Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2026-02-25 @ 6:30 PM
Study NCT ID:
NCT01537250
Status:
COMPLETED
Last Update Posted:
2018-01-24
First Post:
2012-02-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase II Clinical Study to Assess the Efficacy and Safety of Nemonoxacin Malate in Treating Adult Patients With Community-acquired Pneumonia (CAP)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000098968', 'term': 'Community-Acquired Pneumonia'}], 'ancestors': [{'id': 'D017714', 'term': 'Community-Acquired Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D064704', 'term': 'Levofloxacin'}], 'ancestors': [{'id': 'D015242', 'term': 'Ofloxacin'}, {'id': 'D024841', 'term': 'Fluoroquinolones'}, {'id': 'D042462', 'term': '4-Quinolones'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 192}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-23', 'studyFirstSubmitDate': '2012-02-05', 'studyFirstSubmitQcDate': '2012-02-16', 'lastUpdatePostDateStruct': {'date': '2018-01-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-02-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Per subject clinical cure rate', 'timeFrame': '16days', 'description': "Clinical cure rate equals to number of clinical evaluable divided by number of clinical cured. If subject's clnical outcome is evaluable by principal invastigator, he/she is defined as clinical evaluable."}, {'measure': 'Per subject microbiological cure rate', 'timeFrame': '16days', 'description': 'Microbiological cure rate equals to number of microbiological evaluable divided by number of eradicated or presumed eradicated.'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetic profile of nemonoxacin in CAP subjects', 'timeFrame': '3days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['CAP'], 'conditions': ['Community-acquired Pneumonia']}, 'referencesModule': {'references': [{'pmid': '26748734', 'type': 'DERIVED', 'citation': 'Liu Y, Zhang Y, Wu J, Zhu D, Sun S, Zhao L, Wang X, Liu H, Ren Z, Wang C, Xiu Q, Xiao Z, Cao Z, Cui S, Yang H, Liang Y, Chen P, Lv Y, Hu C, Lv X, Liu S, Kuang J, Li J, Wang D, Chang L. A randomized, double-blind, multicenter Phase II study comparing the efficacy and safety of oral nemonoxacin with oral levofloxacin in the treatment of community-acquired pneumonia. J Microbiol Immunol Infect. 2017 Dec;50(6):811-820. doi: 10.1016/j.jmii.2015.09.005. Epub 2015 Dec 1.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety, tolerability and population pharmacokinetics of oral nemonoxacin in community-acquired pneumonia (CAP) subjects.', 'detailedDescription': 'Evaluate clinical efficacy, microbiological efficacy and safety of Nemonoxacin adult patients with community-acquired pneumonia (CAP); and\n\nA study on the population pharmacokinetics (PPK) of continuous oral administration of Nemonoxacin in adult patients with CAP.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. age of 18\\~70, BMI ≥ 18 kg/m2\n2. Female patients must avoid pregnancy\n3. Patients who are clinically diagnosed with community-acquired pneumonia (CAP)\n4. Chest X-ray shows inflammatory exudation or infiltration image.\n5. Patients who used antibacterial agents (excluding quinolones) within 72 hours before\n6. The patient's disease condition permits oral administration\n\nExclusion Criteria:\n\n1. Patients who have any of bronchiectasis and pulmonary disease.\n2. Hospitalized within 14 days before enrollment\n3. Have a history of allergy to any quinolone or fluoroquinolone antibiotic\n4. Patients who suffered uncontrolled mental disorders, epilepsy or central nervous system diseases.\n5. Renal, liver insufficiency\n6. Malabsorption syndrome or other gastrointestinal diseases\n7. Immune system diseases,such as a history of human immunodeficiency virus (HIV) infection,neutropenia or malignant tumor in the blood system or a solid organ, or removal of spleen\n8. Steroids longterm use, the dose is at least 20mg of prednisone daily\n9. Patients under critical condition.\n10. Shows significant abnormality of the cardiac conduction system (CCS) or other abnormalities, or prolonged QTc\n11. Have a medical history of prolonged QTc, or require concomitant medication of drugs that will lead to prolongation of QTc\n12. Patients who received chemotherapy or anti-tumor therapy within 6 months\n13. Alcohol abused or drugs banned\n14. Patients who used quinolones within two weeks before enrollment\n15. Donated more than 500ml of blood within 3 months\n16. co-medication of other antibacterial agents required.\n17. by investigators judgement,patient who increase the risk to the subjects or interfere with this clinical trial."}, 'identificationModule': {'nctId': 'NCT01537250', 'briefTitle': 'Phase II Clinical Study to Assess the Efficacy and Safety of Nemonoxacin Malate in Treating Adult Patients With Community-acquired Pneumonia (CAP)', 'organization': {'class': 'INDUSTRY', 'fullName': 'TaiGen Biotechnology Co., Ltd.'