Ignite Creation Date:
2025-12-25 @ 5:02 AM
Ignite Modification Date:
2026-03-03 @ 12:10 PM
Study NCT ID:
NCT02913118
Status:
UNKNOWN
Last Update Posted:
2018-04-10
First Post:
2016-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adjunctive Therapy of Andrographolid Sulfonatein Community Acquired Pneumonia
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': 'D002511', 'term': 'Cephalosporins'}, {'id': 'D017963', 'term': 'Azithromycin'}, {'id': 'D008911', 'term': 'Minocycline'}, {'id': 'D004318', 'term': 'Doxycycline'}, {'id': 'D024841', 'term': 'Fluoroquinolones'}], 'ancestors': [{'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013843', 'term': 'Thiazines'}, {'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': 'D004917', 'term': 'Erythromycin'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D013754', 'term': 'Tetracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D042462', 'term': '4-Quinolones'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 462}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2019-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-04-09', 'studyFirstSubmitDate': '2016-09-12', 'studyFirstSubmitQcDate': '2016-09-21', 'lastUpdatePostDateStruct': {'date': '2018-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'time to clinical stability', 'timeFrame': '14 days'}, {'measure': 'number of study participants with treatment-related adverse events as assessed by CTCAE v4.0', 'timeFrame': '14 days', 'description': 'symptoms and signs, blood and urine routine, liver and kidney function monitoring, ECG, side effects of long-time using of antibiotics'}], 'secondaryOutcomes': [{'measure': 'the duration of fever', 'timeFrame': '14 days'}, {'measure': 'the initial treatment failure rate', 'timeFrame': '14 days'}, {'measure': 'length of stay in hospital', 'timeFrame': '14 days'}, {'measure': 'questionnaire for hospitalization expenses', 'timeFrame': '14 days'}, {'measure': 'the duration of intravenous antibiotic treatment', 'timeFrame': '14 days'}, {'measure': 'the rate of diarrhea and intestinal dysbacteriosis', 'timeFrame': '14 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Community Acquired Pneumonia']}, 'descriptionModule': {'briefSummary': 'Adjunctive Therapy of AndrographolidSulfonate in Community Acquired Pneumonia: A Multicenter, Randomized,Double-blinded, Placebo Controlled Clinical Trial. The hypothesis is that combination therapy with Andrographolid Sulfonatein injection and antibacterial is significantly better than antibacterial alone in achieving clinical stability among hospitalized CAP patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age of 18-75 years, no gender restrictions.\n* Voluntary participation, all participants provide written informed consent.\n* Volunteers are hospitalized patients\n* Patients are hospitalized for community acquired pneumonia with T≥38°C within 24 hours before being enrolled Diagnosis of CAP(Chinese Guideline for Diagnosis and Management of Community Acquired Pneumonia in Adults 2016)\n\n 1. Pneumonia that is acquired in community\n 2. Symptoms and signs of pneumonia:\n\n <!-- -->\n\n 1. Presence of cough, expectoration or exacerbation of chronic airways disease, with or without purulent sputum/chest pain/dyspnea/hemoptysis.\n 2. Presence offever.\n 3. Lung consolidation and/or moist rales.\n 4. Peripheral blood（WBC）\\>10×109/L or \\<4×109/L, with or without nuclear left shift; 3. Chest radiograph shows new ground-glass opacity, patchy infiltration, consolidation or interstitial changes, with or without pleural effusion.\n\nPatients who meet 1,3 and any one item in 2, exclude one of the following are clinically classified as CAP: pulmonary tuberculosis, cancer, non-infectious interstitial lung disease, pulmonary edema, atelectasis, pulmonary embolism, pulmonary eosinophilia and pulmonary vasculitis.\n\n* CURB 65≥1 point,Each risk factor scores one point, for a maximum score of 5:\n\n * Confusion of new onset\n * Blood Urea nitrogen greater than 7 mmol/l (19 mg/dL)\n * Respiratory rate of 30 breaths per minute or greater\n * Blood pressure less than 90 mmHg systolic or diastolic blood pressure 60 mmHg or less\n * Age 65 or older\n* Within 72 hours after symptom onset\n\nExclusion Criteria:\n\n* Known allergy to AS\n* Pregnant or breast-feeding\n* Heart dysfunction, NYHA III-IV class\n* Hematological system diseases, such as lymphoma, leukemia, agranulocytosis (neutrophil count\\< 0.5×109/L).