N/A
N=23
A Study Of Indian Patients Receiving Therapy For Systemic Fungal Infections
Systemic Fungal Infections
Bottom Line
View on ClinicalTrials.gov: NCT00721578 ↗Enrolled (actual)
23
Serious AEs
21.7%
Results posted
Aug 2010
Primary outcome: Primary: Diagnosis of Systemic Fungal Infection (SFI) — 20; 6; 18; 3 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- voriconazole (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Diagnosis of Systemic Fungal Infection (SFI) |
20; 6; 18; 3; 5; 2 | — |
| PRIMARY Management of SFI: Choice of Treatment |
12; 11; 3; 3; 2; 1 | — |
| PRIMARY Management of SFI: Reason for Selection of Antifungal Agent |
— | — |
| PRIMARY Total Daily Dose for Selected Antifungal Agent |
— | — |
| PRIMARY Number of Participants With Clinical Outcomes. |
2; 11; 6; 4 | — |
| PRIMARY Number of Participants With Mycological Outcomes |
3; 8; 11; 1 | — |
| SECONDARY Concomitant Medications |
1; 3; 2; 1; 1; 1 | — |
| SECONDARY Median Duration of Antifungal Therapy |
12.0; 13.0 | — |
| SECONDARY Medication Administration |
17; 11; 5; 6 | — |
Summary
To collect and summarize information on the diagnosis, management, and clinical and mycological outcomes of patients with systemic fungal infections in order to better understand the effectiveness of antifungals in the treatment of Systemic Fungal Infections (SFI) in India.
Eligibility Criteria
Inclusion Criteria
- To be eligible for enrollment in the study database, patients must have received (in the Intensive Care Unit [ICU] at study entry) at least 1 day therapy with systemic antifungal agent for treatment of a proven or suspected fungal infection.
Exclusion Criteria
- None.
Data sourced from ClinicalTrials.gov (NCT00721578). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.