}, 'officialTitle': 'A Multi-center, Randomized, Double-blind, Double-dummy Parallel-controlled Phase II Clinical Study to Assess the Efficacy and Safety of Nemonoxacin Malate in Treating Adult Patients With Community-acquired Pneumonia (CAP)', 'orgStudyIdInfo': {'id': 'TG-873870-C-3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Nemonoxacin 750 mg', 'description': 'Nemonoxacin 750 mg 2 tablets.', 'interventionNames': ['Drug: Levofloxacin 500 mg placebol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Nemonoxacin 500 mg', 'description': 'Nemonoxacin 500 mg 3 tablets', 'interventionNames': ['Drug: Levofloxacin 500 mg placebol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Levofloxacin 500 mg', 'description': 'Levofloxacin 500 mg', 'interventionNames': ['Drug: Nemonoxacin 3 tablets']}], 'interventions': [{'name': 'Levofloxacin 500 mg placebol', 'type': 'DRUG', 'description': 'oral form,,once adily,7\\~10 days', 'armGroupLabels': ['Nemonoxacin 750 mg']}, {'name': 'Levofloxacin 500 mg placebol', 'type': 'DRUG', 'description': 'oral form,,once adily,7\\~10 days', 'armGroupLabels': ['Nemonoxacin 500 mg']}, {'name': 'Nemonoxacin 3 tablets', 'type': 'DRUG', 'description': 'oral form,once daily,7\\~10 days', 'armGroupLabels': ['Levofloxacin 500 mg']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'facility': 'Beijing Chaoyang Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'country': 'China', 'facility': 'Beijing Union Medical College Hospital, Chinese Academy of Medical Sciences', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'country': 'China', 'facility': 'Peking University First Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'country': 'China', 'facility': "Peking University People's Hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'country': 'China', 'facility': 'PLA Second Artillery General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'country': 'China', 'facility': 'Zhen Hospital, Capital Medical University Beijing', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Chongqing', 'country': 'China', 'facility': 'Daping Hospital, Third Military Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'city': 'Fujian', 'country': 'China', 'facility': 'First Affiliated Hospital of Fujian Medical University', 'geoPoint': {'lat': 28.92651, 'lon': 106.12972}}, {'city': 'Gansu', 'country': 'China', 'facility': "Gansu Provincial People's Hospital", 'geoPoint': {'lat': 23.72839, 'lon': 108.65543}}, {'city': 'Guangzhou', 'country': 'China', 'facility': 'Guangzhou Red Cross Hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Guangzhou', 'country': 'China', 'facility': 'Second Affiliated Hospital of Sun Yat-sen', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Guilin', 'country': 'China', 'facility': 'Affiliated Hospital of Guilin Medical College', 'geoPoint': {'lat': 25.28022, 'lon': 110.29639}}, {'city': 'Hubei', 'country': 'China', 'facility': 'Taihe Hospital in Shiyan City, Hubei Province', 'geoPoint': {'lat': 38.99842, 'lon': 112.01144}}, {'city': 'Hunan', 'country': 'China', 'facility': 'Third Xiangya Hospital, Central South University', 'geoPoint': {'lat': 28.71667, 'lon': 118.83333}}, {'city': 'Jiangxi', 'country': 'China', 'facility': "Jiangxi Provincial People's Hospital", 'geoPoint': {'lat': 33.99934, 'lon': 105.19994}}, {'city': 'Jiangxi', 'country': 'China', 'facility': 'Second Affiliated Hospital of Nanchang University', 'geoPoint': {'lat': 33.99934, 'lon': 105.19994}}, {'city': 'Jinan', 'country': 'China', 'facility': 'Jinan Central Hospital', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'city': 'Liaoning', 'country': 'China', 'facility': 'Shengjing Hospital of China Medical University'}, {'city': 'Nanjing', 'country': 'China', 'facility': 'Nanjing General Hospital of Nanjing Military Region', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'city': 'Shanghai', 'country': 'China', 'facility': 'Huashan Hospital ,Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'country': 'China', 'facility': 'Institute of Antibiotics, Huashan Hospital, Fundan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'country': 'China', 'facility': 'Institute of Antibiotics,Huashan Hospital ,Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'country': 'China', 'facility': 'Shanghai Pudong New Area, Oriental Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'country': 'China', 'facility': 'Shanghai Putuo District Central Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanxi', 'country': 'China', 'facility': 'First Hospital of Shanxi Medical University', 'geoPoint': {'lat': 44.00313, 'lon': 126.21057}}, {'city': 'Shenyang', 'country': 'China', 'facility': "People's Liberation Army General Hospital of Shenyang Military Region", 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'city': 'Shenzhen', 'country': 'China', 'facility': "Shenzhen People's Hospital", 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}, {'city': 'Sichuan', 'country': 'China', 'facility': 'West China Hospital of Sichuan University (Respiratory)', 'geoPoint': {'lat': 35.1221, 'lon': 105.48032}}, {'city': 'Wenzhou', 'country': 'China', 'facility': 'Second Affiliated Hospital of Wenzhou Medical College', 'geoPoint': {'lat': 27.99942, 'lon': 120.66682}}, {'city': 'Wuhan', 'country': 'China', 'facility': "People's Hospital of Wuhan University", 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': 'Wuhan', 'country': 'China', 'facility': 'Wuhan General Hospital of PLA Guangzhou Military Region', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': 'Zhejiang', 'country': 'China', 'facility': 'First Affiliated Hospital, Zhejiang University School of Medicine', 'geoPoint': {'lat': 25.3238, 'lon': 105.583}}], 'overallOfficials': [{'name': 'Yingyuan Zhang, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Huashan Hospital, Fundan University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TaiGen Biotechnology Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}