\n* Autoimmune diseases and disease active\n* Terminal malignant tumor\n* Long-term treatment of high dose corticosteroids (prednisone 10mg/d ≥2 weeks) or immunosuppressive agents\n* Inflammatory bowel disease, such as Crohn's disease, ulcerative colitis\n* Chronic renal failure, eGFR\\<50 ml/min/1.73m2\n* Severe liver function damage, ALT or AST greater than or equal to 2 times the upper limit of normal\n* Hypernatremia, serum sodium≥145mmol/L\n* Diagnosis as severe pneumonia:\n\nDiagnostic criteria of severe pneumonia: patients who meet one major criteria or at least 3 of these minor criteria are classified as severe cases: Major criteria:①the need for invasive mechanical ventilation②sepsis shock after active fluid resuscitation still need vasoactive drugs; Minor criteria:①respiratory rate \\>30 breaths/min, ②PaO2/FiO2≤250mmHg（1mmHg=0.133kPa）, ③multilobar infiltrates, ④confusion or/andunorientation, ⑤bloodurea nitrogen level≥20mg/dl（7.14mmol/L）, ⑥systolic pressure \\<90mmHg need active fluid resuscitation\n\n* Defervescence by using corticosteroid after symptom onset.\n* Patients who participated another intervention study within a month\n* Other conditions not suitable for inclusion according to the investigator' judgment."}, 'identificationModule': {'nctId': 'NCT02913118', 'briefTitle': 'Adjunctive Therapy of Andrographolid Sulfonatein Community Acquired Pneumonia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Qingfeng Pharmaceutical Group'}, 'officialTitle': 'Adjunctive Therapy of Andrographolid Sulfonatein Community Acquired Pneumonia: A Multicenter Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'QF-CAP-20160402'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'standard antibiotic treatment +AS injection', 'description': 'Andrographolid Sulfonate Injection (AS Injection) plus one of 3 antibiotics in China CAP Guideline', 'interventionNames': ['Drug: Andrographolid Sulfonate Injection (AS Injection)', 'Drug: Cephalosporin', 'Drug: Azithromycin, Minocycline or Doxycycline', 'Drug: Amoxicillin-clavulantic acid', 'Drug: Fluoroquinolones']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'standard antibiotic treatment + AS placebo', 'description': 'AS placebo (NS injection) plus one of 3 antibiotics in China CAP Guideline', 'interventionNames': ['Drug: Cephalosporin', 'Drug: Azithromycin, Minocycline or Doxycycline', 'Drug: Amoxicillin-clavulantic acid', 'Drug: Fluoroquinolones', 'Drug: Placebo']}], 'interventions': [{'name': 'Andrographolid Sulfonate Injection (AS Injection)', 'type': 'DRUG', 'armGroupLabels': ['standard antibiotic treatment +AS injection']}, {'name': 'Cephalosporin', 'type': 'DRUG', 'armGroupLabels': ['standard antibiotic treatment + AS placebo', 'standard antibiotic treatment +AS injection']}, {'name': 'Azithromycin, Minocycline or Doxycycline', 'type': 'DRUG', 'armGroupLabels': ['standard antibiotic treatment + AS placebo', 'standard antibiotic treatment +AS injection']}, {'name': 'Amoxicillin-clavulantic acid', 'type': 'DRUG', 'armGroupLabels': ['standard antibiotic treatment + AS placebo', 'standard antibiotic treatment +AS injection']}, {'name': 'Fluoroquinolones', 'type': 'DRUG', 'armGroupLabels': ['standard antibiotic treatment + AS placebo', 'standard antibiotic treatment +AS injection']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['standard antibiotic treatment + AS placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100029', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaojing Cui, MD', 'role': 'CONTACT', 'email': 'cuixiaojing86@163.com', 'phone': '+86 10 84206269'}, {'name': 'Bin Cao, MD', 'role': 'CONTACT', 'email': 'caobin_ben@163.com', 'phone': '+86 13911318339'}], 'facility': 'China-Japan Friendship Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'China', 'facility': 'Beijing Chaoyang Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'China', 'facility': 'Beijing Hospital of TCM', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'China', 'facility': 'Beijing LuHe Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jin Chen, MD', 'role': 'CONTACT'}], 'facility': 'Fu Xing Hospital, Capital Medical Unviersity', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Wenzhou', 'state': 'Fujian', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'China', 