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

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: NCT04363060
Recruitment Status : Not yet recruiting
First Posted : April 27, 2020
Last Update Posted : April 29, 2020
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

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 worldwide.1 As of April 14, 2020, there have been more than 1.5 million reported cases and 124 000 deaths in more than 200 countries. A recent open-label nonrandomized French study reporte that addition of azithromycin to hydroxychloroquine in 6 patients resulted in numerically superior viral clearance (6/6, 100%) compared with hydroxychloroquine monotherapy (8/14, 57%) or control (2/16, 12.5%). Azithromycin alone has never been tested, whereas azithromycin has immunomodulating and anti-inflammatory properties that could theoretically prevent or limit secondary worsening. Our hypothesis is that azithromycin combined with amoxicillin/clavulanate will be superior to amoxicillin/clavulanate alone to obtain viral clearance at Day 6 in COVID-19 patients with pneumonia and hospitalized in a non-intensive care unit ward.

Condition or disease Intervention/treatment Phase
COVID-19 Pneumonia Combination Product: Azithromycin with amoxicillin/clavulanate Drug: amoxicillin/clavulanate Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Azithromycin With Amoxicillin/Clavulanate Versus Amoxicillin/Clavulanate Alone in COVID-19 Patients With Pneumonia and Hospitalized in a Non-intensive Care Unit Ward (AziA): a Superiority Open-label Randomized Controlled Trial
Estimated Study Start Date : April 30, 2020
Estimated Primary Completion Date : July 30, 2020
Estimated Study Completion Date : July 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
Experimental: Azithromycin with amoxicillin/clavulanate
Combination of azithromycin during 4 days with amoxicillin/clavulanate during 7 days.
Combination Product: Azithromycin with amoxicillin/clavulanate
Patients will receive azithromycin 500 mg on day 1 followed by 250mg per day for the next four days with amoxicillin/clavulanate 1 gr 3 times per day during 7 days. In case of allergy, amoxicillin/clavulanate can be replaced by a third-generation cephalosporin

Active Comparator: Amoxicillin/clavulanate
Amoxicillin/clavulanate every day during 7 days.
Drug: amoxicillin/clavulanate
Patients will receive amoxicillin/clavulanate 1 gr 3 times per day during 7 days. In case of allergy, amoxicillin/clavulanate can be replaced by a third-generation cephalosporin




Primary Outcome Measures :
  1. Rate of positive SARS-CoV-2 RT-PCR [ Time Frame: Day 6 ]
    Rate of positive SARS-CoV-2 RT-PCR on nasopharyngeal sample


Secondary Outcome Measures :
  1. Rate of positive SARS-CoV-2 RT-PCR [ Time Frame: Day 10 ]
    Rate of positive SARS-CoV-2 RT-PCR on nasopharyngeal sample

  2. Clinical evolution on the World Health Organization Ordinal Scale for Clinical Improvement for COVID-19 [ Time Frame: day 6, day 10, and day 30 ]
    Clinical evolution on the WHO Ordinal Scale for Clinical Improvement for COVID-19 score. Scale ranging from 0 to 8 (0:unifected; 8:dead)

  3. Total duration of antibiotic treatment during the 30 days following inclusion [ Time Frame: 30 days ]
    Total duration of antibiotic treatment during the 30 days following inclusion

  4. Number of all-cause mortality during the 30 days following inclusion [ Time Frame: 30 days ]
    Number of all-cause mortality during the 30 days following inclusion

  5. Number of in-hospital mortality during the 30 days following inclusion [ Time Frame: 30 days ]
    Number of in-hospital mortality during the 30 days following inclusion

  6. Number of patients transferred to intensive care unit during the 30-day follow-up [ Time Frame: 30 days ]
    Number of patients transferred to intensive care unit during the 30-day follow-up

  7. Number of days without mechanical ventilation during the 30 days following inclusion [ Time Frame: 30 days ]
    Number of days without mechanical ventilation during the 30 days following inclusion

  8. adverse events attributable to antibiotic treatment during the 30 days following inclusion [ Time Frame: 30 days ]
    adverse events attributable to antibiotic treatment during the 30 days following inclusion

  9. Hospital length of stay during the 30 days following inclusion [ Time Frame: 30 days ]
    Hospital length of stay during the 30 days following inclusion



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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)

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): NCT04363060


Contacts
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Contact: Emmanuel MONTASSIER +33 (0)2 53 48 20 38 Emmanuel.montassier@chu-nantes.fr

Locations
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France
Chu Angers
Angers, France
Contact: Vincent DUBEE, MD, PhD         
CHD Vendée
La Roche-sur-Yon, France
Contact: Romain DECOURS, MD, PhD         
CHU Poitiers
Poitiers, France
Contact: Blandine RAMMAERT, MD, PhD         
Sponsors and Collaborators
Nantes University Hospital
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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT04363060    
Other Study ID Numbers: RC20_0168
First Posted: April 27, 2020    Key Record Dates
Last Update Posted: April 29, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Amoxicillin
Azithromycin
Clavulanic Acid
Clavulanic Acids
Amoxicillin-Potassium Clavulanate Combination
Anti-Bacterial Agents
Anti-Infective Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action