ext. +33, dominique.merrien@ght85.fr
- Recruiting
CHU Grenoble-Alpes
La Tronche
Damien VIGLINO, MD, 0476766784 ext. +33, DViglino@chu-grenoble.fr
- Recruiting
CHU Grenoble-Alpes
La Tronche
Perrine DUMANOIR, MD, 0476767088 ext. +33, PDumanoir@chu-grenoble.fr
- Recruiting
Assistance Publique Hopitaux De Marseille
Marseille
Aurélie DAUMAS, MD, 0491388719 ext. +33, aurelie.daumas@ap-hm.fr
- Recruiting
CHU de Nantes
Nantes
Emmanuel MONTASSIER, MD, 0253482038 ext. +33, emmanuel.montassier@chu-nantes.fr
Emmanuel Montassier, MD
- Recruiting
CH Perigueux
Périgueux
Alexandrine VIDAL, MD, 0553452525 ext. +33, alexandrine.vidal@ch-perigueux.fr
- Recruiting
CH Saint-Nazaire
Saint-Nazaire, France, 44600
Matthieu THIBAULT, Doctor, 0272278174 ext. +33, m.thibault@ch-saintnazaire.fr
Matthieu THIBAULT, Doctor
- Recruiting
CH Saint-Nazaire
Saint-Nazaire, France, 44600
Dorothée BOISSEAU, Doctor, 0272278434 ext. +33, d.boisseau@ch-saintnazaire.fr
- Recruiting
CHRU - TOULOUSE Hôpital Purpan
Toulouse
Frederic BALEN, MD, 0561772579 ext. +33, balen.f@chu-toulouse.fr
- Recruiting
CHRU - TOULOUSE Hôpital Purpan
Toulouse
Guillaume MARTIN-BLONDEL, MD, 0561779699 ext. +33, martin-blondel.g@chu-toulouse.fr
- Recruiting
CHRU TOULOUSE - Hôpital Rangueuil
Toulouse
Xavier DUBUCS, MD, 0561775919 ext. +33, dubucs.x@chu-toulouse.fr
- Recruiting
Centre Hospitalier Bretagne Atlantique
Vannes
Pierre BARSI, MD, 0297014893 ext. +33, pierre.barsi@ch-bretagne-atlantique.fr
About this study
Official title: Amoxicillin Alone Versus Amoxicillin/Clavulanate for Community-acquired Pneumonia in Patients Aged 65 Years or Older, and Hospitalized in a Non-intensive Care Unit Ward: a Non-inferiority Randomized Controlled Trial
Reduce inappropriate antibiotic use is a priority of public health agencies. Community-acquired pneumonia (CAP) is one of the most important indications for antibiotic prescriptions.
In the majority of the studies of CAP, there is a large proportion of cases with no pathogen identified. Thus, the choice of the empirical antibiotic depends on the most likely pathogen, individual risk factors, comorbidities, and allergies.
Patients aged 65 years or older are often treated with amoxicillin/clavulanate or with another broad-spectrum antibiotic (third-generation cephalosporins, antipneumococcal fluoroquinolone). However, broad-spectrum antibiotic prescription in CAP is debated and concerns exist about side-effects and selective pressure for resistance. Due to lack of head-to-head antibiotic comparisons, a recent Cochrane review concluded that current evidence from Randomized Clinical Trials (RCTs) is insufficient to make evidence-based recommendations for the choice for antibiotic to be used, highlighting an important evidence gap.
Read the detailed description
Thus, the goal of the proposed trial is to compare clinical efficacy and safety of two CAP antimicrobial treatments, amoxicillin and amoxicillin/clavulanate, in patients aged 65 years or older and hospitalized in a non-intensive care unit (ICU) ward. The CAPTAIN study will be a multi-center, randomized, open, non-inferiority trial comparing clinical efficacy at Day 30 among patients ≥65 years of age, and hospitalized in a non-ICU ward, treated with narrow-spectrum (amoxicillin) versus broad-spectrum (amoxicillin/clavulanate) antimicrobial therapy for CAP. This will be a pivotal clinical trial that will provide evidence to inform CAP treatment guidelines.
