Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-29 @ 3:49 PM
Study NCT ID:
NCT00520234
Status:
COMPLETED
Last Update Posted:
2011-05-09
First Post:
2007-08-21
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Randomized Study of Caspofungin Prophylaxis Followed by Pre-emptive Therapy for Invasive Candidiasis in the Intensive Care Unit (ICU)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058365', 'term': 'Candidiasis, Invasive'}, {'id': 'C536972', 'term': 'Torulopsis'}], 'ancestors': [{'id': 'D002177', 'term': 'Candidiasis'}, {'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000072742', 'term': 'Invasive Fungal Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077336', 'term': 'Caspofungin'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D055666', 'term': 'Lipopeptides'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D054714', 'term': 'Echinocandins'}, {'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Luis.Ostrosky-Zeichner@uth.tmc.edu', 'phone': '(713) 500-6733', 'title': 'Luis Ostrosky-Zeichner, MD', 'organization': 'Mycoses Study Group'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Within 14 days of completion of study therapy.', 'eventGroups': [{'id': 'EG000', 'title': 'Prophylaxis', 'description': 'Caspofungin 50 mg IV daily up to 28 days of therapy', 'otherNumAtRisk': 117, 'otherNumAffected': 106, 'seriousNumAtRisk': 117, 'seriousNumAffected': 33}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Normal Saline 100 cc IV daily', 'otherNumAtRisk': 102, 'otherNumAffected': 87, 'seriousNumAtRisk': 102, 'seriousNumAffected': 28}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 13}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Blood urea increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Hypophosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Decubitus ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}], 'seriousEvents': [{'term': 'Atrioventricular extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Bradyarrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Cardiomyopathy acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Electromechanical dissociation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Chronic gastrointestinal bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Intestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Pneumoperitoneum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Multi-organ failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Sudden death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Abdominal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Transaminases increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Brain stem infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Grand mal convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Haemorrhage intracranial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Haemorrhagic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Metabolic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Spinal cord infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Acute respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Pulmonary fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Pulmonary hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Peripheral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proven and Probable Invasive Candidiasis Based on Modified Mycoses Study Group/European Organization for Research and Treatment of Cancer (MSG/EORTC) Criteria.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prophylaxis', 'description': 'Caspofungin 50mg IV daily'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Normal Saline 100 cc IV daily'}], 'classes': [{'categories': [{'measurements': [{'value': '9.8', 'groupId': 'OG000'}, {'value': '16.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.14', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'APACHE II Stratified', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Within 7 days after end of therapy', 'description': 'Modified MSG/EORTC criteria for the diagnosis of fungal infections: Proven invasive candidiasis is defined as candidemia, Candida cultured from a sterile site, or histopathological evidence of candida infection. Probable invasive candidiasis is defined as 2 consecutive positive beta glucan levels in the presence of signs and symptoms of infection.', 'unitOfMeasure': 'percent of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat population, defined as subjects who received at least one dose of study drug and did not have baseline invasive candidiasis.'}, {'type': 'SECONDARY', 'title': 'Incidence of Proven Invasive Candidiasis by MSG/ EORTC Criteria.', 'timeFrame': 'Within 7 days of end of therapy', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'All Cause Mortality', 'timeFrame': 'Within 7 days of end of therapy', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Initiation of Other Antifungals', 'timeFrame': 'Within 7 days after end of therapy', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Development of Proven or Probable Invasive Candidiasis', 'timeFrame': 'Within 7 days after end of therapy', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Incidence of Proven and Probable Invasive Fungal Infections Other Than Invasive Candidiasis.', 'timeFrame': 'Within 7 days after end of therapy', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Beta Glucan Negativity in Pre-emptive Phase.', 'timeFrame': 'Within 14 days after end of therapy', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Incidence of Complete and Partial Response by Clinical and Microbiological or Serological Evidence for Subjects on the Pre-emptive Therapy Phase.', 'timeFrame': 'Within 14 days after end of therapy', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Hospital