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New treatment option for Community-Acquired Pneumonia
Official title Customized Antibiotic Treatment Duration Among Hospitalized Patients With Moderately Severe Community-Acquired Pneumonia
ClinicalTrials.gov ID: NCT05903352
What this study is testing
What is Continue the antimicrobial treatment?
Continue the antimicrobial treatment is an investigational medicine, being studied as a potential treatment for community-acquired pneumonia.
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
- The primary objective of the study is to evaluate if the efficacy of an experimental strategy on antibiotic treatment duration based on stopping treatment when stability criteria are reached after at least 48 h of treatment, is non-inferior to the efficacy of standard antibiotic duration in CAP patients treated in the hospital setting. As the secondary objectives, the study aims To study if the efficacy of our experimental strategy on antibiotic treatment duration compared to standard of care in CAP patients treated in the hospital setting is non-inferior in terms of: Persistence of cure at Day 30 of antibiotic treatment All-cause mortality rate on Day 30 of antibiotic treatment Patients evolution of pneumonia symptoms and quality of life via 2 scores (CAP score, CAP Sym) at Day 0 of treatment (retrospectively), at stability (Day S), at Day 7 , at Day 15, and at Day 30 of antibiotic treatment.
- 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 18 and older
You may be able to join if
- Adult patient (≥18 years old)
- Admitted to hospital for suspected CAP defined by the presence of at least 2 of the following diagnostic clinical criteria:
- Fever (temperature \> 38°C) or hypothermia (\< 36°C)
- Dyspnea
- Cough
You likely can't join if
- Signs of severe CAP (abscess, massive pleural effusion, serious chronic respiratory insufficiency)
- Known immunosuppression (asplenia, neutropenia, agammaglobulinemia, transplant, myeloma, lymphoma, known HIV and CD4\<200/mm3)
- Suspected or confirmed legionellosis
- Any other infection necessitating concomitant antibiotic treatment
- Confirmed or suspected aspiration pneumonia or healthcare-associated pneumonia
- Treatment of suspected CAP with azithromycin (due to its prolonged half-life)
See the full eligibility criteria
- Adult patient (≥18 years old)
- Admitted to hospital for suspected CAP defined by the presence of at least 2 of the following diagnostic clinical criteria:
- Fever (temperature \> 38°C) or hypothermia (\< 36°C)
- Dyspnea
- Cough
- Production of purulent sputum
- Crackles
- Radiological evidence of a new infiltrate (chest X-ray or CT scan)
- Negative viral respiratory testing
- Treated for a minimum of 48 hours with antibiotics (excluding azithromycin due to its prolonged half-life)Presenting with an early clinical response within the last 24 hours (up to 7 days after the start of antibiotic...
- Patient presenting a clinical response within the last 24 hours defined by the presence of all the following criteria:
- apyrexia (T°C ≤ 37.8)
- heart rate \< 100/min
- respiratory rate \< 24/min, according to the patient's usual mode of oxygenation,
- arterial oxygen saturation ≥ 92%, according to the patient's usual mode of oxygenation,
- systolic blood pressure ≥ 90mmHg, The last occurring of these criteria must have appeared within the last 24 hours.
- The antibiotic treatment for suspected CAP has started at least 48 hours ago and at most 6 days ago
- No other site of infection besides respiratory
- Affiliated to Health insurance
- Has given informed consent
- Patient understanding oral and written French, or presence of a relative who can explain and help him complete the study documents
- Signs of severe CAP (abscess, massive pleural effusion, serious chronic respiratory insufficiency)
- Known immunosuppression (asplenia, neutropenia, agammaglobulinemia, transplant, myeloma, lymphoma, known HIV and CD4\<200/mm3)
- Suspected or confirmed legionellosis
- Any other infection necessitating concomitant antibiotic treatment
- Confirmed or suspected aspiration pneumonia or healthcare-associated pneumonia
- Treatment of suspected CAP with azithromycin (due to its prolonged half-life)
- Concomitant steroid treatment (only for patients treated with fluoroquinolones antibiotics)
- Pre-existing aortic aneurysm or dissection, family history of aortic aneurysm or dissection, Marfan syndrome, Ehlers-Danlos syndrome, Takayasu arthritis, uncontrolled arterial hypertension, atherosclerosis (only for...
- Pregnant or breastfeeding woman
- Life expectancy \< 1 month
- Patient under legal guardianship (French "tutelle" or "curatelle")
- Patient without fixed address
- Patient enrolled in another treatment clinical trial on CAP treatment
The study team makes the final eligibility decision.
Where it's taking place
- Garches, 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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Garches, France. 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.