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AIR. ANTIBIOTIC THERAPY IN RESPIRATORY TRACT INFECTIONS A controlled randomized, open label, multicenter, non-inferiority trial evaluating an individualized antibiotic treatment duration based on patient clinical response, evaluated through connected devices, for suspected community acquired pneumonia in the community setting

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-516097-30-00
Acronym
P160929J
Enrollment
500
Registered
2024-11-13
Start date
Unknown
Completion date
Unknown
Last updated
2024-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Community acquired pneumonia (CAP)

Brief summary

Percentage of cure at Day 15 after the start of treatment

Detailed description

Percentage of cure at Day 30, Duration of antibiotic treatment, Frequency and severity of adverse events between the 2 study arms, Patients' evolution of pneumonia symptoms and quality of life between the 2 study arms, A composite endpoint defined by the observation of one of the events characterizing the response to antibiotic treatment, among: clinical failure or; microbiological failure or; emergence of antibiotic resistance, Time to clinical recovery (regardless of microbiological recovery or resistance failure), Presence or absence of antimicrobial resistance at any point during follow-up, Association between specific antibiotics and respiratory microbiome evolution, Association between specific antibiotics and gut microbiome evolution, Duration of antimicrobial treatment

Interventions

DRUGAMPICILLIN
DRUGMOXIFLOXACIN
DRUGAZITHROMYCIN
DRUGLEVOFLOXACIN
DRUGAMOXICILLIN
DRUGERYTHROMYCIN
DRUGCIPROFLOXACIN
DRUGCLARITHROMYCIN

Sponsors

Assistance Publique Hopitaux De Paris
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Percentage of cure at Day 15 after the start of treatment

Secondary

MeasureTime frame
Percentage of cure at Day 30, Duration of antibiotic treatment, Frequency and severity of adverse events between the 2 study arms, Patients' evolution of pneumonia symptoms and quality of life between the 2 study arms, A composite endpoint defined by the observation of one of the events characterizing the response to antibiotic treatment, among: clinical failure or; microbiological failure or; emergence of antibiotic resistance, Time to clinical recovery (regardless of microbiological recovery or resistance failure), Presence or absence of antimicrobial resistance at any point during follow-up, Association between specific antibiotics and respiratory microbiome evolution, Association between specific antibiotics and gut microbiome evolution, Duration of antimicrobial treatment

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026