Trial · NCT01945281
Safety, Tolerability, and Efficacy of Caspofungin Versus Amphotericin B Deoxycholate in the Treatment of Invasive Candidiasis in Neonates and Infants (MK-0991-064)
NCT01945281, Phase 2, Terminated, Merck Sharp & Dohme LLC; results first posted 2018-08-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety, Tolerability, and Efficacy of Caspofungin Versus Amphotericin B Deoxycholate in the Treatment of Invasive Candidiasis in Neonates and Infants (MK-0991-064). Trials, record NCT01945281. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01945281
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety, Tolerability, and Efficacy of Caspofungin Versus Amphotericin B Deoxycholate in the Treatment of Invasive Candidiasis in Neonates and Infants (MK-0991-064)
- NCT number
- NCT01945281
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 51 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Candidiasis, Invasive
- Interventions
- Caspofungin, Amphotericin B Deoxycholate
- First posted
- 2013-09-18
- Last updated
- 2019-11-25
- Other registries' IDs
- eudract:2013-002084-26
- Results first posted
- 2018-08-28
- Limitations and caveats
- The trial was terminated early due to operational feasibility with low recruitment due to changing epidemiology of disease.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Fungal-free Survival Through the 2-week Post-therapy Period | Up to 104 days | Fungal-free survival is those participants who survived up to 2 weeks post-therapy, and had documented microbiological eradication of Candida species (sp.) from follow-up cultures collected after the initiation of study therapy. Microbiological eradication denotes negative follow-up cultures for Candida sp. from the site of infection. If a culture is not obtained on the day of assessment, the last culture after study entry may be used to assist in the assessment of microbiological eradication. If the last culture is negative for Candida sp., then microbiological eradication would be considered achieved. |
| Secondary | Percentage of Participants With Fungal-free Survival Through the End of Study Treatment | Up to 90 days | Fungal-free survival is those participants who survived up to end of study treatment, and had documented microbiological eradication of Candida sp. from follow-up cultures collected after the initiation of study therapy. Microbiological eradication denotes negative follow-up cultures for Candida sp. from the site of infection. If a culture is not obtained on the day of assessment, the last culture after study entry may be used to assist in the assessment of microbiological eradication. If the last culture is negative for Candida sp., then microbiological eradication would be considered achieved. |
| Secondary | Number of Participants With an Adverse Event (AE) | 8 weeks after end of study therapy (up to 146 days) | An AE is any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product, is also an AE. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Fungal-free Survival Through the 2-week Post-therapy Period | Up to 104 days | Participants who received at least 1 full dose of study therapy and had a documented (culture-confirmed) diagnosis of invasive candidiasis. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Fungal-free Survival Through the End of Study Treatment | Up to 90 days | Participants who received at least 1 full dose of study therapy and had a documented (culture-confirmed) diagnosis of invasive candidiasis. | Percentage of Participants | NUMBER |
| SECONDARY | Number of Participants With an Adverse Event (AE) | 8 weeks after end of study therapy (up to 146 days) | All participants as treated | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Fungal-free Survival Through the 2-week Post-therapy Period | Caspofungin | 71.0 | 95% Confidence Interval 52.0 to 85.8 | Percentage of Participants | |
| Percentage of Participants With Fungal-free Survival Through the 2-week Post-therapy Period | Amphotericin B Deoxycholate | 68.8 | 95% Confidence Interval 41.3 to 89.0 | Percentage of Participants | |
| Percentage of Participants With Fungal-free Survival Through the End of Study Treatment | Caspofungin | 71.0 | 95% Confidence Interval 52.0 to 85.8 | Percentage of Participants | |
| Percentage of Participants With Fungal-free Survival Through the End of Study Treatment | Amphotericin B Deoxycholate | 75.0 | 95% Confidence Interval 47.6 to 92.7 | Percentage of Participants | |
| Number of Participants With an Adverse Event (AE) | Caspofungin | 28 | Participants | ||
| Number of Participants With an Adverse Event (AE) | Amphotericin B Deoxycholate | 16 | Participants |
Source ClinicalTrials.gov
Participant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Caspofungin | 34 | |
| Overall Study | STARTED | Amphotericin B Deoxycholate | 17 | |
| Overall Study | Treated | Caspofungin | 33 | |
| Overall Study | Treated | Amphotericin B Deoxycholate | 16 | |
| Overall Study | COMPLETED | Caspofungin | 28 | |
| Overall Study | COMPLETED | Amphotericin B Deoxycholate | 13 | |
| Overall Study | NOT COMPLETED | Caspofungin | 6 | |
| Overall Study | NOT COMPLETED | Amphotericin B Deoxycholate | 4 |
Source ClinicalTrials.gov
Adverse events154
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 | 10 | 33 | 16 |
| other | Anaemia | Blood and lymphatic system disorders | Amphotericin B Deoxycholate | 8 | 16 | 12 |
| other | Leukostasis syndrome | Blood and lymphatic system disorders | Caspofungin | 0 | 33 | 0 |
| other | Leukostasis syndrome | Blood and lymphatic system disorders | Amphotericin B Deoxycholate | 1 | 16 | 1 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Caspofungin | 0 | 33 | 0 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Amphotericin B Deoxycholate | 1 | 16 | 1 |
| other | Bradycardia | Cardiac disorders | Caspofungin | 0 | 33 | 0 |
| other | Bradycardia | Cardiac disorders | Amphotericin B Deoxycholate | 2 | 16 | 3 |
| other | Tachycardia | Cardiac disorders | Caspofungin | 2 | 33 | 2 |
| other | Tachycardia | Cardiac disorders | Amphotericin B Deoxycholate | 2 | 16 | 2 |
1 to 10 of 154Source ClinicalTrials.gov
See all 154 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Caspofungin | 2 | 33 |
| Total, all-cause mortality | Amphotericin B Deoxycholate | 3 | 16 |
| Total, other adverse events | Caspofungin | 23 | 33 |
| Total, other adverse events | Amphotericin B Deoxycholate | 15 | 16 |
| Total, serious adverse events | Caspofungin | 7 | 33 |
| Total, serious adverse events | Amphotericin B Deoxycholate | 9 | 16 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31586424 | RESULT |
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Caspofungin vs Amphotericin B Deoxycholate: Number of Participants With an Adverse Event (AE) | Trial comparisons |
| Caspofungin vs Amphotericin B Deoxycholate: deaths from any cause | Trial comparisons |
| Caspofungin vs Amphotericin B Deoxycholate: serious adverse events | 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/NCT01945281
GET https://conductscience.org/api/trials/v1/NCT01945281/events?page=2