Systemic Fungal Infections
Conditions
Keywords
Observational study, Effectiveness, Safety, Tolerability, Systemic Fungal Infection
Brief 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.
Interventions
DRUGvoriconazole
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. The decision regarding choice of antifungal agent would lie with the treating physician and will necessarily precede and be independent of the decision to enroll a patient into the study.
Sponsors
Pfizer
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| Total Daily Dose for Selected Antifungal Agent | Up to 9 months | — |
| 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. |
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Median Duration of Antifungal Therapy | Up to 9 months | — |
| 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. |
| Concomitant Medications | Up to 9 months | — |
Countries
India
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Entire Study Population Systemic antifungals were administered based on approved prescribing documents and were adjusted solely according to medical and therapeutic necessity. The choice of systemic antifungal agent was dependent on the investigators decision and was independent of enrollment into the study | 23 |
| Total | 23 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Entire Study Population |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 7 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 3 / 23 |
| serious Total, serious adverse events | 5 / 23 |
Outcome results
Primary
Diagnosis of Systemic Fungal Infection (SFI)
Evidence of clinical signs and symptoms of systemic fungal infection including: fever, hypotension, or radiological or microbiological evidence, as assessed by the investigator.
Time frame: Up to 9 months
Population: 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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Antifungal Therapies | Diagnosis of Systemic Fungal Infection (SFI) | Fever | 20 Participants |
| All Antifungal Therapies | Diagnosis of Systemic Fungal Infection (SFI) | Hypotension | 6 Participants |
| All Antifungal Therapies | Diagnosis of Systemic Fungal Infection (SFI) | Radiological Assessment (SOT - Abnormal) | 18 Participants |
| All Antifungal Therapies | Diagnosis of Systemic Fungal Infection (SFI) | Radiological Assessment (EOT - Abnormal) | 3 Participants |
| All Antifungal Therapies | Diagnosis of Systemic Fungal Infection (SFI) | Microbiological Assessment (positive, n=7) | 5 Participants |
| All Antifungal Therapies | Diagnosis of Systemic Fungal Infection (SFI) | Microbiological Assessment (negative, n=7) | 2 Participants |
Primary
Management of SFI: Choice of Treatment
Number of participants treated with each antifungal therapy. Each participant may have recieved 1 or more treatments as deemed clinically necessary by the investigator.
Time frame: Up to 9 months
Population: FAS.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Antifungal Therapies | Management of SFI: Choice of Treatment | Voriconazole | 12 Participants |
| All Antifungal Therapies | Management of SFI: Choice of Treatment | Fluconazole | 11 Participants |
| All Antifungal Therapies | Management of SFI: Choice of Treatment | Caspofungin acetate | 3 Participants |
| All Antifungal Therapies | Management of SFI: Choice of Treatment | Amphotericine B, liposome | 3 Participants |
| All Antifungal Therapies | Management of SFI: Choice of Treatment | Amphotericin B | 2 Participants |
| All Antifungal Therapies | Management of SFI: Choice of Treatment | Caspofungin | 1 Participants |
Primary
Management of SFI: Reason for Selection of Antifungal Agent
Number of participants with reason for investigator's selection of particular antifungal therapy.
Time frame: Up to 9 months
Population: FAS. Data were not analyzed.
Primary
Number of Participants With Clinical Outcomes.
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.
Time frame: Up to 9 months
Population: FAS.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Antifungal Therapies | Number of Participants With Clinical Outcomes. | Cured | 2 Participants |
| All Antifungal Therapies | Number of Participants With Clinical Outcomes. | Improved | 11 Participants |
| All Antifungal Therapies | Number of Participants With Clinical Outcomes. | Stable | 6 Participants |
| All Antifungal Therapies | Number of Participants With Clinical Outcomes. | Deteriorated | 4 Participants |
Primary
Number of Participants With Mycological Outcomes
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.
Time frame: Up to 9 months
Population: FAS.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Antifungal Therapies | Number of Participants With Mycological Outcomes | Persistence | 3 Participants |
| All Antifungal Therapies | Number of Participants With Mycological Outcomes | Eradication | 8 Participants |
| All Antifungal Therapies | Number of Participants With Mycological Outcomes | Unknown | 11 Participants |
| All Antifungal Therapies | Number of Participants With Mycological Outcomes | Not Recorded | 1 Participants |
Primary
Total Daily Dose for Selected Antifungal Agent
Time frame: Up to 9 months
Population: FAS. Data were not analyzed.
