Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011014', 'term': 'Pneumonia'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C547755', 'term': 'solithromycin'}, {'id': 'D000077266', 'term': 'Moxifloxacin'}], 'ancestors': [{'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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 863}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'dispFirstSubmitDate': '2015-11-03', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-01', 'studyFirstSubmitDate': '2013-10-21', 'dispFirstSubmitQcDate': '2015-11-03', 'studyFirstSubmitQcDate': '2013-10-23', 'dispFirstPostDateStruct': {'date': '2015-12-01', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2017-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-10-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Early clinical response rate in the Intent to Treat (ITT) population.', 'timeFrame': '72 [±12] hours after the first dose of study drug', 'description': 'To determine noninferiority (NI) in early clinical response rate, in at least 2 of the following 4 cardinal symptoms: cough, shortness of breath, chest pain, and sputum production'}], 'secondaryOutcomes': [{'measure': 'Early clinical response rate in the microITT population', 'timeFrame': '72 [±12] hours after the first dose of study drug', 'description': 'To determine NI in early clinical response rate of intravenous to oral solithromycin compared to intravenous to oral moxifloxacin in the mITT population'}, {'measure': 'Clinical success rates in the ITT and Clinically Evaluable (CE) populations', 'timeFrame': '5 to 10 days after the last dose of study drug', 'description': 'To determine the overall clinical success rates of intravenous to oral solithromycin compared to moxifloxacin'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pneumonia', 'CABP', 'CAP', 'Macrolide'], 'conditions': ['Community-acquired Bacterial Pneumonia']}, 'referencesModule': {'references': [{'pmid': '27448679', 'type': 'DERIVED', 'citation': 'File TM Jr, Rewerska B, Vucinic-Mihailovic V, Gonong JRV, Das AF, Keedy K, Taylor D, Sheets A, Fernandes P, Oldach D, Jamieson BD. SOLITAIRE-IV: A Randomized, Double-Blind, Multicenter Study Comparing the Efficacy and Safety of Intravenous-to-Oral Solithromycin to Intravenous-to-Oral Moxifloxacin for Treatment of Community-Acquired Bacterial Pneumonia. Clin Infect Dis. 2016 Oct 15;63(8):1007-1016. doi: 10.1093/cid/ciw490. Epub 2016 Jul 22.'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the safety and efficacy of an experimental antibiotic, solithromycin, in the treatment of adult patients with community-acquired pneumonia.', 'detailedDescription': 'Community-acquired bacterial pneumonia (CABP) is an acute infection of the pulmonary parenchyma with symptoms such as fever or hypothermia, chills, rigors, chest pain, and/or dyspnea. The widespread emergence of antibiotic resistant pathogens, including the macrolide-resistant Streptococcus pneumoniae, has resulted in a need for new and effective antibiotics that have activity against CABP pathogens. Solithromycin is a fourth generation macrolide antibiotic with excellent activity against resistant S. pneumoniae and other key typical and atypical bacterial respiratory pathogens. A completed Phase 2 study showed comparable efficacy to levofloxacin in adults with CABP.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female patients ≥ 18 years of age\n* An acute onset of at least 3 of the following signs and symptoms (new or worsening):\n\n 1. Cough\n 2. Production of purulent sputum\n 3. Shortness of breath (dyspnea)\n 4. Chest pain due to pneumonia\n* At least 1 of the following:\n\n 1. Fever\n 2. Hypothermia\n 3. Presence of pulmonary rales and/or evidence of pulmonary consolidation\n* PORT Risk Class II, III, or IV\n* Presence of lobar, multilobar, or patchy parenchymal infiltrate(s) consistent with acute bacterial pneumonia on a pulmonary imaging study\n* Not received any systemic antibiotics during the prior 7 days\n\nExclusion Criteria:\n\n* Ventilator-associated pneumonia\n* Known anatomical or pathological bronchial obstruction or a history of bronchiectasis or documented severe chronic obstructive pulmonary disease\n* Hospitalization within 90 days or residence in a long-term care facility within 30 days prior to the onset of symptoms\n* Fungal pneumonia\n* Pneumocystis jiroveci pneumonia\n* Aspiration pneumonia\n* Other non-infectious causes of pulmonary infiltrates\n* Primary or metastatic lung cancer\n* Cystic fibrosis\n* Active or suspected tuberculosis\n* HIV or myasthenia gravis'}, 'identificationModule': {'nctId': 'NCT01968733', 'acronym': 'SOLITAIRE-IV', 'briefTitle': 'Efficacy and Safety Study of Intravenous to Oral Solithromycin (CEM-101) Compared to Intravenous to Oral Moxifloxacin in Treatment of Patients With Community-Acquired Bacterial Pneumonia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Melinta Therapeutics, Inc.'}, 'officialTitle': 'A Randomized, Double-Blind, Multi-Center Study to Evaluate the Efficacy and Safety of Intravenous to Oral Solithromycin (CEM-101) Compared to Intravenous to Oral Moxifloxacin in the Treatment of Adult Patients With Community-Acquired Bacterial Pneumonia', 'orgStudyIdInfo': {'id': 'CE01-301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Moxifloxacin', 'description': 'Intravenous with the potential step-down to oral moxifloxacin', 'interventionNames': ['Drug: Moxifloxacin']}, {'type': 'EXPERIMENTAL', 'label': 'Solithromycin', 'description': 'Intravenous with potential step-down to oral solithromycin', 'interventionNames': ['Drug: Solithromycin']}], 'interventions': [{'name': 'Solithromycin', 'type': 'DRUG', 'otherNames': ['CEM-101'], 'armGroupLabels': ['Solithromycin']}, {'name': 'Moxifloxacin', 'type': 'DRUG', 'otherNames': ['Avelox'], 'armGroupLabels': ['Moxifloxacin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36607', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '36609', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '91710', 'city': 'Chino', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.01223, 'lon': -117.68894}}, {'zip': '91206', 'city': 'Glendale', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.14251, 'lon': -118.25508}}, {'zip': '92653', 'city': 'Laguna Hills', 'state': 'California', 'country': 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