Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 prophylaxis | Active Comparator | Caspofungin 50 mg Intravenous (IV) daily up to 28 days of therapy |
|
| 2 placebo | Placebo Comparator | Normal Saline 100 cc IV daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Caspofungin | Drug | 50 mg IV daily |
| |
| Normal Saline |
| Measure | Description | Time Frame |
|---|---|---|
| Proven and Probable Invasive Candidiasis Based on Modified Mycoses Study Group/European Organization for Research and Treatment of Cancer (MSG/EORTC) Criteria. | 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. | Within 7 days after end of therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Proven Invasive Candidiasis by MSG/ EORTC Criteria. | Within 7 days of end of therapy | |
| All Cause Mortality | Within 7 days of end of therapy | |
| Initiation of Other Antifungals |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Luis Ostrosky-Zeichner, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Peter G Pappas, MD | Mycoses Study Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35124 | United States | ||
| University of Southern California |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11923348 | Background | 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. | |
| 7548503 | Background | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Prophylaxis | Caspofungin 50 mg IV daily up to 28 days of therapy |
| FG001 | Placebo | Normal Saline 100 cc IV daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
100 cc IV daily |
|
|
| Within 7 days after end of therapy |
| Time to Development of Proven or Probable Invasive Candidiasis | Within 7 days after end of therapy |
| Incidence of Proven and Probable Invasive Fungal Infections Other Than Invasive Candidiasis. | Within 7 days after end of therapy |
| Time to Beta Glucan Negativity in Pre-emptive Phase. | Within 14 days after end of therapy |
| Incidence of Complete and Partial Response by Clinical and Microbiological or Serological Evidence for Subjects on the Pre-emptive Therapy Phase. | Within 14 days after end of therapy |
| 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. | Hospital discharge |
| Subjects Who Discontinue Study Therapy Due to a Drug-related Adverse Event | Up to 14 days after end of therapy |
| Subjects With 1 or More Serious Drug-related Adverse Event(s) | Up to 14 days after end of therapy |
| Los Angeles |
| California |
| 29425 |
| United States |
| University of Colorado | Denver | Colorado | 80262 | United States |
| Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States |
| Tulane University | New Orleans | Louisiana | 70112 | United States |
| Harper University Hospital/ Wayne State | Detroit | Michigan | 48201 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| St. Patrick's Hospital | Missoula | Montana | 59802 | United States |
| Cooper University Hospital | Camden | New Jersey | 08103 | United States |
| The Ohio State University | Columbus | Ohio | 43210 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Medical Center of South Carolina | Charleston | South Carolina | 29425 | United States |
| 1542320 | Background | 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. |
| 12039879 | Background | 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. |
| 24550378 | Derived | 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Prophylaxis | Caspofungin 50 mg IV daily up to 28 days of therapy |
| BG001 | Placebo | Normal Saline 100 cc IV daily |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Acute Physiology And Chronic Health Evaluation (APACHE) II score (minimum 0, maximum 71) | Mean | Standard Deviation | Score on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proven and Probable Invasive Candidiasis Based on Modified Mycoses Study Group/European Organization for Research and Treatment of Cancer (MSG/EORTC) Criteria. | 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. | Modified intent-to-treat population, defined as subjects who received at least one dose of study drug and did not have baseline invasive candidiasis. | Posted | Number | percent of participants | Within 7 days after end of therapy |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Incidence of Proven Invasive Candidiasis by MSG/ EORTC Criteria. | Not Posted | Within 7 days of end of therapy | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | All Cause Mortality | Not Posted | Within 7 days of end of therapy | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Initiation of Other Antifungals | Not Posted | Within 7 days after end of therapy | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Development of Proven or Probable Invasive Candidiasis | Not Posted | Within 7 days after end of therapy | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Incidence of Proven and Probable Invasive Fungal Infections Other Than Invasive Candidiasis. | Not Posted | Within 7 days after end of therapy | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Beta Glucan Negativity in Pre-emptive Phase. | Not Posted | Within 14 days after end of therapy | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Incidence of Complete and Partial Response by Clinical and Microbiological or Serological Evidence for Subjects on the Pre-emptive Therapy Phase. | Not Posted | Within 14 days after end of therapy | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Not Posted | Hospital discharge | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Subjects Who Discontinue Study Therapy Due to a Drug-related Adverse Event | Safety population, defined as all subjects who received at least one dose of study drug. | Posted | Number | participants | Up to 14 days after end of therapy |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Subjects With 1 or More Serious Drug-related Adverse Event(s) | Safety population, defined as all subjects who received at least one dose of study drug. | Posted | Number | participants | Up to 14 days after end of therapy |
|
|
Within 14 days of completion of study therapy.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Prophylaxis | Caspofungin 50 mg IV daily up to 28 days of therapy | 33 | 117 | 106 | 117 | ||
| EG001 | Placebo | Normal Saline 100 cc IV daily | 28 | 102 | 87 | 102 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrioventricular extrasystoles | Cardiac disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Bradyarrhythmia | Congenital, familial and genetic disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Cardiomyopathy acute | Cardiac disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Electromechanical dissociation | Cardiac disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Chronic gastrointestinal bleeding | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Intestinal haemorrhage | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Pneumoperitoneum | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Sudden death | General disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Abdominal sepsis | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) | Non-systematic Assessment |
| |
| Brain stem infarction | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Grand mal convulsion | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Haemorrhagic stroke | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Metabolic encephalopathy | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Spinal cord infarction | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Shock | Vascular disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Blood urea increased | Investigations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Hyperglycaemia | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (10.1) | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Luis Ostrosky-Zeichner, MD | Mycoses Study Group | (713) 500-6733 | Luis.Ostrosky-Zeichner@uth.tmc.edu |
| ID | Term |
|---|---|
| D058365 | Candidiasis, Invasive |
| C536972 | Torulopsis |
| ID | Term |
|---|---|
| D002177 | Candidiasis |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D000072742 | Invasive Fungal Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077336 | Caspofungin |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D055666 | Lipopeptides |
| D008055 | Lipids |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D054714 | Echinocandins |
| D010456 | Peptides, Cyclic |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|