Secondary
Concomitant Medications
Time frame: Up to 9 months
Population: FAS.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Antifungal Therapies | Concomitant Medications | Cefotaxime/sulbactam | 1 Participants |
| All Antifungal Therapies | Concomitant Medications | Ciprofloxacin | 1 Participants |
| All Antifungal Therapies | Concomitant Medications | Clindamycin | 2 Participants |
| All Antifungal Therapies | Concomitant Medications | Clopidogrel | 2 Participants |
| All Antifungal Therapies | Concomitant Medications | Colistin mesilate sodium | 2 Participants |
| All Antifungal Therapies | Concomitant Medications | Cordalin/old form/ | 2 Participants |
| All Antifungal Therapies | Concomitant Medications | Deflazacort | 1 Participants |
| All Antifungal Therapies | Concomitant Medications | Pheniramine maleate | 1 Participants |
| All Antifungal Therapies | Concomitant Medications | Acetorphan | 1 Participants |
| All Antifungal Therapies | Concomitant Medications | Acetylcysteine | 3 Participants |
| All Antifungal Therapies | Concomitant Medications | Acetylsalycilic acid | 2 Participants |
| All Antifungal Therapies | Concomitant Medications | Acetylsalicylic acid/clopidogrel | 1 Participants |
| All Antifungal Therapies | Concomitant Medications | Aciclovir | 1 Participants |
| All Antifungal Therapies | Concomitant Medications | Allopurinol | 1 Participants |
| All Antifungal Therapies | Concomitant Medications | Ambroxol | 1 Participants |
| All Antifungal Therapies | Concomitant Medications | Ambroxol Hydrochloride | 1 Participants |
| All Antifungal Therapies | Concomitant Medications | Amikacin | 4 Participants |
| All Antifungal Therapies | Concomitant Medications | Amiodarone Hydrochloride | 2 Participants |
| All Antifungal Therapies | Concomitant Medications | Amlodipine | 1 Participants |
| All Antifungal Therapies | Concomitant Medications | Atorvastatin | 1 Participants |
| All Antifungal Therapies | Concomitant Medications | Atracurium | 1 Participants |
| All Antifungal Therapies | Concomitant Medications | B-Komplex Leciva | 1 Participants |
| All Antifungal Therapies | Concomitant Medications | Breva | 1 Participants |
| All Antifungal Therapies | Concomitant Medications | Budesonide | 2 Participants |
| All Antifungal Therapies | Concomitant Medications | Carvedilol | 1 Participants |
| All Antifungal Therapies | Concomitant Medications | Cefazolin | 1 Participants |
| All Antifungal Therapies | Concomitant Medications | Cefepime | 1 Participants |
| All Antifungal Therapies | Concomitant Medications | Cefotaxime | 1 Participants |
| All Antifungal Therapies | Concomitant Medications | Diltiazem hydrochloride | 1 Participants |
| All Antifungal Therapies | Concomitant Medications | Doripenem | 1 Participants |
| All Antifungal Therapies | Concomitant Medications | Doxofylline | 1 Participants |
| All Antifungal Therapies | Concomitant Medications | Enalapril maleate | 1 Participants |
| All Antifungal Therapies | Concomitant Medications | Enoxaparin | 1 Participants |
| All Antifungal Therapies | Concomitant Medications | Epoetin alfa | 1 Participants |
| All Antifungal Therapies | Concomitant Medications | Escitalopram | 1 Participants |
| All Antifungal Therapies | Concomitant Medications | Esomeprazole | 2 Participants |
| All Antifungal Therapies | Concomitant Medications | Esomeprazole magnesium | 1 Participants |
| All Antifungal Therapies | Concomitant Medications | Ethambutol | 2 Participants |
| All Antifungal Therapies | Concomitant Medications | Fludrocortisone | 1 Participants |
| All Antifungal Therapies | Concomitant Medications | Fluoxetine hydrochloride | 1 Participants |
| All Antifungal Therapies | Concomitant Medications | Folic acid | 1 Participants |
| All Antifungal Therapies | Concomitant Medications | Folinic acid | 1 Participants |
| All Antifungal Therapies | Concomitant Medications | Furosemide | 2 Participants |
| All Antifungal Therapies | Concomitant Medications | Granulocyte colony stimulating factor | 1 Participants |
| All Antifungal Therapies | Concomitant Medications | Haloperidol | 2 Participants |
| All Antifungal Therapies | Concomitant Medications | Heparin-fraction, sodium salt | 6 Participants |
| All Antifungal Therapies | Concomitant Medications | Hydrocortisone | 1 Participants |
| All Antifungal Therapies | Concomitant Medications | Hydrocortisone hydrogen succinate | 4 Participants |
| All Antifungal Therapies | Concomitant Medications | Imipenem | 2 Participants |
| All Antifungal Therapies | Concomitant Medications | Immunoglobulins | 1 Participants |
| All Antifungal Therapies | Concomitant Medications | Insulin glargine | 1 Participants |
| All Antifungal Therapies | Concomitant Medications | Isoniazid | 1 Participants |
| All Antifungal Therapies | Concomitant Medications | Lactulose | 2 Participants |
| All Antifungal Therapies | Concomitant Medications | Lekovit ca | 2 Participants |
| All Antifungal Therapies | Concomitant Medications | Levetiracetam | 2 Participants |
| All Antifungal Therapies | Concomitant Medications | Levocetirizine | 1 Participants |
| All Antifungal Therapies | Concomitant Medications | Levofloxacin | 4 Participants |
| All Antifungal Therapies | Concomitant Medications | Linezolid | 4 Participants |
| All Antifungal Therapies | Concomitant Medications | Meropenem | 8 Participants |
| All Antifungal Therapies | Concomitant Medications | Methylprednisolone | 2 Participants |
| All Antifungal Therapies | Concomitant Medications | Metoclopramide hydrochloride | 3 Participants |
| All Antifungal Therapies | Concomitant Medications | Metronidazole | 5 Participants |
| All Antifungal Therapies | Concomitant Medications | Moxifloxacin | 1 Participants |
| All Antifungal Therapies | Concomitant Medications | Mycophenolate mofetil | 1 Participants |
| All Antifungal Therapies | Concomitant Medications | Ofloxacin | 1 Participants |
| All Antifungal Therapies | Concomitant Medications | Ondansetron | 4 Participants |
| All Antifungal Therapies | Concomitant Medications | Pantoprazole | 9 Participants |
| All Antifungal Therapies | Concomitant Medications | Pantoprazole sodium | 6 Participants |
| All Antifungal Therapies | Concomitant Medications | Paracetamol | 8 Participants |
| All Antifungal Therapies | Concomitant Medications | Pazufloxacin | 1 Participants |
| All Antifungal Therapies | Concomitant Medications | Phenobarbital | 1 Participants |
| All Antifungal Therapies | Concomitant Medications | Phenytoin sodium | 2 Participants |
| All Antifungal Therapies | Concomitant Medications | Pip/tazo | 1 Participants |
| All Antifungal Therapies | Concomitant Medications | Piperacillin | 1 Participants |
| All Antifungal Therapies | Concomitant Medications | Piperacillin/tazobactam | 4 Participants |
| All Antifungal Therapies | Concomitant Medications | Polybion | 2 Participants |
| All Antifungal Therapies | Concomitant Medications | Polymyxin B | 2 Participants |
| All Antifungal Therapies | Concomitant Medications | Polymyxin B sulfate | 3 Participants |
| All Antifungal Therapies | Concomitant Medications | Potassium | 2 Participants |
| All Antifungal Therapies | Concomitant Medications | Prednisolone | 2 Participants |
| All Antifungal Therapies | Concomitant Medications | Primaxin | 1 Participants |
| All Antifungal Therapies | Concomitant Medications | Propylthiouracil | 1 Participants |
| All Antifungal Therapies | Concomitant Medications | Prulifloxacin | 1 Participants |
| All Antifungal Therapies | Concomitant Medications | Pyridoxine | 1 Participants |
| All Antifungal Therapies | Concomitant Medications | Ramipril | 2 Participants |
| All Antifungal Therapies | Concomitant Medications | Ranolazine | 1 Participants |
| All Antifungal Therapies | Concomitant Medications | Ribolac | 1 Participants |
| All Antifungal Therapies | Concomitant Medications | Sertraline | 2 Participants |
| All Antifungal Therapies | Concomitant Medications | Simvastatin | 1 Participants |
| All Antifungal Therapies | Concomitant Medications | Solifenacin | 1 Participants |
| All Antifungal Therapies | Concomitant Medications | Sulperazon | 5 Participants |
| All Antifungal Therapies | Concomitant Medications | Teicoplanin | 11 Participants |
| All Antifungal Therapies | Concomitant Medications | Tienam | 1 Participants |
| All Antifungal Therapies | Concomitant Medications | Tramadol | 3 Participants |
| All Antifungal Therapies | Concomitant Medications | Valproic acid | 1 Participants |
| All Antifungal Therapies | Concomitant Medications | Vancomycin | 1 Participants |
| All Antifungal Therapies | Concomitant Medications | Vancomycin hydrochloride | 1 Participants |
| All Antifungal Therapies | Concomitant Medications | Vitamin B-complex | 1 Participants |
| All Antifungal Therapies | Concomitant Medications | Vitamin B12 (cyanocobalamin and derivatives) | 1 Participants |
Secondary
Median Duration of Antifungal Therapy
Time frame: Up to 9 months
Population: FAS.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| All Antifungal Therapies | Median Duration of Antifungal Therapy | Voriconazole | 13.0 Days |
| All Antifungal Therapies | Median Duration of Antifungal Therapy | All Antifungals | 12.0 Days |
Secondary
Medication Administration
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.
Time frame: Up to 9 months
Population: FAS.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Antifungal Therapies | Medication Administration | All Antifungals Intravenous | 17 Participants |
| All Antifungal Therapies | Medication Administration | All Antifungals Oral | 11 Participants |
| All Antifungal Therapies | Medication Administration | Voriconazole Intravenous | 5 Participants |
| All Antifungal Therapies | Medication Administration | Voriconazole Oral | 6 Participants |