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Antibiotic Therapy In Respiratory Tract Infections (AIR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04166110
Recruitment Status : Not yet recruiting
First Posted : November 18, 2019
Last Update Posted : November 18, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment Phase
Community-Acquired Pneumonia Drug: Predetermined treatment duration Drug: Variable treatment duration Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 310 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : November 2019
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Physician's prescription
Antibiotic treatment duration according to physician, following the French national guidelines: 7 to 14 days.
Drug: Predetermined treatment duration
Antibiotic treatment duration left to the physician's judgement (following national guidelines, 7 to 14 days)

Experimental: Duration according to stability

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.

Drug: Variable 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.





Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. Cure rate at day 30 [ Time Frame: 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.

  2. Duration of antibiotic treatment [ Time Frame: Up to 14 days ]
  3. Frequency and severity of adverse events [ Time Frame: through study completion, an average of 30 days ]
  4. Evolution of pneumonia symptoms [ Time Frame: 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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04166110


Contacts
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Contact: Aurélien DINH, MD + 33 1 47 10 44 32 aurelien.dinh@aphp.fr
Contact: Anne-Claude CRÉMIEUX, MD, PhD + 33 1 42 49 40 15 anne-claude.cremieux@aphp.fr

Locations
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France
Unité des Maladies Infectieuses, CHU Raymond Poincaré
Garches, Île-de-France, France, 92380
Contact: Aurélien DINH, MD    + 33 1 47 10 44 32    aurelien.dinh@aphp.fr   
Contact: Anne-Claude CRÉMIEUX, MD, PhD    + 33 1 42 49 40 15    anne-claude.cremieux@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Aurélien DINH, MD Unité des Maladies Infectieuses, Hôpital Raymond Poincaré, Garches
Study Director: Anne-Claude CRÉMIEUX, MD, PhD Service des maladies infectieuses, Hôpital Saint Louis, Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04166110    
Other Study ID Numbers: AOM16618
First Posted: November 18, 2019    Key Record Dates
Last Update Posted: November 18, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
community-acquired pneumonia
antibiotic therapy duration strategy
non-inferiority trial
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents