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| ID | Type | Description | Link |
|---|---|---|---|
| 2008_013 |
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The purpose of this study is to investigate the safety and efficacy of MK0991 in patients with deep-seated mycoses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Caspofungin | Experimental | caspofungin acetate (MK0991) |
|
| Micafungin | Active Comparator | Micafungin sodium |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| caspofungin acetate | Drug | Caspofungin acetate (50 mg/day for participants with esophageal candidiasis and 50 mg/day for participants with invasive candidiasis or aspergillosis after a 70 mg loading dose on Day 1), once daily intravenously (IV) for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Significant Drug-related Adverse Experience | A significant drug-related adverse experience was defined as a serious drug-related adverse experience or a drug-related adverse experience leading to study therapy discontinuation. | 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Specific Safety Finding | A specific safety finding was defined as a drug-related adverse experience, a serious drug-related adverse experience, or a drug-related adverse experience leading to study therapy discontinuation. | 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23052987 | Result | Kohno S, Izumikawa K, Yoshida M, Takesue Y, Oka S, Kamei K, Miyazaki Y, Yoshinari T, Kartsonis NA, Niki Y. A double-blind comparative study of the safety and efficacy of caspofungin versus micafungin in the treatment of candidiasis and aspergillosis. Eur J Clin Microbiol Infect Dis. 2013 Mar;32(3):387-97. doi: 10.1007/s10096-012-1754-z. Epub 2012 Oct 3. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Caspofungin | Caspofungin acetate (50 mg/day for participants with esophageal candidiasis and 50 mg/day for participants with invasive candidiasis or aspergillosis after a 70 mg loading dose on Day 1), once daily intravenously (IV) for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis. |
| FG001 | Micafungin | Micafungin sodium 150 mg/day, once daily IV for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Caspofungin | Caspofungin acetate (50 mg/day for participants with esophageal candidiasis and 50 mg/day for participants with invasive candidiasis or aspergillosis after a 70 mg loading dose on Day 1), once daily intravenously (IV) for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Participants With a Significant Drug-related Adverse Experience | A significant drug-related adverse experience was defined as a serious drug-related adverse experience or a drug-related adverse experience leading to study therapy discontinuation. | All Participants as Treated (APaT) population. | Posted | Number | Participants | 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Caspofungin | Caspofungin acetate (50 mg/day for participants with esophageal candidiasis and 50 mg/day for participants with invasive candidiasis or aspergillosis after a 70 mg loading dose on Day 1), once daily intravenously (IV) for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA (11.0) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA (11.0) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D009181 | Mycoses |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000077336 | Caspofungin |
| ID | Term |
|---|---|
| D055666 | Lipopeptides |
| D008055 | Lipids |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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|
| Comparator: Micafungin sodium | Drug | Micafungin sodium 150 mg/day, once daily IV, for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis. |
|
| Number of Participants With Favorable Overall Response at the End of Study Therapy | Favorable overall response for each infection category of deep-seated fungal infections was based on the determination of the Independent Efficacy Assessment Committee. | 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis |
| Lack of Efficacy |
|
| Discontinued for other reason |
|
| Withdrew consent |
|
| BG001 |
| Micafungin |
Micafungin sodium 150 mg/day, once daily IV for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 |
| Micafungin |
Micafungin sodium 150 mg/day, once daily IV for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis. |
|
|
| Secondary | Number of Participants With a Specific Safety Finding | A specific safety finding was defined as a drug-related adverse experience, a serious drug-related adverse experience, or a drug-related adverse experience leading to study therapy discontinuation. | APaT population. | Posted | Number | Participants | 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis |
|
|
|
| Secondary | Number of Participants With Favorable Overall Response at the End of Study Therapy | Favorable overall response for each infection category of deep-seated fungal infections was based on the determination of the Independent Efficacy Assessment Committee. | Per Protocol Set (PPS) population. | Posted | Number | Participants | 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis |
|
|
|
| 12 |
| 60 |
| 44 |
| 60 |
| EG001 | Micafungin | Micafungin sodium 150 mg/day, once daily IV for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis. | 14 | 60 | 40 | 60 |
| Inappropriate antidiuretic hormone secretion | Endocrine disorders | MedDRA (11.0) |
|
| Ileus paralytic | Gastrointestinal disorders | MedDRA (11.0) |
|
| Death | General disorders | MedDRA (11.0) |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA (11.0) |
|
| Bacteraemia | Infections and infestations | MedDRA (11.0) |
|
| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA (11.0) |
|
| Infection | Infections and infestations | MedDRA (11.0) |
|
| Pneumonia | Infections and infestations | MedDRA (11.0) |
|
| Sepsis | Infections and infestations | MedDRA (11.0) |
|
| Septic shock | Infections and infestations | MedDRA (11.0) |
|
| Alanine aminotransferase increased | Investigations | MedDRA (11.0) |
|
| Aspartate aminotransferase increased | Investigations | MedDRA (11.0) |
|
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) |
|
| Mesothelioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) |
|
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) |
|
| Peritoneal mesothelioma malignant advanced | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) |
|
| Cerebral infarction | Nervous system disorders | MedDRA (11.0) |
|
| Cerebrovascular disorder | Nervous system disorders | MedDRA (11.0) |
|
| Renal failure acute | Renal and urinary disorders | MedDRA (11.0) |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) |
|
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (11.0) |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (11.0) |
|
| Nausea | Gastrointestinal disorders | MedDRA (11.0) |
|
| Vomiting | Gastrointestinal disorders | MedDRA (11.0) |
|
| Injection site pain | General disorders | MedDRA (11.0) |
|
| Malaise | General disorders | MedDRA (11.0) |
|
| Oedema | General disorders | MedDRA (11.0) |
|
| Pyrexia | General disorders | MedDRA (11.0) |
|
| Nasopharyngitis | Infections and infestations | MedDRA (11.0) |
|
| Pneumonia | Infections and infestations | MedDRA (11.0) |
|
| Alanine aminotransferase increased | Investigations | MedDRA (11.0) |
|
| Aspartate aminotransferase increased | Investigations | MedDRA (11.0) |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA (11.0) |
|
| Blood glucose increased | Investigations | MedDRA (11.0) |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA (11.0) |
|
| Blood potassium decreased | Investigations | MedDRA (11.0) |
|
| Blood potassium increased | Investigations | MedDRA (11.0) |
|
| Blood pressure increased | Investigations | MedDRA (11.0) |
|
| C-reactive protein increased | Investigations | MedDRA (11.0) |
|
| Eosinophil count increased | Investigations | MedDRA (11.0) |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA (11.0) |
|
| Whtie blood cell count increased | Investigations | MedDRA (11.0) |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA (11.0) |
|
| Headache | Nervous system disorders | MedDRA (11.0) |
|
| Insomnia | Psychiatric disorders | MedDRA (11.0) |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (11.0) |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (11.0) |
|
The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission. SPONSOR review can be expedited to meet publication guidelines.
| D054714 |
| Echinocandins |
| D010456 | Peptides, Cyclic |
| Discontinued by drug-related adverse experience |
|
| Aspergillosis (n=30, n=33) |
|