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| Name | Class |
|---|---|
| European Society for Blood and Marrow Transplantation | NETWORK |
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To prevent recurrence of invasive fungal infection in patients with allogeneic stem cell transplants
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| voriconazole | Drug | Voriconazole is given to patients at least 48 hours after chemotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of Proven or Probable Invasive Fungal Infection (IFI): Start of Prophylaxis Until 12-month Follow-up Visit | Number of participants developing a proven or probable IFI from start of voriconazole prophylaxis until 12-month follow up | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of Proven or Probable Invasive Fungal Infection (IFI): Start of Prophylaxis Until 6-month Follow-up Visit | Number of participants developing a proven or probable IFI from start of voriconazole prophylaxis until 6-month follow up | 6 months |
| Occurrence of Proven or Probable Invasive Fungal Infection (IFI): Start of Voriconazole Prophylaxis Until End of Prophylaxis Visit |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Leuven | 3000 | Belgium | |||
| Pfizer Investigational Site |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Subjects with proven or probable Invasive Fungal Infection (IFI) in the previous 12 months, who were receiving an allogeneic Stem Cell Transplant (SCT) for any hematologic disease, were enrolled into the study if all other inclusion/exclusion criteria were met.
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| ID | Title | Description |
|---|---|---|
| FG000 | Voriconazole | All subjects received voriconazole as study medication for prophylaxis, for a minimum of 100 days after transplant. Subjects received an intravenous (IV; 6 mg/kg)) or oral (PO; 400 mg) loading dose every 12 hours (q12h) for 2 doses, followed by maintenance (i.e., prophylactic) doses of 4 mg/kg IV q12h or 200 mg PO q12h, if the subject weighed ≥40 kg. If the subject weighed <40 kg, the PO loading dose was 200 mg PO q12h for 2 doses, followed by maintenance doses of 100 mg PO q12h. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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Number of participants developing a proven or probable IFI from start of voriconazole prophylaxis until the End of Prophylaxis visit |
| 150 days |
| Time to Occurrence of Proven or Probable Invasive Fungal Infection (IFI) | Time to occurrence of proven or probable IFI from the start of voriconazole prophylaxis. Time to occurrence is strictly time to recorded diagnosis of IFI since the exact day on which the IFI began will not be known. | 12 months |
| Time to Occurrence of Proven or Probable New (New Pathogen) Invasive Fungal Infection (IFI) | Time to occurrence of proven or probable new (new pathogen) IFI from the start of voriconazole prophylaxis. Time to occurrence is strictly time to recorded diagnosis of IFI. | 12 months |
| Time to Occurrence of Proven or Probable Recurrent Invasive Fungal Infection (IFI) (Same Pathogen as Previous Baseline IFI) | Time to occurrence of proven or probable recurrent (same pathogen as baseline) IFI from the start of voriconazole prophylaxis. Time to occurrence is strictly time to recorded diagnosis of IFI. The pathogen identified as the positive culture recorded nearest to, but not after, the proven or probable IFI, was assumed to be responsible for the IFI. | 12 months |
| Survival Without Proven or Probable Invasive Fungal Infection (IFI) | Number of participants who survive (ie., are alive) without proven or probable IFI at each of the 6 and 12 month follow-up visits | 6 months, 12 months |
| Marseille |
| Cedex 09 |
| 13273 |
| France |
| Pfizer Investigational Site | Créteil | 94010 | France |
| Pfizer Investigational Site | Nantes | 44035 cedex | France |
| Pfizer Investigational Site | Pessac | 33600 | France |
| Pfizer Investigational Site | Strasbourg | 67098 | France |
| Pfizer Investigational Site | Cologne | 50937 | Germany |
| Pfizer Investigational Site | Mainz | 55101 | Germany |
| Pfizer Investigational Site | Würzburg | 97070 | Germany |
| Pfizer Investigational Site | Lisbon | Lisbon District | 1099-023 | Portugal |
| Pfizer Investigational Site | Barcelona | Barcelona | 08025 | Spain |
| Pfizer Investigational Site | Barcelona | Barcelona | 08036 | Spain |
| Pfizer Investigational Site | Madrid | Madrid | 28006 | Spain |
| Pfizer Investigational Site | Stockholm | 141 86 | Sweden |
| Pfizer Investigational Site | Ch-4031 Basel | Switzerland |
| Pfizer Investigational Site | London | W12 0NN | United Kingdom |
| Pfizer Investigational Site | Manchester | M20 4BX | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Voriconazole | All subjects received voriconazole as study medication for prophylaxis, for a minimum of 100 days after transplant. Subjects received an intravenous (IV; 6 mg/kg)) or oral (PO; 400 mg) loading dose every 12 hours (q12h) for 2 doses, followed by maintenance (i.e., prophylactic) doses of 4 mg/kg IV q12h or 200 mg PO q12h, if the subject weighed ≥40 kg. If the subject weighed <40 kg, the PO loading dose was 200 mg PO q12h for 2 doses, followed by maintenance doses of 100 mg PO q12h. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | Occurrence of Proven or Probable Invasive Fungal Infection (IFI): Start of Prophylaxis Until 12-month Follow-up Visit | Number of participants developing a proven or probable IFI from start of voriconazole prophylaxis until 12-month follow up | Complete case analysis (ie, outcome must be observed and/or subject must be evaluable for entire period of interest) using modified intent-to-treat (MITT) population (ie, subjects had at least 1 dose of voriconazole & at least 1 post-enrollment efficacy assessment & previous diagnosis of proven or probable IFI, confirmed by Data Review Committee). | Posted | Number | participants | 12 months |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Occurrence of Proven or Probable Invasive Fungal Infection (IFI): Start of Prophylaxis Until 6-month Follow-up Visit | Number of participants developing a proven or probable IFI from start of voriconazole prophylaxis until 6-month follow up | Complete case analysis (ie, outcome must be observed and/or subject must be evaluable for entire period of interest) using modified intent-to-treat (MITT) population (ie, subjects had at least 1 dose of voriconazole & at least 1 post-enrollment efficacy assessment & previous diagnosis of proven or probable IFI, confirmed by Data Review Committee). | Posted | Number | participants | 6 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Occurrence of Proven or Probable Invasive Fungal Infection (IFI): Start of Voriconazole Prophylaxis Until End of Prophylaxis Visit | Number of participants developing a proven or probable IFI from start of voriconazole prophylaxis until the End of Prophylaxis visit | Complete case analysis (ie, outcome must be observed and/or subject must be evaluable for entire period of interest) using modified intent-to-treat (MITT) population (ie, subjects had at least 1 dose of voriconazole & at least 1 post-enrollment efficacy assessment & previous diagnosis of proven or probable IFI, confirmed by Data Review Committee). | Posted | Number | participants | 150 days |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Occurrence of Proven or Probable Invasive Fungal Infection (IFI) | Time to occurrence of proven or probable IFI from the start of voriconazole prophylaxis. Time to occurrence is strictly time to recorded diagnosis of IFI since the exact day on which the IFI began will not be known. | Modified intent-to-treat (MITT) population (considered evaluable for efficacy) consisted of all subjects who had at least 1 dose of voriconazole & at least 1 post-enrollment efficacy assessment & had a previous diagnosis of proven or probable IFI, confirmed by the Data Review Committee. Three subjects in the MITT population experienced an IFI. | Posted | Number | days | 12 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Occurrence of Proven or Probable New (New Pathogen) Invasive Fungal Infection (IFI) | Time to occurrence of proven or probable new (new pathogen) IFI from the start of voriconazole prophylaxis. Time to occurrence is strictly time to recorded diagnosis of IFI. | Modified intent-to-treat (MITT) population (considered evaluable for efficacy) consisted of all subjects who had at least 1 dose of voriconazole & at least 1 post-enrollment efficacy assessment & had a previous diagnosis of proven or probable IFI, confirmed by the Data Review Committee. One subject in the MITT population experienced a new IFI. | Posted | Number | days | 12 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Occurrence of Proven or Probable Recurrent Invasive Fungal Infection (IFI) (Same Pathogen as Previous Baseline IFI) | Time to occurrence of proven or probable recurrent (same pathogen as baseline) IFI from the start of voriconazole prophylaxis. Time to occurrence is strictly time to recorded diagnosis of IFI. The pathogen identified as the positive culture recorded nearest to, but not after, the proven or probable IFI, was assumed to be responsible for the IFI. | Modified intent-to-treat (MITT) population (considered evaluable for efficacy) consisted of all subjects who had at least 1 dose of voriconazole & at least 1 post-enrollment efficacy assessment & had a previous diagnosis of proven or probable IFI, confirmed by the Data Review Committee. Two subjects experienced a recurrent proven or probable IFI. | Posted | Number | days | 12 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Survival Without Proven or Probable Invasive Fungal Infection (IFI) | Number of participants who survive (ie., are alive) without proven or probable IFI at each of the 6 and 12 month follow-up visits | Complete case analysis using MITT population (ie, all subjects who had at least 1 dose of study medication & at least 1 post-enrollment efficacy assessment & a previous diagnosis of proven or probable IFI, confirmed by Data Review Committee) & either provided an IFI assessment at follow-up visit, died or experienced an IFI before that visit. | Posted | Number | participants | 6 months, 12 months |
|
|
Not provided
