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Assessment of safety and efficacy of voriconazole in real-life setting in the treatment of high risk patients with invasive fungal infections. The study is conducted in Slovakia only.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Treatment | Patients who are eligible for voriconazole treatment according to their physician decision. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| voriconazole (VFEND®) | Drug | The use and dosage recommendations for voriconazole (VFEND®) will take place on the basis of the Summary of Product Characteristics (SmPC) and will be adjusted solely according to medical and therapeutic necessity. The formulation and dose will be managed by the treating physician according to the SmPC, disease and clinical situation. According to the SmPC, in the adults the treatment should be started with the loading dose of 6 mg/kg of voriconazole iv. every 12 hours (during the first 24 hrs) followed by the maintenance dose of 4 mg/kg BID. For peroral formulations, the initial dose should be depending on the weight of the patient 400 mg or 200 mg BID during the first 24 hrs, followed by the maintenance dose of 200 mg or 100 mg of voriconazole BID respectively For paediatric population (<12 years of age), there is no initial dose necessary. Depending on the formulation, the daily dosage should be in children 7 mg/kg iv. BID or 200 mg of voriconazole orally BID. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Clinical and/or Mycological Efficacy by Response at the End of Treatment (EOT) Visit | Clinical, mycological responses: clinical cure, clinical improvement, no clinical cure, mycological cure, no mycological cure, and no mycological culture performed. Participants could have had more than one response. Responses were based on the investigator's judgement according to the Infectious Disease Society of America, European Conference on Infections in Leukemia, and European Committee on Antimicrobial Susceptibility Testing guidelines. | up to 2 weeks (EOT visit) |
| Number of Participants With Clinical and/or Mycological Efficacy by Response at the Test-of-Cure Visit | Clinical, mycological responses: clinical cure, clinical improvement, no clinical cure, mycological cure, no mycological cure, no mycological culture performed, death, and lost from follow-up. Participants could have had more than one response. Responses were based on the investigator's judgement according to the Infectious Disease Society of America, European Conference on Infections in Leukemia, and European Committee on Antimicrobial Susceptibility Testing guidelines. | more than 2 weeks (Test-of-Cure visit) |
| Number of Participants With Investigator's Satisfaction With the Efficacy of Voriconazole Assessment at the EOT Visit | Investigator's Satisfaction Responses: very good, good, moderate, poor. Responses were based on the investigator's judgement. | up to 2 weeks (EOT visit) |
| Number of Participants With Investigator's Satisfaction With the Tolerability of Voriconazole Assessment at the EOT Visit | Investigator's Satisfaction Responses: very good, good, moderate, poor. Responses were based on the investigator's judgement. | up to 2 weeks (EOT visit) |
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Inclusion Criteria:
Exclusion Criteria:
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Male or female patients older than 2 years with invasive fungal infections.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Voriconazole | In adults, treatment was started with the loading dose of 6 mg/kg of voriconazole intravenously every 12 hours (during the first 24 hrs) followed by the maintenance dose of 4 mg/kg twice a day (BID). Adults with a weight of >40 kg receiving the oral formulation received a loading dose of 400 mg BID during the first 24 hours, followed by a maintenance dose of 200 mg BID for the duration of the study. Adults with a weight of <40 kg receiving the oral formulation received a loading dose of 200 mg BID during the first 24 hours, followed by a maintenance dose of 100 mg BID for the duration of the study. Pediatric participants under 12 years of age received 7 mg/kg IV BID or 200 mg orally BID for the duration of the study. A loading dose was not required in participants under 12 years of age. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Voriconazole | In adults, treatment was started with the loading dose of 6 mg/kg of voriconazole intravenously every 12 hours (during the first 24 hrs) followed by the maintenance dose of 4 mg/kg twice a day (BID). Adults with a weight of >40 kg receiving the oral formulation received a loading dose of 400 mg BID during the first 24 hours, followed by a maintenance dose of 200 mg BID for the duration of the study. Adults with a weight of <40 kg receiving the oral formulation received a loading dose of 200 mg BID during the first 24 hours, followed by a maintenance dose of 100 mg BID for the duration of the study. Pediatric participants under 12 years of age received 7 mg/kg IV BID or 200 mg orally BID for the duration of the study. A loading dose was not required in participants under 12 years of age. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Clinical and/or Mycological Efficacy by Response at the End of Treatment (EOT) Visit | Clinical, mycological responses: clinical cure, clinical improvement, no clinical cure, mycological cure, no mycological cure, and no mycological culture performed. Participants could have had more than one response. Responses were based on the investigator's judgement according to the Infectious Disease Society of America, European Conference on Infections in Leukemia, and European Committee on Antimicrobial Susceptibility Testing guidelines. | Full Analysis Set (FAS) = all enrolled participants who were administered the study medication and had post baseline documentation of efficacy available. | Posted | Number | participants | up to 2 weeks (EOT visit) |
|
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The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Voriconazole | In adults, treatment was started with the loading dose of 6 mg/kg of voriconazole intravenously every 12 hours (during the first 24 hrs) followed by the maintenance dose of 4 mg/kg twice a day (BID). Adults with a weight of >40 kg receiving the oral formulation received a loading dose of 400 mg BID during the first 24 hours, followed by a maintenance dose of 200 mg BID for the duration of the study. Adults with a weight of <40 kg receiving the oral formulation received a loading dose of 200 mg BID during the first 24 hours, followed by a maintenance dose of 100 mg BID for the duration of the study. Pediatric participants under 12 years of age received 7 mg/kg IV BID or 200 mg orally BID for the duration of the study. A loading dose was not required in participants under 12 years of age. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bone marrow disorder | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Liver disorder | Hepatobiliary disorders | MedDRA 12.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D000072742 | Invasive Fungal Infections |
| ID | Term |
|---|---|
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D065819 | Voriconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| Lost to Follow-up |
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| Other |
|
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Number of Participants Having Certain Methods of Diagnosis of Invasive Aspergillosis | Number | participants |
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| Number of Participants with Risk Factors of Invasive Fungal Infections | Number | participants |
|
|
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| Primary | Number of Participants With Clinical and/or Mycological Efficacy by Response at the Test-of-Cure Visit | Clinical, mycological responses: clinical cure, clinical improvement, no clinical cure, mycological cure, no mycological cure, no mycological culture performed, death, and lost from follow-up. Participants could have had more than one response. Responses were based on the investigator's judgement according to the Infectious Disease Society of America, European Conference on Infections in Leukemia, and European Committee on Antimicrobial Susceptibility Testing guidelines. | FAS. | Posted | Number | participants | more than 2 weeks (Test-of-Cure visit) |
|
|
|
| Primary | Number of Participants With Investigator's Satisfaction With the Efficacy of Voriconazole Assessment at the EOT Visit | Investigator's Satisfaction Responses: very good, good, moderate, poor. Responses were based on the investigator's judgement. | FAS. Number or participants analyzed = Number of participants with Investigator's satisfaction response for the efficacy of voriconazole at the EOT Visit. | Posted | Number | participants | up to 2 weeks (EOT visit) |
|
|
|
| Primary | Number of Participants With Investigator's Satisfaction With the Tolerability of Voriconazole Assessment at the EOT Visit | Investigator's Satisfaction Responses: very good, good, moderate, poor. Responses were based on the investigator's judgement. | FAS. Number or participants analyzed = Number of participants with Investigator's satisfaction response for the tolerability of voriconazole at the EOT Visit. | Posted | Number | participants | up to 2 weeks (EOT visit) |
|
|
|
| 34 |
| 177 |
| 6 |
| 177 |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
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| Acute myocardial infarction | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
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| Cardiac failure | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
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| Cardiopulmonary failure | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
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| Disease progression | General disorders | MedDRA 12.1 | Systematic Assessment |
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| Multi-organ failure | General disorders | MedDRA 12.1 | Systematic Assessment |
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| Sudden death | General disorders | MedDRA 12.1 | Systematic Assessment |
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| Aspergillosis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
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| Septic shock | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
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| Multiple injuries | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
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| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
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| Traumatic brain injury | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
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| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
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| Lymphocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
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| Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
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| Neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
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| Non-Hodgkin's lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
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| Haemorrhage intracranial | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
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| Haemorrhagic stroke | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
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| Locked-in syndrome | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
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| Crush syndrome | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
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| Nephropathy toxic | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
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| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Hypersensitivity | Immune system disorders | MedDRA 12.1 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
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| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
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| Acrodermatitis | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
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| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
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| Hypertensive crisis | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
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Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Measurements |
|---|---|
|
| Mycological Cure |
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| No Mycological Cure |
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| No Mycological Culture Performed |
|
| Death |
|
| Lost From Follow-Up |
|
| Title | Measurements |
|---|
|
| Poor |
|
| Title | Measurements |
|---|
|
| Poor |
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