Azithromycin+Amoxicillin/Clavulanate vs Amoxicillin/Clavulanate in COVID19 Patients With Pneumonia in Non-intensive Unit
- Conditions
- COVID-19 Pneumonia
- Interventions
- Drug: amoxicillin/clavulanateCombination Product: Azithromycin with amoxicillin/clavulanate
- Registration Number
- NCT04363060
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 104
- 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.
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Amoxicillin/clavulanate amoxicillin/clavulanate Amoxicillin/clavulanate every day during 7 days. Azithromycin with amoxicillin/clavulanate Azithromycin with amoxicillin/clavulanate Combination of azithromycin during 4 days with amoxicillin/clavulanate during 7 days.
- Primary Outcome Measures
Name Time Method Rate of positive SARS-CoV-2 RT-PCR Day 6 Rate of positive SARS-CoV-2 RT-PCR on nasopharyngeal sample
- Secondary Outcome Measures
Name Time Method Number of all-cause mortality during the 30 days following inclusion 30 days Number of all-cause mortality during the 30 days following inclusion
Number of in-hospital mortality during the 30 days following inclusion 30 days Number of in-hospital mortality during the 30 days following inclusion
Number of patients transferred to intensive care unit during the 30-day follow-up 30 days Number of patients transferred to intensive care unit during the 30-day follow-up
Number of days without mechanical ventilation during the 30 days following inclusion 30 days Number of days without mechanical ventilation during the 30 days following inclusion
Rate of positive SARS-CoV-2 RT-PCR Day 10 Rate of positive SARS-CoV-2 RT-PCR on nasopharyngeal sample
Clinical evolution on the World Health Organization Ordinal Scale for Clinical Improvement for COVID-19 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)
Total duration of antibiotic treatment during the 30 days following inclusion 30 days Total duration of antibiotic treatment during the 30 days following inclusion
adverse events attributable to antibiotic treatment during the 30 days following inclusion 30 days adverse events attributable to antibiotic treatment during the 30 days following inclusion
Hospital length of stay during the 30 days following inclusion 30 days Hospital length of stay during the 30 days following inclusion
Trial Locations
- Locations (3)
Chu Angers
🇫🇷Angers, France
CHU Poitiers
🇫🇷Poitiers, France
CHD Vendée
🇫🇷La Roche-sur-Yon, France