Trial Outcomes & Findings for A Study of Caspofungin Acetate (MK0991) for the Treatment of Esophageal Candidiasis or Invasive Candidiasis in Chinese Adults (MK-0991-066) (NCT NCT00635648)
NCT ID: NCT00635648
Last Updated: 2017-03-24
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
63 participants
Primary outcome timeframe
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)
Results posted on
2017-03-24
Participant Flow
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
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63
|
|
Overall Study
COMPLETED
|
26
|
|
Overall Study
NOT COMPLETED
|
37
|
Reasons for withdrawal
| Measure |
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.
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|---|---|
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Overall Study
Adverse Event
|
12
|
|
Overall Study
Withdrawal by Subject
|
9
|
|
Overall Study
Physician Decision
|
4
|
|
Overall Study
Rapid progression of baseline disease
|
4
|
|
Overall Study
Use of other antifungal agent needed
|
1
|
|
Overall Study
No improvement after 7-10 days treatment
|
4
|
|
Overall Study
Noncompliance with protocol
|
1
|
|
Overall Study
Other reason
|
2
|
Baseline Characteristics
A Study of Caspofungin Acetate (MK0991) for the Treatment of Esophageal Candidiasis or Invasive Candidiasis in Chinese Adults (MK-0991-066)
Baseline characteristics by cohort
| Measure |
Caspofungin 50 mg q.d. Intravenous (IV)
n=63 Participants
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.
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|---|---|
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Age, Continuous
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50.4 years
STANDARD_DEVIATION 18.3 • n=5 Participants
|
|
Sex: Female, Male
Female
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24 Participants
n=5 Participants
|
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Sex: Female, Male
Male
|
39 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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)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.
Outcome measures
| Measure |
Caspofungin 50 mg q.d. IV
n=63 Participants
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.
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|---|---|
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Number of Participants With One or More Drug-related Serious Adverse Events
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0 Participants
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SECONDARY outcome
Timeframe: 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)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.
Outcome measures
| Measure |
Caspofungin 50 mg q.d. IV
n=63 Participants
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.
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|---|---|
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Number of Participants With One or More Drug-related Adverse Events
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31 Participants
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SECONDARY outcome
Timeframe: 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)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.
Outcome measures
| Measure |
Caspofungin 50 mg q.d. IV
n=63 Participants
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.
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|---|---|
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Number of Participants Who Discontinued Due to a Drug-related Adverse Event
|
1 Participants
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SECONDARY outcome
Timeframe: 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)Population: 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.
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.
Outcome measures
| Measure |
Caspofungin 50 mg q.d. IV
n=62 Participants
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.
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|---|---|
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Number of Participants With Favorable Overall Response for Esophageal Candidiasis or Invasive Candidiasis
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36 Participants
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Adverse Events
Caspofungin 50 mg q.d. IV
Serious events: 14 serious events
Other events: 43 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Caspofungin 50 mg q.d. IV
n=63 participants at risk
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.
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|---|---|
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Cardiac disorders
Cardiac Failure
|
1.6%
1/63 • Number of events 1 • 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)
|
|
Cardiac disorders
Cardio-Respiratory Arrest
|
1.6%
1/63 • Number of events 1 • 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)
|
|
Eye disorders
Vision Blurred
|
1.6%
1/63 • Number of events 1 • 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)
|
|
General disorders
Death
|
7.9%
5/63 • Number of events 5 • 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)
|
|
Renal and urinary disorders
Renal Failure
|
1.6%
1/63 • Number of events 1 • 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)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
1.6%
1/63 • Number of events 1 • 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)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
3.2%
2/63 • Number of events 2 • 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)
|
|
Vascular disorders
Circulatory Collapse
|
6.3%
4/63 • Number of events 4 • 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)
|
|
Vascular disorders
Hypovolaemic Shock
|
1.6%
1/63 • Number of events 1 • 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)
|
|
Vascular disorders
Shock
|
3.2%
2/63 • Number of events 2 • 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)
|
Other adverse events
| Measure |
Caspofungin 50 mg q.d. IV
n=63 participants at risk
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.
|
|---|---|
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Cardiac disorders
Cardiac Failure
|
6.3%
4/63 • Number of events 4 • 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)
|
|
Gastrointestinal disorders
Abdominal Pain
|
6.3%
4/63 • Number of events 4 • 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)
|
|
General disorders
Oedema
|
6.3%
4/63 • Number of events 4 • 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)
|
|
General disorders
Pyrexia
|
7.9%
5/63 • Number of events 7 • 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)
|
|
Investigations
Alanine Aminotransferase Increased
|
15.9%
10/63 • Number of events 10 • 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)
|
|
Investigations
Aspartate Aminotransferase Increased
|
14.3%
9/63 • Number of events 10 • 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)
|
|
Investigations
Blood Albumin Decreased
|
9.5%
6/63 • Number of events 6 • 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)
|
|
Investigations
Blood Bilirubin Increased
|
11.1%
7/63 • Number of events 11 • 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)
|
|
Investigations
Blood Calcium Decreased
|
7.9%
5/63 • Number of events 9 • 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)
|
|
Investigations
Blood Creatinine Increased
|
11.1%
7/63 • Number of events 8 • 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)
|
|
Investigations
Blood Glucose Increased
|
6.3%
4/63 • Number of events 4 • 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)
|
|
Investigations
Blood Potassium Decreased
|
39.7%
25/63 • Number of events 30 • 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)
|
|
Investigations
Blood Sodium Decreased
|
6.3%
4/63 • Number of events 4 • 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)
|
|
Investigations
Blood Urea Increased
|
7.9%
5/63 • Number of events 5 • 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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|
Investigations
Protein Total Decreased
|
9.5%
6/63 • Number of events 6 • 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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|
Skin and subcutaneous tissue disorders
Rash
|
7.9%
5/63 • Number of events 5 • 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)
|
|
Investigations
Platelet Count Decreased
|
7.9%
5/63 • Number of events 5 • 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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Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER