Community-Acquired Pneumonia
Conditions
Keywords
community-acquired pneumonia, antibiotic therapy duration strategy, non-inferiority trial
Brief summary
Primary aim: to demonstrate that stopping antibiotic treatment in patients diagnosed with acute community acquired pneumonia (CAP) based on clinical response has a non-inferior efficacy 15 days after start of treatment, compared to a conventional predetermined duration left to the physician's judgement, in adults treated in the community setting. Secondary aims: To compare the 2 study arms on: 1. Clinical success at late follow up (Day 30), 2. Duration of antibiotic treatment, 3. Frequency and severity of adverse events, 4. Patient's pneumonia symptoms and quality of life.
Detailed description
Recent studies have suggested that CAP can be successfully treated by short-course antibiotic regimen when clinical improvement is rapidly obtained. Even if clinical response is obtained in 3 days in the majority of cases, it can widely vary among patients, suggesting that one duration does not fit all. An individualized duration of therapy depending on the patient's response could help to ensure bacterial eradication while avoiding unnecessary antibiotic exposure and thus reduce antibiotic resistance. At present, this strategy has never been tested. This is a pragmatic open label non-inferiority randomized multicenter trial with two parallel arms comparing antibiotic treatment duration left to the physician's judgement (usually 7 to 14 days), versus interruption of treatment based on the patient's clinical response defined by reaching stability criteria (body temperature ≤ 37.8°C; heart rate ≤ 100/min; systolic blood pressure ≥ 90mmHg, oxygen saturation ≥ 90%) for 24h, after a minimum of 2 days treatment. Recruitment and follow-up: Outpatients consulting in a private multiprofessional health center, diagnosed as having CAP and in need for antibiotics will be assessed for eligibility. Following information and signing consent, eligible patients will be included in the study. They will receive the prescription (antibiotic type and duration determined by the physician, preferably chosen according to the French guidelines) and a collection of connected devices to monitor their vital signs 2 times a day (morning and evening). Preselected patients will be randomized as soon as they meet the two following criteria: i) they have presented the stability criteria for 24h (3 consecutive vital signs recordings); ii) they have started the antibiotic treatment at least 72 hours before, with a ≥ 80% compliance, and with at least 1 intake in the last 24 hours. Each patient will then receive a telephone call from the coordinating team (or a permanent medical platform at nights, during weekends or public holidays) in order to proceed to the randomization and ensure that everything is well understood by the patient as well as the security and compliance with the strategy. A follow-up visit with the investigator will be performed at day 15 after the start of antibiotic treatment. The final evaluation will be performed 30 days following the start of antibiotic treatment by a telephone call from the coordinating team. Number of subjects necessary: 310 patients.
Interventions
DRUGPredetermined treatment duration
Antibiotic treatment duration left to the physician's judgement (following national guidelines, 7 to 14 days)
DRUGVariable treatment duration
Treatment duration vary according to stability criteria reaching time Patients will self-monitor 2 times a day (in the morning and in the evening) using a set of connected devices, to monitor their vital signs before any treatment intake. After at least 3 days of treatment and stability criteria obtained for the last 24 hours (i.e. 3 vital signs recording), patients will stop the antibiotic treatment.
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient aged 18 years or more * Has given written informed consent * Affiliated to Health insurance * Is able to take oral treatment * Presenting with suspected CAP defined by the presence of at least 2 of the following diagnostic clinical criteria: * Fever (temperature \> 38°C) * Dyspnea * Cough * Production of purulent sputum * Crackles * Radiological evidence of a new infiltrate (on chest X-ray or CT scan) * In need for antibiotic treatment targeting respiratory tract, according to the physician in charge * No other site of infection besides respiratory
Exclusion criteria
All subjects meeting any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cure rate at day 15 | Day 15 | Cure rate is the number of patients who are cured, as defined by the association of 3 criteria : 1. stability: body temperature ≤ 37.8°C; heart rate ≤ 100/min; systolic blood pressure \> 90mmHg and oxygen saturation ≥ 90%. 2. absence of: incidence of coughing, sputum production, shortness of breath and crackles. 3. absence of additional antibiotic taken after the end of initial antibiotic treatment. Clinical evaluation at Day 14 or Day 16 is allowed to take into account. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cure rate at day 30 | Day 30 | Cure rate is the number of patients who are cured, as defined by the association of 2 criteria: 1. absence of: incidence of coughing, sputum production, shortness of breath and crackles. 2. absence of additional antibiotic taken after the end of initial antibiotic treatment. |
| Duration of antibiotic treatment | Up to 14 days | — |
| Frequency and severity of adverse events | through study completion, an average of 30 days | — |
| Evolution of pneumonia symptoms | through study completion, an average of 30 days | Patients' evolution of pneumonia symptoms and quality of life between the 2 study arms (CAP Score / CAP Sym) |
Countries
France
Contacts
Primary ContactAurélien DINH, MD
Backup ContactAnne-Claude CRÉMIEUX, MD, PhD
Outcome results
None listed