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| ID | Type | Description | Link |
|---|---|---|---|
| 2008_001 |
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To evaluate the safety, tolerability, and efficacy of caspofungin for the treatment of esophageal candidiasis and invasive candidiasis to support the registration of caspofungin for these indications in China.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Caspofungin 50 mg Intravenous (IV) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| caspofungin acetate | Drug | Intravenous (IV) caspofungin acetate 50 mg/day. Participants with esophageal candidiasis will be treated for at least 7 days and for at least 72 hours after symptoms resolve for a maximum of 28 days; participants with invasive candidiasis will have a 70 mg loading dose on study day 1 and will be treated for at least 14 days after the last positive culture of Candida from the blood or other normally sterile body site for a maximum of 60 days; these participants should also have improvement in clinical and radiographic signs of disease for at least 48 hours before completion of the study therapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With One or More Drug-related Serious Adverse Events | A serious adverse event is one that results in death, disability/incapacity, or hospitalization or is life threatening, a congenital anomaly or birth defect, cancer, an overdose, or otherwise jeopardizes the patient and may require medical intervention. A drug-related adverse event is a determination by the investigator physician that the study drug caused the event based on exposure, time course, likely cause, dechallenge (event resolved/improved when drug was discontinued), rechallenge (event resolved/improved when drug was re-introduced), and consistency with the drug profile. | First dose of study drug through 14 days post therapy (maximum 28 days of study drug for esophageal candidiasis, 60 days for invasive candidiasis; mean treatment duration of 14 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With One or More Drug-related Adverse Events | A drug-related adverse event is a determination by the investigator physician that the study drug caused the event based on exposure, time course, likely cause, dechallenge (event resolved/improved when drug was discontinued), rechallenge (event resolved/improved when drug was re-introduced), and consistency with the drug profile. |
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Inclusion Criteria:
Exclusion Criteria:
aspartate aminotransferase (AST, or serum glutamic oxaloacetic transaminase [SGOT]) or alanine aminotransferase (ALT, or serum glutamic pyruvic transaminase [SGPT]) >5 times the upper limit of normal range
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Lin DF, Wang JM, Yu YS; Han MZ, Shen ZX, Song SD, Zhang YY. A non-controlled, multicenter, open-label study to evaluate the safety, tolerability, and efficacy of caspofungin acetate for the treatment of invasive candidiasis in Chinese adults . Chin J Infect Chemother. 2014;14(5):379-385. [in Chinese] |
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| ID | Title | Description |
|---|---|---|
| FG000 | Caspofungin 50 mg q.d. Intravenous (IV) | Three participants with esophageal candidiasis were treated with IV caspofungin 50 mg daily (q.d.) for at least 7 days and for at least 72 hours past the resolution of symptoms for a maximum treatment duration of 28 days. After a 70 mg loading dose on Study Day 1, 60 participants with invasive candidiasis were treated with IV caspofungin 50 mg q.d. for at least 14 days after the last positive culture of Candida from the blood or other normally sterile body site for a maximum treatment duration of 60 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Caspofungin 50 mg q.d. Intravenous (IV) | Three participants with esophageal candidiasis were treated with IV caspofungin 50 mg daily (q.d.) for at least 7 days and for at least 72 hours past the resolution of symptoms for a maximum treatment duration of 28 days. After a 70 mg loading dose on Study Day 1, 60 participants with invasive candidiasis were treated with IV caspofungin 50 mg q.d. for at least 14 days after the last positive culture of Candida from the blood or other normally sterile body site for a maximum treatment duration of 60 days. |
| 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 One or More Drug-related Serious Adverse Events | A serious adverse event is one that results in death, disability/incapacity, or hospitalization or is life threatening, a congenital anomaly or birth defect, cancer, an overdose, or otherwise jeopardizes the patient and may require medical intervention. A drug-related adverse event is a determination by the investigator physician that the study drug caused the event based on exposure, time course, likely cause, dechallenge (event resolved/improved when drug was discontinued), rechallenge (event resolved/improved when drug was re-introduced), and consistency with the drug profile. | Posted | Number | Participants | First dose of study drug through 14 days post therapy (maximum 28 days of study drug for esophageal candidiasis, 60 days for invasive candidiasis; mean treatment duration of 14 days) |
|
First dose of study drug through 14 days post therapy (maximum 28 days of study drug for esophageal candidiasis, 60 days for invasive candidiasis; mean treatment duration of 14 days)
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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 50 mg q.d. IV | Three participants with esophageal candidiasis were treated with IV caspofungin 50 mg daily (q.d.) for at least 7 days and for at least 72 hours past the resolution of symptoms for a maximum treatment duration of 28 days. After a 70 mg loading dose on Study Day 1, 60 participants with invasive candidiasis were treated with IV caspofungin 50 mg q.d. for at least 14 days after the last positive culture of Candida from the blood or other normally sterile body site for a maximum treatment duration of 60 days. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Failure | Cardiac disorders | MedDRA 14.0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Failure | Cardiac disorders | MedDRA 14.0 |
This was an open-label non-comparative study with a relatively small sample size.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | 1-800-672-6372 | 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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|
|
| First dose of study drug through 14 days post therapy (maximum 28 days of study drug for esophageal candidiasis, 60 days for invasive candidiasis; mean treatment duration of 14 days) |
| Number of Participants Who Discontinued Due to a Drug-related Adverse Event | A drug-related adverse event is a determination by the investigator physician that the study drug caused the event based on exposure, time course, likely cause, dechallenge (event resolved/improved when drug was discontinued), rechallenge (event resolved/improved when drug was re-introduced), and consistency with the drug profile. | First dose of study drug through 14 days post therapy (maximum 28 days of study drug for esophageal candidiasis, 60 days for invasive candidiasis; mean treatment duration of 14 days) |
| Number of Participants With Favorable Overall Response for Esophageal Candidiasis or Invasive Candidiasis | Efficacy response for esophageal candidiasis was based on clinical and endoscopic criteria; favorable responses included complete and partial improvement in symptoms and endoscopic lesions. Efficacy response for invasive candidiasis was based on microbiological and clinical assessments; favorable responses required both favorable microbiological response (i.e., eradication or presumptive eradication based on symptoms, physical exam, and non-invasive tests) and complete or partial clinical response. | First dose of study drug through up to 60 days of therapy (maximum 28 days of study drug for esophageal candidiasis, 60 days for invasive candidiasis; mean treatment duration of 14 days) |
| Rapid progression of baseline disease |
|
| Use of other antifungal agent needed |
|
| No improvement after 7-10 days treatment |
|
| Noncompliance with protocol |
|
| Other reason |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Number of Participants With One or More Drug-related Adverse Events | A drug-related adverse event is a determination by the investigator physician that the study drug caused the event based on exposure, time course, likely cause, dechallenge (event resolved/improved when drug was discontinued), rechallenge (event resolved/improved when drug was re-introduced), and consistency with the drug profile. | Posted | Number | Participants | First dose of study drug through 14 days post therapy (maximum 28 days of study drug for esophageal candidiasis, 60 days for invasive candidiasis; mean treatment duration of 14 days) |
|
|
|
| Secondary | Number of Participants Who Discontinued Due to a Drug-related Adverse Event | A drug-related adverse event is a determination by the investigator physician that the study drug caused the event based on exposure, time course, likely cause, dechallenge (event resolved/improved when drug was discontinued), rechallenge (event resolved/improved when drug was re-introduced), and consistency with the drug profile. | Posted | Number | Participants | First dose of study drug through 14 days post therapy (maximum 28 days of study drug for esophageal candidiasis, 60 days for invasive candidiasis; mean treatment duration of 14 days) |
|
|
|
| Secondary | Number of Participants With Favorable Overall Response for Esophageal Candidiasis or Invasive Candidiasis | Efficacy response for esophageal candidiasis was based on clinical and endoscopic criteria; favorable responses included complete and partial improvement in symptoms and endoscopic lesions. Efficacy response for invasive candidiasis was based on microbiological and clinical assessments; favorable responses required both favorable microbiological response (i.e., eradication or presumptive eradication based on symptoms, physical exam, and non-invasive tests) and complete or partial clinical response. | Of the 63 enrolled participants, one participant with invasive candidiasis who withdrew consent before completing the efficacy assessment was not included in the efficacy analyses. | Posted | Number | Participants | First dose of study drug through up to 60 days of therapy (maximum 28 days of study drug for esophageal candidiasis, 60 days for invasive candidiasis; mean treatment duration of 14 days) |
|
|
|
| 14 |
| 63 |
| 43 |
| 63 |
| Cardio-Respiratory Arrest | Cardiac disorders | MedDRA 14.0 |
|
| Vision Blurred | Eye disorders | MedDRA 14.0 |
|
| Death | General disorders | MedDRA 14.0 |
|
| Renal Failure | Renal and urinary disorders | MedDRA 14.0 |
|
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 |
|
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 |
|
| Circulatory Collapse | Vascular disorders | MedDRA 14.0 |
|
| Hypovolaemic Shock | Vascular disorders | MedDRA 14.0 |
|
| Shock | Vascular disorders | MedDRA 14.0 |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA 14.0 |
|
| Oedema | General disorders | MedDRA 14.0 |
|
| Pyrexia | General disorders | MedDRA 14.0 |
|
| Alanine Aminotransferase Increased | Investigations | MedDRA 14.0 |
|
| Aspartate Aminotransferase Increased | Investigations | MedDRA 14.0 |
|
| Blood Albumin Decreased | Investigations | MedDRA 14.0 |
|
| Blood Bilirubin Increased | Investigations | MedDRA 14.0 |
|
| Blood Calcium Decreased | Investigations | MedDRA 14.0 |
|
| Blood Creatinine Increased | Investigations | MedDRA 14.0 |
|
| Blood Glucose Increased | Investigations | MedDRA 14.0 |
|
| Blood Potassium Decreased | Investigations | MedDRA 14.0 |
|
| Blood Sodium Decreased | Investigations | MedDRA 14.0 |
|
| Blood Urea Increased | Investigations | MedDRA 14.0 |
|
| Protein Total Decreased | Investigations | MedDRA 14.0 |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 14.0 |
|
| Platelet Count Decreased | Investigations | MedDRA 14.0 |
|
Twenty-four months after completion of this study or after publication of the multicenter results, an investigator may publish the results for their study site independently. The sponsor must have the opportunity to review all proposed publications or presentations regarding the study 60 days before submission.
| D054714 |
| Echinocandins |
| D010456 | Peptides, Cyclic |