Community-Acquired PneumoniaAIRNCT04166110
Antibiotic Therapy In Respiratory Tract Infections
A study testing Predetermined treatment duration and Variable treatment duration in people with Community-Acquired Pneumonia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Community-Acquired Pneumonia
- What is being tested?
- Predetermined treatment duration and Variable treatment duration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 310 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2023to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- All subjects meeting any of the following exclusion criteria at baseline will be excluded from study participation:
- Signs of severe CAP (abscess, massive pleural effusion, serious chronic respiratory insufficiency)
- Hospitalization following consultation
- Known immunosuppression (asplenia, neutropenia, agammaglobulinemia, immunosuppressive treatments or corticosteroids (prednisolone equivalent) > 10 mg/day, transplant, myeloma, lymphoma, known HIV and CD4<400/mm3, sickle-cell disease, Child-Pugh class C cirrhosis)
- Suspected or confirmed legionellosis
- Atrial fibrillation / constitutive tachycardia
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- Baseline oxygen saturation < 90% or home oxygen therapy
- More than 24 hours of antibiotics prior to consultation
- Any other infection necessitating concomitant antibiotic treatment
- Contraindications to the study antibiotics
- 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, arterial hypertension, atherosclerosis only for patients treated with fluoroquinolones antibiotics
- Pregnancy
- Breastfeeding
- Life expectancy < 1 month
- Patient under legal guardianship or without healthcare coverage
- Homeless patient
- Patient enrolled in another interventional clinical trial.
Trial locations and contacts
1 site in 1 country.
France1 site
Unité des Maladies Infectieuses, CHU Raymond Poincaré
Garches, Île-de-France Region, 92380
Aurélien DINH, MD, + 33 1 47 10 44 32, aurelien.dinh@aphp.fr
Anne-Claude CRÉMIEUX, MD, PhD, + 33 1 42 49 40 15, anne-claude.cremieux@aphp.fr
About this study
Official title: A Controlled Randomized, Open Label, Multicenter, Non-inferiority Trial Evaluating an Individualized Antibiotic Duration Treatment Based on Patient Clinical Response, Evaluated Through Connected Devices, for Community Acquired Pneumonia in the Community Setting
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:
- Clinical success at late follow up (Day 30),
- Duration of antibiotic treatment,
- Frequency and severity of adverse events,
- Patient's pneumonia symptoms and quality of life.
Read the 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.
- Conditions
- Community-Acquired Pneumonia
- Being tested
- Predetermined treatment duration, Variable treatment duration
- Keywords
- community-acquired pneumonia, antibiotic therapy duration strategy, non-inferiority trial
- 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.
Predetermined treatment durationDrug
Antibiotic treatment duration left to the physician's judgement (following national guidelines, 7 to 14 days)
Variable treatment durationDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Physician's prescription | Active comparator | Antibiotic treatment duration according to physician, following the French national guidelines: 7 to 14 days. Receives: Drug: Predetermined treatment duration |
| Duration according to stability | Experimental | Antibiotic treatment duration is variable. Interruption of treatment is based on the patient reaching stability criteria (body temperature ≤ 37.8°C; heart rate ≤ 100/min; systolic blood pressure ≥ 90mmHg, oxygen saturation ≥ 90%).
Minimum of duration of antibiotic treatment: 3 days. Receives: Drug: Variable treatment duration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cure rate at day 15
Cure rate is the number of patients who are cured, as defined by the association of 3 criteria :
- stability: body temperature ≤ 37.8°C; heart rate ≤ 100/min; systolic blood pressure > 90mmHg and oxygen saturation ≥ 90%.
- absence of: incidence of coughing, sputum production, shortness of breath and crackles.
- 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.
Measured: Day 15
Secondary outcomes (4)
Cure rate at day 30
Cure rate is the number of patients who are cured, as defined by the association of 2 criteria:
- absence of: incidence of coughing, sputum production, shortness of breath and crackles.
- absence of additional antibiotic taken after the end of initial antibiotic treatment.
Measured: Day 30
Duration of antibiotic treatment
Measured: Up to 14 days
Frequency and severity of adverse events
Measured: through study completion, an average of 30 days
Evolution of pneumonia symptoms
Patients' evolution of pneumonia symptoms and quality of life between the 2 study arms (CAP Score / CAP Sym)
Measured: through study completion, an average of 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2019
- Study startSep 2023 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (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 Assistance Publique - Hôpitaux de ParisThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 310 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aurélien DINH, MD, Principal investigator, Unité des Maladies Infectieuses, Hôpital Raymond Poincaré, GarchesAnne-Claude CRÉMIEUX, MD, PhD, Study director, Service des maladies infectieuses, Hôpital Saint Louis, Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04166110
- Sponsor's protocol ID
- P160929J
- Other IDs
- 2019-001873-10, 2019
- Acronym
- AIR
- Status last verified
- May 2023
- First submitted
- 30 Sep 2019
- Last updated
- 23 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Controlled Randomized, Open Label, Multicenter, Non-inferiority Trial Evaluating an Individualized Antibiotic Duration Treatment Based on Patient Clinical Response, Evaluated Through Connected Devices, for Community Acquired Pneumonia in the Community Setting
- ClinicalTrials.gov ID
- NCT04166110
- Acronym / sponsor ID
- AIR / P160929J
- Conditions
- Community-Acquired Pneumonia
- Keywords
- community-acquired pneumonia, antibiotic therapy duration strategy, non-inferiority trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 310 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Sep 2023 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 18 Nov 2019 (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.
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:
- Clinical success at late follow up (Day 30),
- Duration of antibiotic treatment,
- Frequency and severity of adverse events,
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physician's prescription | Active comparator | Drug: Predetermined treatment durationAntibiotic treatment duration according to physician, following the French national guidelines: 7 to 14 days. |
| Duration according to stability | Experimental | Drug: Variable treatment durationAntibiotic treatment duration is variable. Interruption of treatment is based on the patient reaching stability criteria (body temperature ≤ 37.8°C; heart rate ≤ 100/min; systolic blood pressure ≥ 90mmHg, oxygen saturation ≥ 90%). Minimum of duration of antibiotic treatment: 3 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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:
Key exclusion criteria (18 listed)
- All subjects meeting any of the following exclusion criteria at baseline will be excluded from study participation:
- Signs of severe CAP (abscess, massive pleural effusion, serious chronic respiratory insufficiency)
- Hospitalization following consultation
- Known immunosuppression (asplenia, neutropenia, agammaglobulinemia, immunosuppressive treatments or corticosteroids (prednisolone equivalent) > 10 mg/day, transplant, myeloma, lymphoma, known HIV and CD4<400/mm3, sickle-cell disease, Child-Pugh class C cirrhosis)
- Suspected or confirmed legionellosis
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 |
|---|---|---|
| Predetermined treatment durationAntibiotic treatment duration left to the physician's judgement (following national guidelines, 7 to 14 days) | Drug | Physician's prescription |
| Variable treatment durationTreatment 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. | Drug | Duration according to stability |
Primary outcome
Cure rate at day 15
Time frame: 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.
4 secondary outcomes
Cure rate at day 30
Time frame: Day 30
Duration of antibiotic treatment
Time frame: Up to 14 days
Frequency and severity of adverse events
Time frame: through study completion, an average of 30 days
Evolution of pneumonia symptoms
Time frame: through study completion, an average of 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Aurélien DINH, MD principal investigator
Unité des Maladies Infectieuses, Hôpital Raymond Poincaré, Garches
Anne-Claude CRÉMIEUX, MD, PhD study director
Service des maladies infectieuses, Hôpital Saint Louis, Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Predetermined treatment duration and Variable treatment duration in people with Community-Acquired Pneumonia, run by Assistance Publique - Hôpitaux de Paris at 1 site 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 13 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 23 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aurélien DINH, MD (+ 33 1 47 10 44 32, aurelien.dinh@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cure rate at day 15 (time frame: Day 15). 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 23 May 2023.