A Phase 3 interventional study of caspofungin acetate in Fungal Infection, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-03-24.
Sponsored by Merck Sharp & Dohme LLC · Phase 3, Interventional, and Treatment
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.
265 studies on the registry are indexed under Candidiasis; 20 are open to participants now.
This study's enrollment of 63 is below the median of 99 across 186 interventional studies indexed under Candidiasis.
Browse Candidiasis studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.
Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
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
Drug: caspofungin acetate
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.
Also known as: MK0991, Cancidas®
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.
Time frame: 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 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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
| Milestone | Caspofungin 50 mg q.d. Intravenous (IV) |
|---|---|
| Started | 63 |
| Completed | 26 |
| Not completed | 37 |
| Withdrew: Adverse event | 12 |
| Withdrew: Withdrawal by subject | 9 |
| Withdrew: Physician decision | 4 |
| Withdrew: Rapid progression of baseline disease | 4 |
| Withdrew: Use of other antifungal agent needed | 1 |
| Withdrew: No improvement after 7-10 days treatment | 4 |
| Withdrew: Noncompliance with protocol | 1 |
| Withdrew: Other reason | 2 |
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.
| Participants | Caspofungin 50 mg q.d. IV |
|---|---|
| Number of Participants With One or More Drug-related Serious Adverse Events | 0 |
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.
| Participants | Caspofungin 50 mg q.d. IV |
|---|---|
| Number of Participants With One or More Drug-related Adverse Events | 31 |
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.
| Participants | Caspofungin 50 mg q.d. IV |
|---|---|
| Number of Participants Who Discontinued Due to a Drug-related Adverse Event | 1 |
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.
| Participants | Caspofungin 50 mg q.d. IV |
|---|---|
| Number of Participants With Favorable Overall Response for Esophageal Candidiasis or Invasive Candidiasis | 36 |
Collected over 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). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Caspofungin 50 mg q.d. IV | — | 14/63 (22.2%) | 43/63 (68.3%) |
| Event | Caspofungin 50 mg q.d. IV |
|---|---|
| DeathGeneral disorders | 5/63 |
| Circulatory CollapseVascular disorders | 4/63 |
| Respiratory FailureRespiratory, thoracic and mediastinal disorders | 2/63 |
| ShockVascular disorders | 2/63 |
| Cardiac FailureCardiac disorders | 1/63 |
| Cardio-Respiratory ArrestCardiac disorders | 1/63 |
| Vision BlurredEye disorders | 1/63 |
| Renal FailureRenal and urinary disorders | 1/63 |
| Pulmonary EmbolismRespiratory, thoracic and mediastinal disorders | 1/63 |
| Hypovolaemic ShockVascular disorders | 1/63 |
| Event | Caspofungin 50 mg q.d. IV |
|---|---|
| Blood Potassium DecreasedInvestigations | 25/63 |
| Alanine Aminotransferase IncreasedInvestigations | 10/63 |
| Aspartate Aminotransferase IncreasedInvestigations | 9/63 |
| Blood Bilirubin IncreasedInvestigations | 7/63 |
| Blood Creatinine IncreasedInvestigations | 7/63 |
| Blood Albumin DecreasedInvestigations | 6/63 |
| Protein Total DecreasedInvestigations | 6/63 |
| PyrexiaGeneral disorders | 5/63 |
| Blood Calcium DecreasedInvestigations | 5/63 |
| Blood Urea IncreasedInvestigations | 5/63 |
| Age, Continuous(years) | Caspofungin 50 mg q.d. Intravenous (IV) |
|---|---|
| Mean | 50.4 ± 18.3 |
| Sex: Female, Male(Participants) | Caspofungin 50 mg q.d. Intravenous (IV) |
|---|---|
| Female | 24 |
| Male | 39 |
No study locations are listed for this record.
Plan to share: Yes — http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php
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Merck Sharp & Dohme LLC