Trial · NCT00934934
Candida in the Respiratory Tract Secretions of Critically Ill Patients and The Efficacy of Antifungal Treatment
NCT00934934, Phase 2, Terminated, Daren K. Heyland; results first posted 2021-02-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Candida in the Respiratory Tract Secretions of Critically Ill Patients and The Efficacy of Antifungal Treatment. Trials, record NCT00934934. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00934934
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Candida in the Respiratory Tract Secretions of Critically Ill Patients and The Efficacy of Antifungal Treatment
- NCT number
- NCT00934934
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 61 participants, actual
- Lead sponsor
- Daren K. Heyland
- Conditions
- Ventilator Associated Pneumonia, Respiratory Tract Infection
- Interventions
- Normal Saline, anidulafungin
- First posted
- 2009-07-08
- Last updated
- 2021-02-01
- Results first posted
- 2021-02-01
- Limitations and caveats
We had an overall enrolment rate/month of 0.6 patients/site for the randomized trial. Consequently, recruitment was halted prematurely despite efforts to optimize enrolment because of difficulty in recruiting patients and diminishing study resources.
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Recruitment Rate | 32 months | Overall recruitment rate per site |
| Secondary | Duration of Stay in ICU | 28 days | Measure of the duration of participant stay in the ICU |
| Secondary | Ventilator Free Days | 28 days | Number of days in ICU free of ventilation |
| Secondary | ICU Free Days | 28 days | Number of days free of ICU |
| Secondary | Antibiotic Free Days 28-day Post Randomization | 28 days | Number of days free of antibiotic use within the first 28 days |
| Secondary | Hospital Length of Stay | 90 days | Measure of the duration of the participant's hospital stay |
| Secondary | (SOFA) Post Randomization | post randomization | Sequential organ failure assessment. 0-24 The higher the number the more severe organ failure |
| Secondary | Sequential Procalcitonin | 28 days | |
| Secondary | C-reactive Protein | 28 days | |
| Secondary | Interleukin-6 | 28 days |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Recruitment Rate | 32 months | This outcome measure was pre-specified to be for overall participants not by group. It was a reflection of how recruitment went for this protocol overall not by group. | participants per site /month | NUMBER |
| SECONDARY | Duration of Stay in ICU | 28 days | days | MEDIAN | |
| SECONDARY | Ventilator Free Days | 28 days | days | MEDIAN | |
| SECONDARY | ICU Free Days | 28 days | days | MEDIAN | |
| SECONDARY | Antibiotic Free Days 28-day Post Randomization | 28 days | days | MEDIAN | |
| SECONDARY | Hospital Length of Stay | 90 days | days | MEDIAN | |
| SECONDARY | (SOFA) Post Randomization | post randomization | score on a scale | MEAN | |
| SECONDARY | Sequential Procalcitonin | 28 days | ng/ml | MEAN | |
| SECONDARY | C-reactive Protein | 28 days | mg/l | MEAN | |
| SECONDARY | Interleukin-6 | 28 days | pg/ml | MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group21
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Recruitment Rate | Overall | 0.6 | participants per site /month | ||
| Duration of Stay in ICU | Placebo | 11.5 | Inter-Quartile Range 8 to 20 | days | |
| Duration of Stay in ICU | Antifungal | 13 | Inter-Quartile Range 8 to 28 | days | |
| Ventilator Free Days | Placebo | 8 | Inter-Quartile Range 6 to 11 | days | |
| Ventilator Free Days | Antifungal | 9 | Inter-Quartile Range 4 to 10 | days | |
| ICU Free Days | Placebo | 14 | Inter-Quartile Range 0 to 17 | days | |
| ICU Free Days | Antifungal | 4 | Inter-Quartile Range 0 to 17 | days | |
| Antibiotic Free Days 28-day Post Randomization | Placebo | 16 | Inter-Quartile Range 12 to 20 | days | |
| Antibiotic Free Days 28-day Post Randomization | Antifungal | 10 | Inter-Quartile Range 0 to 20 | days | |
| Hospital Length of Stay | Placebo | 29 | Inter-Quartile Range 17 to 38 | days |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 30 | |
| Overall Study | STARTED | Antifungal | 31 | |
| Overall Study | COMPLETED | Placebo | 29 | |
| Overall Study | COMPLETED | Antifungal | 31 | |
| Overall Study | NOT COMPLETED | Placebo | 1 | |
| Overall Study | NOT COMPLETED | Antifungal | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 0 |
| Total, all-cause mortality | Antifungal | 0 | 0 |
| Total, other adverse events | Placebo | 0 | 0 |
| Total, other adverse events | Antifungal | 0 | 0 |
| Total, serious adverse events | Placebo | 0 | 0 |
| Total, serious adverse events | Antifungal | 0 | 0 |
Source ClinicalTrials.gov
Papers28
The papers the trial lists on ClinicalTrials.gov.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00934934
GET https://conductscience.org/api/trials/v1/NCT00934934/results?page=2