Status:

UNKNOWN

Azithromycin+Amoxicillin/Clavulanate vs Amoxicillin/Clavulanate in COVID19 Patients With Pneumonia in Non-intensive Unit

Lead Sponsor:

Nantes University Hospital

Conditions:

COVID-19 Pneumonia

Eligibility:

All Genders

18-99 years

Phase:

PHASE3

Brief Summary

The global pandemic of novel coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) began in Wuhan, China, in December 2019, and has since spread wo...

Eligibility Criteria

Inclusion

  • Adult ≥ 18 ans,
  • Patient with positive SARS-CoV-2 RT-PCR on nasopharyngeal sample at randomization or within the previous 48 hours,
  • Patient with pneumonia diagnosed by thorax CT-scan or echography,
  • Patient able to take per os medication,
  • Written and signed consent of the patient,
  • Patients affiliated with or benefitting from a social security scheme.

Exclusion

  • Patient hospitalized in intensive care unit,
  • Patient who received more than 24 hours of antibiotic treatment for the ongoing episode,
  • Chronic renal failure with a Glomerular Filtration Rate \< 20ml/min,
  • Severe hepatic failure,
  • Severe chronic cardiac insufficiency,
  • Allergy to macrolides,
  • Electrocardiogram showing corrected QT prolongation greater than 470 ms in men and 480 ms in women.
  • Life-threatening presentation expected to lead to possible imminent death (based on provider assessment)

Key Trial Info

Start Date :

April 30 2020

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

July 30 2020

Estimated Enrollment :

104 Patients enrolled

Trial Details

Trial ID

NCT04363060

Start Date

April 30 2020

End Date

July 30 2020

Last Update

April 29 2020

Active Locations (3)

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Page 1 of 1 (3 locations)

1

Chu Angers

Angers, France

2

CHD Vendée

La Roche-sur-Yon, France

3

CHU Poitiers

Poitiers, France