Customized Antibiotic Treatment Duration Among Hospitalized Patients With Moderately Severe Community-Acquired Pneumonia

Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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. * To compare between the 2 study arms at Day 30 of antibiotic treatment: * The duration of antibiotic treatment; * The length of hospital stay; * The frequency and severity of adverse events during the 30 days after the start of treatment. * To explore the impact of reduced antibiotic treatment duration for CAP on the oropharyngeal resistome.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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 treatment, if planned treatment duration \> 7 days), defined by the presence of all the following criteria:apyrexia (T°C ≤ 37.8)heart rate \< 100/minrespiratory 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,Patient currently under antibiotic treatment for his suspected CAP (i.e. the last dose of ATB has been administered to the patient less than 24 hours ago)

• 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

Locations
Other Locations
France
Infectious diseases department, Raymond-Poincaré Hospital - APHP
RECRUITING
Garches
Contact Information
Primary
Aurélien Dinh, MD, PhD
aurelien.dinh@aphp.fr
+ 33 (0)1 47 10 44 32
Backup
Jacques Ropers, PharmD
jacques.ropers@aphp.fr
+ 33 01 42 16 03 48
Time Frame
Start Date: 2024-02-05
Estimated Completion Date: 2027-05
Participants
Target number of participants: 328
Treatments
Placebo_comparator: Antibiotic treatment
Antibiotic treatment duration left to the physician's judgment (usual practice: total treatment duration between 5 to 10 days according to French guidelines; more than 7 days of treatment should be justified).
Experimental: Interruption of treatment
Interruption of treatment based on the patient reaching all of the following stability criteria (body temperature ≤ 37.8°C; heart rate ≤ 100/min; systolic blood pressure \> 90mmHg; oxygen saturation ≥ 92%; respiratory rate \< 24/min; normal mental status (27)), with a treatment duration no shorter than 48 h.
Related Therapeutic Areas
Sponsors
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov