Trial · NCT00721578
A Study Of Indian Patients Receiving Therapy For Systemic Fungal Infections
NCT00721578, Completed, Pfizer; results first posted 2010-08-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study Of Indian Patients Receiving Therapy For Systemic Fungal Infections. Trials, record NCT00721578. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00721578
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Of Indian Patients Receiving Therapy For Systemic Fungal Infections
- NCT number
- NCT00721578
- Status
- Completed
- Enrollment
- 23 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Systemic Fungal Infections
- Interventions
- voriconazole
- First posted
- 2008-07-24
- Last updated
- 2011-01-10
- Results first posted
- 2010-08-26
- Limitations and caveats
Primary and Secondary outcome measured were arbitrarily defined as they were not defined in the protocol.~This study was terminated prematurely due to slow recruitment rate leading to a small (23) number of subjects analyzed.
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Diagnosis of Systemic Fungal Infection (SFI) | Up to 9 months | Evidence of clinical signs and symptoms of systemic fungal infection including: fever, hypotension, or radiological or microbiological evidence, as assessed by the investigator. |
| Primary | Management of SFI: Choice of Treatment | Up to 9 months | Number of participants treated with each antifungal therapy. Each participant may have recieved 1 or more treatments as deemed clinically necessary by the investigator. |
| Primary | Management of SFI: Reason for Selection of Antifungal Agent | Up to 9 months | Number of participants with reason for investigator's selection of particular antifungal therapy. |
| Primary | Total Daily Dose for Selected Antifungal Agent | Up to 9 months | |
| Primary | Number of Participants With Clinical Outcomes. | Up to 9 months | Clinical outcomes, as assessed by the investigator, defined as: Cured: clinical signs and symptoms of fungal infection absent. Improved: clinical signs and symptoms of fungal infection improved. Stable: no change in overall clinical findings, compared with previous reporting period. Deteriorated: clinical signs and symptoms of fungal infection worsened (including death). Indeterminate; clinical signs and symptoms of fungal infection were insufficient to make an evaluation. |
| Primary | Number of Participants With Mycological Outcomes | Up to 9 months | Mycological outcome of persistence (continued presence of fungi on microbiology despite therapy), eradication (absence of fungi after therapy ), or unknown (results are not available/not known) as assessed by the Investigator/Physician. |
| Secondary | Concomitant Medications | Up to 9 months | |
| Secondary | Median Duration of Antifungal Therapy | Up to 9 months | |
| Secondary | Medication Administration | Up to 9 months | Participants who received medication by IV or oral administration, reported by total number of participants receiving IV and total number of participants receiving oral administation (overall), and by total number of participants receiving voriconazole only by IV or oral administration. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Diagnosis of Systemic Fungal Infection (SFI) | Up to 9 months | Full analysis set (FAS) = all enrolled participants who received at least one dose of antifungal therapy. n = number of participants who had microbiological assessments performed. SOT = start of treatment, EOT = end of treatment | Participants | NUMBER |
| PRIMARY | Management of SFI: Choice of Treatment | Up to 9 months | FAS. | Participants | NUMBER |
| PRIMARY | Management of SFI: Reason for Selection of Antifungal Agent | Up to 9 months | FAS. Data were not analyzed. | Participants | NUMBER |
| PRIMARY | Total Daily Dose for Selected Antifungal Agent | Up to 9 months | FAS. Data were not analyzed. | mg | NUMBER |
| PRIMARY | Number of Participants With Clinical Outcomes. | Up to 9 months | FAS. | Participants | NUMBER |
| PRIMARY | Number of Participants With Mycological Outcomes | Up to 9 months | FAS. | Participants | NUMBER |
| SECONDARY | Concomitant Medications | Up to 9 months | FAS. | Participants | NUMBER |
| SECONDARY | Median Duration of Antifungal Therapy | Up to 9 months | FAS. | Days | MEDIAN |
| SECONDARY | Medication Administration | Up to 9 months | FAS. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group125
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Diagnosis of Systemic Fungal Infection (SFI) | All Antifungal Therapies | Fever | 20 | Participants | |
| Diagnosis of Systemic Fungal Infection (SFI) | All Antifungal Therapies | Hypotension | 6 | Participants | |
| Diagnosis of Systemic Fungal Infection (SFI) | All Antifungal Therapies | Radiological Assessment (SOT - Abnormal) | 18 | Participants | |
| Diagnosis of Systemic Fungal Infection (SFI) | All Antifungal Therapies | Radiological Assessment (EOT - Abnormal) | 3 | Participants | |
| Diagnosis of Systemic Fungal Infection (SFI) | All Antifungal Therapies | Microbiological Assessment (positive, n=7) | 5 | Participants | |
| Diagnosis of Systemic Fungal Infection (SFI) | All Antifungal Therapies | Microbiological Assessment (negative, n=7) | 2 | Participants | |
| Management of SFI: Choice of Treatment | All Antifungal Therapies | Voriconazole | 12 | Participants | |
| Management of SFI: Choice of Treatment | All Antifungal Therapies | Fluconazole | 11 | Participants | |
| Management of SFI: Choice of Treatment | All Antifungal Therapies | Caspofungin acetate | 3 | Participants | |
| Management of SFI: Choice of Treatment | All Antifungal Therapies | Amphotericine B, liposome | 3 | Participants |
1 to 10 of 125Source ClinicalTrials.gov
See all 125 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Voriconazole Antifungal Treatment | 12 | |
| Overall Study | STARTED | Other Antifungal Treatment | 11 | |
| Overall Study | COMPLETED | Voriconazole Antifungal Treatment | 10 | |
| Overall Study | COMPLETED | Other Antifungal Treatment | 9 | |
| Overall Study | NOT COMPLETED | Voriconazole Antifungal Treatment | 2 | |
| Overall Study | NOT COMPLETED | Other Antifungal Treatment | 2 |
Source ClinicalTrials.gov
Adverse events12
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 | Vomiting | Gastrointestinal disorders | Therapy for Systemic Fungal Infections | 1 | 23 | |
| other | Urinary incontinence | Renal and urinary disorders | Therapy for Systemic Fungal Infections | 1 | 23 | |
| other | Decubitus ulcer | Skin and subcutaneous tissue disorders | Therapy for Systemic Fungal Infections | 1 | 23 | |
| serious | Pancreatitis | Gastrointestinal disorders | Therapy for Systemic Fungal Infections | 1 | 23 | |
| serious | Multi-organ failure | General disorders | Therapy for Systemic Fungal Infections | 3 | 23 | |
| serious | Sepsis | Infections and infestations | Therapy for Systemic Fungal Infections | 1 | 23 | |
| serious | Septic shock | Infections and infestations | Therapy for Systemic Fungal Infections | 2 | 23 | |
| serious | Coma | Nervous system disorders | Therapy for Systemic Fungal Infections | 1 | 23 | |
| serious | Somnolence | Nervous system disorders | Therapy for Systemic Fungal Infections | 1 | 23 | |
| serious | Azotaemia | Renal and urinary disorders | Therapy for Systemic Fungal Infections | 1 | 23 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Therapy for Systemic Fungal Infections | ||
| Total, other adverse events | Therapy for Systemic Fungal Infections | 3 | 23 |
| Total, serious adverse events | Therapy for Systemic Fungal Infections | 5 | 23 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT00721578
GET https://conductscience.org/api/trials/v1/NCT00721578/results?page=2