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Compares treatment options for Community-acquired Pneumonia
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
ClinicalTrials.gov ID: NCT06229288
What this study is testing
What is Amoxicillin?
Amoxicillin is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for community-acquired pneumonia.
Also referred to as Experimental drug.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 65 and older
You may be able to join if
- 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...
- 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...
- 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...
You likely can't join if
- 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,
See the full eligibility criteria
- 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 \>...
- 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
- 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,
- Suspected atypical bacteria requiring combined antibiotics therapy,
- Legionella suspected,
- people 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 treatment study and having an exclusion period that is still in force during the screening phase or expected participation to another treatment study during participation to the CAPTAIN study
The study team makes the final eligibility decision.
Where it's taking place
- Saint-Nazaire, France, France
- Angers, France
- Bobigny, France
- Brest, France
- La Roche-sur-Yon, France
- La Tronche, France
- Marseille, France
- Nantes, France
- Périgueux, France
- Toulouse, France
- Vannes, France
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Saint-Nazaire, France, France; Angers, France; Bobigny, France; Brest, France; La Roche-sur-Yon, France; La Tronche, France and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.