Antibiotic Therapy In Respiratory Tract Infections

NCT04166110 | Unknown

• 2 other identifiers: P160929J2019-001873-10
• Study Type: interventional
• Target: 310
• Locations: 1 country
• Sites: 1

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. 1.Clinical success at late follow up (Day 30),
2. 2.Duration of antibiotic treatment,
3. 3.Frequency and severity of adverse events,
4. 4.Patient's pneumonia symptoms and quality of life.

Conditions

Community-Acquired Pneumonia

Keywords

community-acquired pneumonia; antibiotic therapy duration strategy; non-inferiority trial

Outcome Measures

Primary Outcomes (1)

• Cure rate at 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.

  Day 15

Secondary Outcomes (4)

• Cure rate at day 30

  Day 30

• 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

Study Arms (2)

Physician's prescription

ACTIVE COMPARATOR

Antibiotic treatment duration according to physician, following the French national guidelines: 7 to 14 days.

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.

Drug: Variable treatment duration

Interventions

Predetermined treatment duration DRUG

Antibiotic treatment duration left to the physician's judgement (following national guidelines, 7 to 14 days)

Physician's prescription

Variable treatment duration DRUG

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.

Duration according to stability

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Unité des Maladies Infectieuses, CHU Raymond Poincaré

Garches, Île-de-France Region, 92380, France

Location

MeSH Terms

Conditions

Community-Acquired Pneumonia

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases

Study Officials

• Aurélien DINH, MD

  Unité des Maladies Infectieuses, Hôpital Raymond Poincaré, Garches

  PRINCIPAL INVESTIGATOR

• Anne-Claude CRÉMIEUX, MD, PhD

  Service des maladies infectieuses, Hôpital Saint Louis, Paris

  STUDY DIRECTOR

Central Study Contacts

Aurélien DINH, MD

CONTACT

+ 33 1 47 10 44 32; aurelien.dinh@aphp.fr

Anne-Claude CRÉMIEUX, MD, PhD

CONTACT

+ 33 1 42 49 40 15; anne-claude.cremieux@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2019
• First Posted: November 18, 2019
• Study Start: September 1, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 23, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)