- Conditions
- Community-acquired Pneumonia
- Being tested
- Amoxicillin, Amoxicillin/clavulanate
- Keywords
- Community-acquired pneumonia, Amoxicillin, Amoxicillin/clavulanate
- Medical subject headings
- Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmoxicillinDrug
Also called Experimental drug
Participants will be randomized to IV/oral amoxicillin or IV/oral amoxicillin/clavulanate for 5 days. Both agents are approved for treatment of respiratory infections.
Amoxicillin PO: The dose is two capsule of 500 mg every 8 hours (that is 3 times daily).
Amoxicillin IV: The dose is 1 g every 8 hours (that is 3 times daily)
Amoxicillin/clavulanateDrug
Also called active comparator drug
Participants will be randomized to IV/oral amoxicillin or IV/oral amoxicillin/clavulanate for 5 days. Both agents are approved for treatment of respiratory infections.
Amoxicillin/clavulanate PO: The dose is two tablets of 500 mg/62.5 mg every 8 hours (that is 3 times daily, approved standard dose) Amoxicillin/clavulanate IV: The dose is 1 g/200 mg every 8 hours (that is 3 times daily, approved standard dose)
| Study group | Role | What they receive |
|---|---|---|
| Amoxicillin | Experimental | Amoxicillin is an antibiotic treatment approved in France and in many countries.
The investigational medicinal products (IMPs) are:
- Amoxicillin capsules : Formulated as a 500 mg capsules for PO administration (commercially available). Description in IMP file.
Amoxicillin capsules contain compendial excipients listed in the Summary Product Characteristics (SmPC), current version, and are kept in a cool dry place where the temperature stays at 15- 25°C.
- Amoxicillin IV vials : Formulated as a 1000 mg vial for IV administration (commercially available). Description in IMP file.
Amoxicillin IV vials contain compendial excipient listed in the Summary Product Characteristics (SmPC), current version, and are kept in a cool dry place where the temperature stays at 15-25°C. Receives: Drug: Amoxicillin |
| Amoxicillin/clavulanate | Active comparator | Amoxicillin/clavulanate is recommended by French and European guidelines for the treatment of patients aged 65 years or older, and hospitalized in a non-ICU ward, as reported above.
The active comparators (IMPs) are:
- Amoxicillin/clavulanate tablets: Formulated as a tablet for PO administration (commercially available). Description in IMP file. Tablets contain 500 mg of amoxicillin trihydrate and 62.5 mg of clavulanate. Amoxicillin/clavulanate tablets contain compendial excipients listed in the Summary Product Characteristics (SmPC), current version, and are kept in a cool dry place where the temperature stays at 15-25°C.
- Amoxicillin/clavulanate vials Vials contain 1000 mg of amoxicillin and 200 mg of clavulanate. Description in IMP file.
Amoxicillin/clavulanate vials contain compendial excipients listed in the Summary Product Characteristics (SmPC), current version, and are kept in a cool dry place where the temperature stays at 15-25°C Receives: Drug: Amoxicillin/clavulanate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-inferiority
To investigate non-inferiority in terms of clinical efficacy among patients aged 65 years or older, hospitalized in a non-ICU ward for a CAP, and treated with narrow-spectrum (amoxicillin) versus broad-spectrum (amoxicillin/clavulanate) antimicrobial therapy, at Day 30 since hospital admission. To answer this question, clinical success rate at Day 30 since admission, defined as survival after completion of antibiotic treatment course, resolution of signs and symptoms of the infection (cough, purulent sputum production, dyspnea, or pleuritic chest pain) present at baseline with no new symptoms or complications attributable to CAP and no need for further antibacterial therapy will be determined
Measured: Day 30 after inclusion (=Day 1)
Secondary outcomes (12)
Rates of early clinical response
Early clinical response will be defined as survival with improvement of one or more levels relative to baseline in two or more symptoms of CAP and no worsening of one or more levels in other symptoms of community-acquired bacterial pneumonia, without receipt of rescue antibacterial therapy
Measured: Day 3 after inclusion (=Day 1)
Clinical cure after the end of treatment
The proposed endpoint of clinical cure after the end of treatment is defined as resolution in relevant signs and symptoms reported at baseline, no worsening of symptoms, and no change in antimicrobial regimen
Measured: Within 30 days after inclusion (=Day 1) compared to baseline
To investigate total duration of antibiotic treatment, i.e., the total number of days with antibiotics during the Day 30 follow-up after hospital admission
Days taking antibiotics from the first dose until the interruption of any antibiotic treatment during hospitalization and at late follow-up at Day 30 after hospital admission (to identify the use of any other antibiotic after hospital discharge defined as no IV, regain of autonomy identical to baseline, good clinical response and favorable evolution following initiation of antibiotics, other criteria left at the discretion of the investigators according to centers' practices)
Measured: Day 30 after inclusion (=Day 1)
To investigate all-cause mortality at Day 30 after hospital admission
All-cause mortality at Day 30 after hospital admission
Measured: Day 30 after inclusion (=Day 1)
To investigate the rate of polymerase chain reaction (PCR)-positive Clostridium difficile among patients with diarrhea
Number of positive polymerase chain reaction (PCR)-positive Clostridium difficile among patients with diarrhea
Measured: Within 30 days after inclusion (=Day 1)
To investigate in-hospital mortality
Number of deaths during hospitalization
Measured: Within 30 days after inclusion (=Day 1)
To investigate ICU transfer during the Day 30 follow-up
Number of patients transferred to the ICU during the Day 30 follow-up
Measured: Day 30 after inclusion (=Day 1)
To investigate CAP recurrence and hospital readmissions up to day 30 from hospital admission
Number of hospital readmissions and CAP recurrence up to day 30 from hospital admission
Measured: Day 30 after inclusion (=Day 1)
To investigate adverse events attributable to antibiotics up to day 30 from hospital admission
Number of adverse events attributable to antibiotics and number of days with adverse events up to day 30 from hospital admission
Measured: Day 30 after inclusion (=Day 1)
To investigate compliance with the antibiotic treatment
Number of days of antibiotic treatment taken
Measured: Within 7 days after inclusion (=Day 1)
To investigate length of hospital stay
Measured: Within 30 days after inclusion (=Day 1)
Analysis of sensitivity todiscordance
To investigate the agreement between the early clinical response endpoint and the investigator's clinical judgment: the agreement between early clinical response (main endpoint) and the investigator's clinical judgement (clinical success or clinical failure) will be assessed
Measured: Within 30 days after inclusion (=Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start25 Apr 2024
- Primary completion25 May 2027 (estimated)
- Study completion25 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community-acquired PneumoniaStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Drug study, multi-centre, Phase 3, Controlled , Randomized, Open, Prospective
- Masking
- None (open label)
- Enrolment
- 326 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frederic BALEN, Doctor, Principal investigator, Toulouse UHGuillaume MARTIN-BLONDEL, Doctor, Principal investigator, Toulouse UHPerrine DUMANOIR, Doctor, Principal investigator, Grenoble HospitalVIGLINO Damien, Doctor, Principal investigator, Grenoble HospitalAlexandrine VIDAL, Doctor, Principal investigator, Perigueux HospitalDelphine PLARD, Doctor, Principal investigator, Angers UHRafaël MAHIEU, Doctor, Principal investigator, Angers UHAnne-Laure FERAL-PIERSSENS, Doctor, Principal investigator, Avicenne AP-HP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06229288
- Sponsor's protocol ID
- RC20_0015
- Acronym
- CAPTAIN
- Status last verified
- Apr 2026
- First submitted
- 10 Jan 2024
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amoxicillin Alone Versus Amoxicillin/Clavulanate for Community-acquired Pneumonia in Patients Aged 65 Years or Older, and Hospitalized in a Non-intensive Care Unit Ward: a Non-inferiority Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06229288
- Acronym / sponsor ID
- CAPTAIN / RC20_0015
- Conditions
- Community-acquired Pneumonia
- Keywords
- Community-acquired pneumonia, Amoxicillin, Amoxicillin/clavulanate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 326 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 25 Apr 2024 (actual)
- Primary completion
- 25 May 2027 (estimated)
- Study completion
- 25 May 2027 (estimated)
- First posted
- 29 Jan 2024 (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.
Reduce inappropriate antibiotic use is a priority of public health agencies. Community-acquired pneumonia (CAP) is one of the most important indications for antibiotic prescriptions.
In the majority of the studies of CAP, there is a large proportion of cases with no pathogen identified. Thus, the choice of the empirical antibiotic depends on the most likely pathogen, individual risk factors, comorbidities, and allergies.
Patients aged 65 years or older are often treated with amoxicillin/clavulanate or with another broad-spectrum antibiotic (third-generation cephalosporins, antipneumococcal fluoroquinolone). However, broad-spectrum antibiotic prescription in CAP is debated and concerns exist about side-effects and selective pressure for resistance. Due to lack of head-to-head antibiotic comparisons, a recent Cochrane review concluded that current evidence from Randomized Clinical Trials (RCTs) is insufficient to make evidence-based recommendations for the choice for antibiotic to be used, highlighting an important evidence gap.
Detailed description
Thus, the goal of the proposed trial is to compare clinical efficacy and safety of two CAP antimicrobial treatments, amoxicillin and amoxicillin/clavulanate, in patients aged 65 years or older and hospitalized in a non-intensive care unit (ICU) ward. The CAPTAIN study will be a multi-center, randomized, open, non-inferiority trial comparing clinical efficacy at Day 30 among patients ≥65 years of age, and hospitalized in a non-ICU ward, treated with narrow-spectrum (amoxicillin) versus broad-spectrum (amoxicillin/clavulanate) antimicrobial therapy for CAP. This will be a pivotal clinical trial that will provide evidence to inform CAP treatment guidelines.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Drug study, multi-centre, Phase 3, Controlled , Randomized, Open, Prospective
| Arm | Type | Receives |
|---|---|---|
| Amoxicillin | Experimental | Drug: AmoxicillinAmoxicillin is an antibiotic treatment approved in France and in many countries. The investigational medicinal products (IMPs) are: - Amoxicillin capsules : Formulated as a 500 mg capsules for PO administration (commercially available). Description in IMP file. Amoxicillin capsules contain compendial excipients listed in the Summary Product Characteristics (SmPC), current version, and are kept in a cool dry place where the temperature stays at 15- 25°C. - Amoxicillin IV vials : Formulated as a 1000 mg vial for IV administration (commercially available). Description in IMP file. Amoxicillin IV vials contain compendial excipient listed in the Summary Product Characteristics (SmPC), current version, and are kept in a cool dry place where the temperature stays at 15-25°C. |
| Amoxicillin/clavulanate | Active comparator | Drug: Amoxicillin/clavulanateAmoxicillin/clavulanate is recommended by French and European guidelines for the treatment of patients aged 65 years or older, and hospitalized in a non-ICU ward, as reported above. The active comparators (IMPs) are: - Amoxicillin/clavulanate tablets: Formulated as a tablet for PO administration (commercially available). Description in IMP file. Tablets contain 500 mg of amoxicillin trihydrate and 62.5 mg of clavulanate. Amoxicillin/clavulanate tablets contain compendial excipients listed in the Summary Product Characteristics (SmPC), current version, and are kept in a cool dry place where the temperature stays at 15-25°C. - Amoxicillin/clavulanate vials Vials contain 1000 mg of amoxicillin and 200 mg of clavulanate. Description in IMP file. Amoxicillin/clavulanate vials contain compendial excipients listed in the Summary Product Characteristics (SmPC), current version, and are kept in a cool dry place where the temperature stays at 15-25°C |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Patient aged 65 years or older with or without comorbidities defined by chronic diseases in immunocompetent patients,
- Patient admitted to the hospital for a CAP defined by at least two clinical signs of pneumonia (cough, sputum production, dyspnea, tachypnea, or pleuritic pain, abnormal lung auscultatory sounds, fever (temperature > 38°C) or hypothermia (<36°C)), and had radiological evidence of a new infiltrate confirming pneumonia
- Patient understanding oral and written French
- Written informed consent obtained from patient prior to participation in the study (if the patient is unable to express in writing: consent by a trusted person).
- Patients should be able to call and to answer to a phone call or to be with a relative who can help him to call or to answer questions notably raised by a medical staff belonging to the investigational site
Key exclusion criteria (20 listed)
- Signs of severe CAP (abscess, massive pleural effusion, serious chronic respiratory insufficiency, ICU admission)
- Patient requiring ICU admission,
- Estimated Glomerular Filtration Rate < 30 ml/min,
- Known immunosuppression (asplenia, neutropenia, agammaglobulinemia, transplant, myeloma, lymphoma, known HIV and CD4<200/mm3),
- Exacerbation of chronic obstructive pulmonary disease,
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 |
|---|---|---|
| AmoxicillinAlso: Experimental drugParticipants will be randomized to IV/oral amoxicillin or IV/oral amoxicillin/clavulanate for 5 days. Both agents are approved for treatment of respiratory infections. Amoxicillin PO: The dose is two capsule of 500 mg every 8 hours (that is 3 times daily). Amoxicillin IV: The dose is 1 g every 8 hours (that is 3 times daily) | Drug | Amoxicillin |
| Amoxicillin/clavulanateAlso: active comparator drugParticipants will be randomized to IV/oral amoxicillin or IV/oral amoxicillin/clavulanate for 5 days. Both agents are approved for treatment of respiratory infections. Amoxicillin/clavulanate PO: The dose is two tablets of 500 mg/62.5 mg every 8 hours (that is 3 times daily, approved standard dose) Amoxicillin/clavulanate IV: The dose is 1 g/200 mg every 8 hours (that is 3 times daily, approved standard dose) | Drug | Amoxicillin/clavulanate |
Primary outcome
Non-inferiority
Time frame: Day 30 after inclusion (=Day 1)
To investigate non-inferiority in terms of clinical efficacy among patients aged 65 years or older, hospitalized in a non-ICU ward for a CAP, and treated with narrow-spectrum (amoxicillin) versus broad-spectrum (amoxicillin/clavulanate) antimicrobial therapy, at Day 30 since hospital admission. To answer this question, clinical success rate at Day 30 since admission, defined as survival after completion of antibiotic treatment course, resolution of signs and symptoms of the infection (cough, purulent sputum production, dyspnea, or pleuritic chest pain) present at baseline with no new symptoms or complications attributable to CAP and no need for further antibacterial therapy will be determined
12 secondary outcomes
Rates of early clinical response
Time frame: Day 3 after inclusion (=Day 1)
Clinical cure after the end of treatment
Time frame: Within 30 days after inclusion (=Day 1) compared to baseline
To investigate total duration of antibiotic treatment, i.e., the total number of days with antibiotics during the Day 30 follow-up after hospital admission
Time frame: Day 30 after inclusion (=Day 1)
To investigate all-cause mortality at Day 30 after hospital admission
Time frame: Day 30 after inclusion (=Day 1)
To investigate the rate of polymerase chain reaction (PCR)-positive Clostridium difficile among patients with diarrhea
Time frame: Within 30 days after inclusion (=Day 1)
To investigate in-hospital mortality
Time frame: Within 30 days after inclusion (=Day 1)
To investigate ICU transfer during the Day 30 follow-up
Time frame: Day 30 after inclusion (=Day 1)
To investigate CAP recurrence and hospital readmissions up to day 30 from hospital admission
Time frame: Day 30 after inclusion (=Day 1)
To investigate adverse events attributable to antibiotics up to day 30 from hospital admission
Time frame: Day 30 after inclusion (=Day 1)
To investigate compliance with the antibiotic treatment
Time frame: Within 7 days after inclusion (=Day 1)
To investigate length of hospital stay
Time frame: Within 30 days after inclusion (=Day 1)
Analysis of sensitivity todiscordance
Time frame: Within 30 days after inclusion (=Day 1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 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.
Frederic BALEN, Doctor principal investigator
Toulouse UH
Guillaume MARTIN-BLONDEL, Doctor principal investigator
Toulouse UH
Perrine DUMANOIR, Doctor principal investigator
Grenoble Hospital
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Amoxicillin and Amoxicillin/clavulanate in people with Community-acquired Pneumonia, run by Nantes University Hospital at 19 sites 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 5 inclusion and 20 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: looking for participants now, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emmanuel MONTASSIER, Professor (02 53 48 20 38 ext. +33, emmanuel.montassier@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-inferiority (time frame: Day 30 after inclusion (=Day 1)). 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 8 Apr 2026.