Trial · NCT00250432
A Multicenter, Randomized, Double-Blind, Comparative Study to Evaluate the Safety, Tolerability, and Efficacy of 2 Dosing Regimens of an Antifungal Drug in the Treatment of Fungal Infections in Adults (0991-801)(COMPLETED)
NCT00250432, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2009-03-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Multicenter, Randomized, Double-Blind, Comparative Study to Evaluate the Safety, Tolerability, and Efficacy of 2 Dosing Regimens of an Antifungal Drug in the Treatment of Fungal Infections in Adults (0991-801)(COMPLETED). Trials, record NCT00250432. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00250432
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Multicenter, Randomized, Double-Blind, Comparative Study to Evaluate the Safety, Tolerability, and Efficacy of 2 Dosing Regimens of an Antifungal Drug in the Treatment of Fungal Infections in Adults (0991-801)(COMPLETED)
- NCT number
- NCT00250432
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 204 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Invasive Candidiasis
- Interventions
- caspofungin acetate
- First posted
- 2005-11-08
- Last updated
- 2017-03-24
- Results first posted
- 2009-03-24
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients Who Develop Significant Drug-related Adverse Events. | 90 Days | Number of patients with at least 1 significant drug-related adverse event (serious drug-related or drug-related adverse events leading to caspofungin discontinuation) while on caspofungin study therapy or during the immediate 14-day post-caspofungin therapy period. |
| Secondary | Number of Patients With a Favorable Overall Response. | 90 Days | Number of patients with a favorable overall response, defined as a clinical response of "cure" or "apparent cure" along with a microbiological response of "eradication" or "presumptive eradication" at the End of Caspofungin Therapy. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients Who Develop Significant Drug-related Adverse Events. | 90 Days | All patients as treated population | Participants | NUMBER |
| SECONDARY | Number of Patients With a Favorable Overall Response. | 90 Days | Full Analysis Set (FAS): Included those patients who received at least 1 full dose of caspofungin study therapy and had a documented diagnosis of invasive candidiasis from a sterile, invasive body site, as defined in the protocol. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients Who Develop Significant Drug-related Adverse Events. | Caspofungin 70/50 mg | 2 | Participants | ||
| Number of Patients Who Develop Significant Drug-related Adverse Events. | Caspofungin 150 mg | 3 | Participants | ||
| Number of Patients With a Favorable Overall Response. | Caspofungin 70/50 mg | 73 | Participants | ||
| Number of Patients With a Favorable Overall Response. | Caspofungin 150 mg | 74 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Caspofungin 70/50 mg | 104 | |
| Overall Study | STARTED | Caspofungin 150 mg | 100 | |
| Overall Study | COMPLETED | Caspofungin 70/50 mg | 59 | |
| Overall Study | COMPLETED | Caspofungin 150 mg | 53 | |
| Overall Study | NOT COMPLETED | Caspofungin 70/50 mg | 45 | |
| Overall Study | NOT COMPLETED | Caspofungin 150 mg | 47 |
Source ClinicalTrials.gov
Adverse events326
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Caspofungin 70/50 mg | 3 | 104 | |
| other | Anaemia | Blood and lymphatic system disorders | Caspofungin 150 mg | 4 | 100 | |
| other | Atrial Fibrillation | Cardiac disorders | Caspofungin 70/50 mg | 0 | 104 | |
| other | Atrial Fibrillation | Cardiac disorders | Caspofungin 150 mg | 3 | 100 | |
| other | Bradycardia | Cardiac disorders | Caspofungin 70/50 mg | 2 | 104 | |
| other | Bradycardia | Cardiac disorders | Caspofungin 150 mg | 2 | 100 | |
| other | Tachycardia | Cardiac disorders | Caspofungin 70/50 mg | 1 | 104 | |
| other | Tachycardia | Cardiac disorders | Caspofungin 150 mg | 2 | 100 | |
| other | Ventricular Tachycardia | Cardiac disorders | Caspofungin 70/50 mg | 3 | 104 | |
| other | Ventricular Tachycardia | Cardiac disorders | Caspofungin 150 mg | 2 | 100 |
1 to 10 of 326Source ClinicalTrials.gov
See all 326 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Caspofungin 70/50 mg | ||
| Total, all-cause mortality | Caspofungin 150 mg | ||
| Total, other adverse events | Caspofungin 70/50 mg | 69 | |
| Total, other adverse events | Caspofungin 150 mg | 70 | |
| Total, serious adverse events | Caspofungin 70/50 mg | 46 | |
| Total, serious adverse events | Caspofungin 150 mg | 44 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 19419331 | BACKGROUND |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Caspofungin 70/50 mg vs Caspofungin 150 mg: Number of Patients Who Develop Significant Drug-related Adverse Events. | Trial comparisons |
| Caspofungin 70/50 mg vs Caspofungin 150 mg: Number of Patients With a Favorable Overall Response. | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00250432
GET https://conductscience.org/api/trials/v1/NCT00250432/events?page=2