Metrics (to be Evaluated Separately for Prophylaxis and Pre-emptive Therapy Phases); Length of Stay in the Hospital, Length of Stay in the ICU, and the Costs Data for the ICU Stay and the Hospitalization, if Available.', 'timeFrame': 'Hospital discharge', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Subjects Who Discontinue Study Therapy Due to a Drug-related Adverse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prophylaxis', 'description': 'Caspofungin 50 mg IV daily up to 28 days of therapy'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Normal Saline 100 cc IV daily'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 14 days after end of therapy', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population, defined as all subjects who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Subjects With 1 or More Serious Drug-related Adverse Event(s)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prophylaxis', 'description': 'Caspofungin 50 mg IV daily up to 28 days of therapy'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Normal Saline 100 cc IV daily'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 14 days after end of therapy', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population, defined as all subjects who received at least one dose of study drug.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Prophylaxis', 'description': 'Caspofungin 50 mg IV daily up to 28 days of therapy'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Normal Saline 100 cc IV daily'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '118'}, {'groupId': 'FG001', 'numSubjects': '104'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '117'}, {'groupId': 'FG001', 'numSubjects': '102'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '219', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Prophylaxis', 'description': 'Caspofungin 50 mg IV daily up to 28 days of therapy'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Normal Saline 100 cc IV daily'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.2', 'spread': '17.5', 'groupId': 'BG000'}, {'value': '56.7', 'spread': '16.6', 'groupId': 'BG001'}, {'value': '57.5', 'spread': '17.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '132', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '109', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '203', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '78', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '138', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Acute Physiology And Chronic Health Evaluation (APACHE) II score (minimum 0, maximum 71)', 'classes': [{'categories': [{'measurements': [{'value': '25.3', 'spread': '8.0', 'groupId': 'BG000'}, {'value': '25.1', 'spread': '8.7', 'groupId': 'BG001'}, {'value': '25.2', 'spread': '8.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 222}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-04', 'completionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-04-08', 'studyFirstSubmitDate': '2007-08-21', 'resultsFirstSubmitDate': '2011-03-15', 'studyFirstSubmitQcDate': '2007-08-22', 'lastUpdatePostDateStruct': {'date': '2011-05-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-04-08', 'studyFirstPostDateStruct': {'date': '2007-08-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-05-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proven and Probable Invasive Candidiasis Based on Modified Mycoses Study Group/European Organization for Research and Treatment of Cancer (MSG/EORTC) Criteria.', 'timeFrame': 'Within 7 days after end of therapy', 'description': 'Modified MSG/EORTC criteria for the diagnosis of fungal infections: Proven invasive candidiasis is defined as candidemia, Candida cultured from a sterile site, or histopathological evidence of candida infection. Probable invasive candidiasis is defined as 2 consecutive positive beta glucan levels in the presence of signs and symptoms of infection.'}], 'secondaryOutcomes': [{'measure': 'Incidence of Proven Invasive Candidiasis by MSG/ EORTC Criteria.', 'timeFrame': 'Within 7 days of end of therapy'}, {'measure': 'All Cause Mortality', 'timeFrame': 'Within 7 days of end of therapy'}, {'measure': 'Initiation of Other Antifungals', 'timeFrame': 'Within 7 days after end of therapy'}, {'measure': 'Time to Development of Proven or Probable Invasive Candidiasis', 'timeFrame': 'Within 7 days after end of therapy'}, {'measure': 'Incidence of Proven and Probable Invasive Fungal Infections Other Than Invasive Candidiasis.', 'timeFrame': 'Within 7 days after end of therapy'}, {'measure': 'Time to Beta Glucan Negativity in Pre-emptive Phase.', 'timeFrame': 'Within 14 days after end of therapy'}, {'measure': 'Incidence of Complete and Partial Response by Clinical and Microbiological or Serological Evidence for Subjects on the Pre-emptive Therapy Phase.', 'timeFrame': 'Within 14 days after end of therapy'}, {'measure': 'Hospital Metrics (to be Evaluated Separately for Prophylaxis and Pre-emptive Therapy Phases); Length of Stay in the Hospital, Length of Stay in the ICU, and the Costs Data for the ICU Stay and the Hospitalization, if Available.', 'timeFrame': 'Hospital discharge'}, {'measure': 'Subjects Who Discontinue Study Therapy Due to a Drug-related Adverse Event', 'timeFrame': 'Up to 14 days after end of therapy'}, {'measure': 'Subjects With 1 or More Serious Drug-related Adverse Event(s)', 'timeFrame': 'Up to 14 days after end of therapy'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Candida', 'Prophylaxis', 'High risk adults', 'Intensive care unit (ICU)'], 'conditions': ['Invasive Candidiasis']}, 'referencesModule': {'references': [{'pmid': '11923348', 'type': 'BACKGROUND', 'citation': 'Diekema DJ, Messer SA, Brueggemann AB, Coffman SL, Doern GV, Herwaldt LA, Pfaller MA. Epidemiology of candidemia: 3-year results from the emerging infections and the epidemiology of Iowa organisms study. J Clin Microbiol. 2002 Apr;40(4):1298-302. doi: 10.1128/JCM.40.4.1298-1302.2002.'}, {'pmid': '7548503', 'type': 'BACKGROUND', 'citation': 'Jarvis WR. Epidemiology of nosocomial fungal infections, with emphasis on Candida species. Clin Infect Dis. 1995 Jun;20(6):1526-30. doi: 10.1093/clinids/20.6.1526.'}, {'pmid': '1542320', 'type': 'BACKGROUND', 'citation': 'Goodman JL, Winston DJ, Greenfield RA, Chandrasekar PH, Fox B, Kaizer H, Shadduck RK, Shea TC, Stiff P, Friedman DJ, et al. A controlled trial of fluconazole to prevent fungal infections in patients undergoing bone marrow transplantation. N Engl J Med. 1992 Mar 26;326(13):845-51. doi: 10.1056/NEJM199203263261301.'}, {'pmid': '12039879', 'type': 'BACKGROUND', 'citation': 'Denning DW. Echinocandins: a new class of antifungal. J Antimicrob Chemother. 2002 Jun;49(6):889-91. doi: 10.1093/jac/dkf045. No abstract available.'}, {'pmid': '24550378', 'type': 'DERIVED', 'citation': 'Ostrosky-Zeichner L, Shoham S, Vazquez J, Reboli A, Betts R, Barron MA, Schuster M, Judson MA, Revankar SG, Caeiro JP, Mangino JE, Mushatt D, Bedimo R, Freifeld A, Nguyen MH, Kauffman CA, Dismukes WE, Westfall AO, Deerman JB, Wood C, Sobel JD, Pappas PG. MSG-01: A randomized, double-blind, placebo-controlled trial of caspofungin prophylaxis followed by preemptive therapy for invasive candidiasis in high-risk adults in the critical care setting. Clin Infect Dis. 2014 May;58(9):1219-26. doi: 10.1093/cid/ciu074. Epub 2014 Feb 18.'}]}, 'descriptionModule': {'briefSummary': 'Adults admitted to intensive care units are at risk for a variety of complications. Infections due to the fungus called candida are of particular concern. The study will test the possibility that caspofungin, a new therapy for fungal infections, can successfully reduce the rate of candida infections in subjects at risk. It will also test if caspofungin is useful in treating subjects for this disease when diagnosed using a new blood test that is performed twice weekly, permitting earlier diagnosis than current practice standards.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Non-pregnant \\>18 yrs of age\n* Subjects admitted to ICU during the preceding 3 days and expected to stay in the ICU for at least another 48 hours.Subjects can be enrolled on days 3-5 of ICU admission.\n* Subjects meeting the clinical prediction rule\n\nExclusion Criteria:\n\n* Subjects with an allergy/intolerance to caspofungin or echinocandin analog\n* absolute neutrophil count \\<500/mm3 at study entry or likely to develop such a count during therapy\n* acquired immunodeficiency syndrome, aplastic anemia or chronic granulomatous disease\n* moderate or severe hepatic insufficiency\n* subjects who are pregnant or lactating\n* unlikely to survive \\< 24 hours\n* subjects who have received systemic antifungal therapy within 10 days prior to study entry\n* Documented active proven or probable invasive fungal infection upon enrollment\n* previously enrolled in this study\n* Currently on another investigational agent or have received an investigational agent within 10 days prior to study entry.'}, 'identificationModule': {'nctId': 'NCT00520234', 'acronym': 'MSG-01', 'briefTitle': 'Randomized Study of Caspofungin Prophylaxis Followed by Pre-emptive Therapy for Invasive Candidiasis in the Intensive Care Unit (ICU)', 'organization': {'class': 'NETWORK', 'fullName': 'Mycoses Study Group'}, 'officialTitle': 'A Randomized, Double-blind, Placebo Controlled Trial of Caspofungin Prophylaxis Followed by Pre-emptive Therapy for Invasive Candidiasis in High-risk Adults in the Critical Care Setting', 'orgStudyIdInfo': {'id': 'MSG-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1 prophylaxis', 'description': 'Caspofungin 50 mg Intravenous (IV) daily up to 28 days of therapy', 'interventionNames': ['Drug: Caspofungin']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2 placebo', 'description': 'Normal Saline 100 cc IV daily', 'interventionNames': ['Drug: Normal Saline']}], 'interventions': [{'name': 'Caspofungin', 'type': 'DRUG', 'description': '50 mg IV daily', 'armGroupLabels': ['1 prophylaxis']}, {'name': 'Normal Saline', 'type': 'DRUG', 'otherNames': ['placebo'], 'description': '100 cc IV daily', 'armGroupLabels': ['2 placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35124', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '29425', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of Southern California', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '80262', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Washington Hospital Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Tulane University', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Harper University Hospital/ Wayne State', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Hospital', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '59802', 'city': 'Missoula', 'state': 'Montana', 'country': 'United States', 'facility': "St. Patrick's Hospital", 'geoPoint': {'lat': 46.87215, 'lon': -113.994}}, {'zip': '08103', 'city': 'Camden', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Cooper University Hospital', 'geoPoint': {'lat': 39.92595, 'lon': -75.11962}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical Center of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}], 'overallOfficials': [{'name': 'Luis Ostrosky-Zeichner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center, Houston'}, {'name': 'Peter G Pappas, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mycoses Study Group'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mycoses Study Group', 'class': 'NETWORK'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Merck', 'oldOrganization': 'Merck'}}}}