Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-26 @ 4:49 AM
Study NCT ID:
NCT04363060
Status:
UNKNOWN
Last Update Posted:
2020-04-29
First Post:
2020-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Azithromycin+Amoxicillin/Clavulanate vs Amoxicillin/Clavulanate in COVID19 Patients With Pneumonia in Non-intensive Unit
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017963', 'term': 'Azithromycin'}, {'id': 'D000658', 'term': 'Amoxicillin'}, {'id': 'D019818', 'term': 'Clavulanic Acid'}, {'id': 'D019980', 'term': 'Amoxicillin-Potassium Clavulanate Combination'}], 'ancestors': [{'id': 'D004917', 'term': 'Erythromycin'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000667', 'term': 'Ampicillin'}, {'id': 'D010400', 'term': 'Penicillin G'}, {'id': 'D010406', 'term': 'Penicillins'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D002969', 'term': 'Clavulanic Acids'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 104}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-04-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-04-27', 'studyFirstSubmitDate': '2020-04-23', 'studyFirstSubmitQcDate': '2020-04-23', 'lastUpdatePostDateStruct': {'date': '2020-04-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of positive SARS-CoV-2 RT-PCR', 'timeFrame': 'Day 6', 'description': 'Rate of positive SARS-CoV-2 RT-PCR on nasopharyngeal sample'}], 'secondaryOutcomes': [{'measure': 'Rate of positive SARS-CoV-2 RT-PCR', 'timeFrame': 'Day 10', 'description': 'Rate of positive SARS-CoV-2 RT-PCR on nasopharyngeal sample'}, {'measure': 'Clinical evolution on the World Health Organization Ordinal Scale for Clinical Improvement for COVID-19', 'timeFrame': 'day 6, day 10, and day 30', 'description': 'Clinical evolution on the WHO Ordinal Scale for Clinical Improvement for COVID-19 score. Scale ranging from 0 to 8 (0:unifected; 8:dead)'}, {'measure': 'Total duration of antibiotic treatment during the 30 days following inclusion', 'timeFrame': '30 days', 'description': 'Total duration of antibiotic treatment during the 30 days following inclusion'}, {'measure': 'Number of all-cause mortality during the 30 days following inclusion', 'timeFrame': '30 days', 'description': 'Number of all-cause mortality during the 30 days following inclusion'}, {'measure': 'Number of in-hospital mortality during the 30 days following inclusion', 'timeFrame': '30 days', 'description': 'Number of in-hospital mortality during the 30 days following inclusion'}, {'measure': 'Number of patients transferred to intensive care unit during the 30-day follow-up', 'timeFrame': '30 days', 'description': 'Number of patients transferred to intensive care unit during the 30-day follow-up'}, {'measure': 'Number of days without mechanical ventilation during the 30 days following inclusion', 'timeFrame': '30 days', 'description': 'Number of days without mechanical ventilation during the 30 days following inclusion'}, {'measure': 'adverse events attributable to antibiotic treatment during the 30 days following inclusion', 'timeFrame': '30 days', 'description': 'adverse events attributable to antibiotic treatment during the 30 days following inclusion'}, {'measure': 'Hospital length of stay during the 30 days following inclusion', 'timeFrame': '30 days', 'description': 'Hospital length of stay during the 30 days following inclusion'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19 Pneumonia']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult ≥ 18 ans,\n* Patient with positive SARS-CoV-2 RT-PCR on nasopharyngeal sample at randomization or within the previous 48 hours,\n* Patient with pneumonia diagnosed by thorax CT-scan or echography,\n* Patient able to take per os medication,\n* Written and signed consent of the patient,\n* Patients affiliated with or benefitting from a social security scheme.\n\nExclusion Criteria:\n\n* Patient hospitalized in intensive care unit,\n* Patient who received more than 24 hours of antibiotic treatment for the ongoing episode,\n* Chronic renal failure with a Glomerular Filtration Rate \\< 20ml/min,\n* Severe hepatic failure,\n* Severe chronic cardiac insufficiency,\n* Allergy to macrolides,\n* Electrocardiogram showing corrected QT prolongation greater than 470 ms in men and 480 ms in women.\n* Life-threatening presentation expected to lead to possible imminent death (based on provider assessment)'}, 'identificationModule': {'nctId': 'NCT04363060', 'acronym': 'AziA', 'briefTitle': 'Azithromycin+Amoxicillin/Clavulanate vs Amoxicillin/Clavulanate in COVID19 Patients With Pneumonia in Non-intensive Unit', 'organization': {'class': 'OTHER', 'fullName': 'Nantes University Hospital'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'RC20_0168'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Azithromycin with amoxicillin/clavulanate', 'description': 'Combination of azithromycin during 4 days with amoxicillin/clavulanate during 7 days.', 'interventionNames': ['Combination Product: Azithromycin with amoxicillin/clavulanate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Amoxicillin/clavulanate', 'description': 'Amoxicillin/clavulanate every day during 7 days.', 'interventionNames': ['Drug: amoxicillin/clavulanate']}], 'interventions': [{'name': 'Azithromycin with amoxicillin/clavulanate', 'type': 'COMBINATION_PRODUCT', 'description': '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', 'armGroupLabels': ['Azithromycin with amoxicillin/clavulanate']}, {'name': 'amoxicillin/clavulanate', 'type': 'DRUG', 'description': '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', 'armGroupLabels': ['Amoxicillin/clavulanate']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Angers', 'country': 'France', 'contacts': [{'name': 'Vincent DUBEE, MD, PhD', 'role': 'CONTACT'}], 'facility': 'Chu Angers', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'city': 'La Roche-sur-Yon', 'country': 'France', 'contacts': [{'name': 'Romain DECOURS, MD, PhD', 'role': 'CONTACT'}], 'facility': 'CHD Vendée', 'geoPoint': {'lat': 46.66974, 'lon': -1.42757}}, {'city': 'Poitiers', 'country': 'France', 'contacts': [{'name': 'Blandine RAMMAERT, MD, PhD', 'role': 'CONTACT'}], 'facility': 'CHU Poitiers', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}], 'centralContacts': [{'name': 'Emmanuel MONTASSIER', 'role': 'CONTACT', 'email': 'Emmanuel.montassier@chu-nantes.fr', 'phone': '+33 (0)2 53 48 20 38'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nantes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}