'facility': 'The First Affiliated Hospital of Wenzhou University', 'geoPoint': {'lat': 24.14549, 'lon': 117.66081}}, {'city': 'Qinhuangdao', 'state': 'Hebei', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'China', 'facility': 'First Hospital of QinHuangDao', 'geoPoint': {'lat': 39.94104, 'lon': 119.58936}}, {'city': 'Shijiazhuang', 'state': 'Hebei', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'China', 'facility': 'The Second Hospital of Hebei Medical University', 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}, {'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'China', 'facility': 'Nanjing General Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'city': 'Nanchang', 'state': 'Jiangxi', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'China', 'facility': 'The First Affiliated Hospital of NanChang University', 'geoPoint': {'lat': 28.68396, 'lon': 115.85306}}, {'city': 'Shenyang', 'state': 'Liaoning', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'China', 'facility': 'The First Hospital of China Medical University', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'city': 'Qingdao', 'state': 'Shandong', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'China', 'facility': 'Qingdao Municipal Hospital', 'geoPoint': {'lat': 36.06488, 'lon': 120.38042}}, {'city': 'Zibo', 'state': 'Shandong', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'China', 'facility': 'The Central Hospital of ZiBo City', 'geoPoint': {'lat': 36.79056, 'lon': 118.06333}}, {'city': 'Taiyuan', 'state': 'Shanxi', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'China', 'facility': 'The First Hospital of Shanxi Medical University', 'geoPoint': {'lat': 37.86944, 'lon': 112.56028}}, {'city': 'Chengdu', 'state': 'Sichuan', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'China', 'facility': 'West China Hospital, Sichuan University', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'city': 'Tianjin', 'state': 'Tianjin Municipality', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'China', 'facility': 'The General Hospital of Tianjin Medical University', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'centralContacts': [{'name': 'Chen Wang, Professor', 'role': 'CONTACT', 'email': 'cyh-birm@263.net', 'phone': '+86 13901122992'}, {'name': 'Bin Cao, Professor', 'role': 'CONTACT', 'email': 'caobin_ben@163.com', 'phone': '+86 13911318339'}], 'overallOfficials': [{'name': 'Chen Wang, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'China-Japan Friendship Hospital'}, {'name': 'Bin Cao, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'China-Japan Friendship Hospital'}, {'name': 'Jin Chen, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fu Xing Hospital, Capital Medical University'}, {'name': 'Yuguang Wang, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing Hospital of TCM'}, {'name': 'Li Gu, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing Chao Yang Hospital'}, {'name': 'Zhenyang Xu, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Capital Medical University'}, {'name': 'Yan Yi, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'First Hospital of China Medical University'}, {'name': 'Wei Zhang, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital of Nanchang University'}, {'name': 'Shufeng Xu, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'First Hospital of Qinhuangdao'}, {'name': 'Bo Liu, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Central Hospital of ZiBo City'}, {'name': 'Jie Cao, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tianjin Medical University General Hospital'}, {'name': 'Yuping Li, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital of Wenzhou University'}, {'name': 'Xuedong Liu, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Qingdao Municipal Hospital'}, {'name': 'Hong Fan, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'West China Hospital'}, {'name': 'Zhigang Cai, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Second Hospital of Hebei Medical University'}, {'name': 'Xinri Zhang, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital of Shanxi Medical University'}, {'name': 'Xin Su, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nanjing General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qingfeng Pharmaceutical Group', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}