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Clinical Trials/EUCTR2019-001873-10-FR
EUCTR2019-001873-10-FR
Active, not recruiting
Phase 1

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

ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS0 sites310 target enrollmentJuly 19, 2019

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Community acquired pneumonia
Sponsor
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS
Enrollment
310
Status
Active, not recruiting
Last Updated
5 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
July 19, 2019
End Date
TBD
Last Updated
5 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Patient aged 18 years or more
  • Presenting with suspected CAP defined by all the followingthe presence of at least 2 of the following diagnostic clinical criteria:
  • \- Fever (temperature \> 38°C)
  • \- Dyspnea,
  • \- 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
  • Affiliated to Health insurance

Exclusion Criteria

  • 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 (heart rate \> 100/min)
  • Baseline oxygen saturation \< 90% or home oxygen therapy
  • More than 24 hours of antibiotic treatment prior to consultation
  • Any other infection necessitating antibiotic treatment
  • Breastfeeding
  • Life expectancy \< 1 month

Outcomes

Primary Outcomes

Not specified

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