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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 | All subjects received voriconazole as study medication for prophylaxis, for a minimum of 100 days after transplant. Subjects received an intravenous (IV; 6 mg/kg)) or oral (PO; 400 mg) loading dose every 12 hours (q12h) for 2 doses, followed by maintenance (i.e., prophylactic) doses of 4 mg/kg IV q12h or 200 mg PO q12h, if the subject weighed ≥40 kg. If the subject weighed <40 kg, the PO loading dose was 200 mg PO q12h for 2 doses, followed by maintenance doses of 100 mg PO q12h. | 23 | 45 | 42 | 45 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Acute myeloid leukaemia recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Blood creatine increased | Investigations | Systematic Assessment |
| ||
| Central nervous system leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Cholecystitis | Hepatobiliary disorders | Systematic Assessment |
| ||
| Cholestasis | Hepatobiliary disorders | Systematic Assessment |
| ||
| Cytomegalovirus infection | Infections and infestations | Systematic Assessment |
| ||
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Diarrhoea infectious | Infections and infestations | Systematic Assessment |
| ||
| Disease progression | General disorders | Systematic Assessment |
| ||
| Electrocardiogram change | Investigations | Systematic Assessment |
| ||
| Encephalitis herpes | Infections and infestations | Systematic Assessment |
| ||
| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Eye swelling | Eye disorders | Systematic Assessment |
| ||
| Facial paresis | Nervous system disorders | Systematic Assessment |
| ||
| Graft versus host disease | Immune system disorders | Systematic Assessment |
| ||
| Haemolysis | Blood and lymphatic system disorders | MedDRA v11.0 | Systematic Assessment |
| |
| Hallucination | Psychiatric disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Hepatitis toxic | Hepatobiliary disorders | Systematic Assessment |
| ||
| Hepatomegaly | Hepatobiliary disorders | Systematic Assessment |
| ||
| Hepatotoxicity | Hepatobiliary disorders | Systematic Assessment |
| ||
| Hyperbilirubinaemia | Hepatobiliary disorders | Systematic Assessment |
| ||
| Hyperglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypertension | Vascular disorders | Systematic Assessment |
| ||
| Hypotension | Vascular disorders | Systematic Assessment |
| ||
| Liver function test abnormal | Investigations | Systematic Assessment |
| ||
| Loss of consciousness | Nervous system disorders | Systematic Assessment |
| ||
| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Palpitations | Cardiac disorders | Systematic Assessment |
| ||
| Pancytopenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Systematic Assessment |
| ||
| Productive cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pyrexia | General disorders | Systematic Assessment |
| ||
| Renal failure | Renal and urinary disorders | Systematic Assessment |
| ||
| Sepsis | Infections and infestations | Systematic Assessment |
| ||
| Sputum culture positive | Investigations | Systematic Assessment |
| ||
| Tachycardia | Cardiac disorders | Systematic Assessment |
| ||
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Venoocclusive disease | Vascular disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Weight increased | Investigations | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA v11.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v11.0 | Systematic Assessment |
| |
| Acute graft versus host disease | Immune system disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA v11.0 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Chills | General disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Cholestasis | Hepatobiliary disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Chronic graft versus host disease | Immune system disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Cytomegalovirus infection | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v11.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA v11.0 | Systematic Assessment |
| |
| Graft versus host disease | Immune system disorders | MedDRA v11.0 | Systematic Assessment |
| |
| Hallucination | Psychiatric disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v11.0 | Systematic Assessment |
| |
| Hepatotoxicity | Hepatobiliary disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v11.0 | Systematic Assessment |
| |
| Transfusion reaction | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA v11.0 | Systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA (11.0) | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA V11.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v11.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v11.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v11.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v11.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (11.0) | Systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of < 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), < 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential info other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.govCallCenter@pfizer.com |
| ID | Term |
|---|---|
| D000072742 | Invasive Fungal Infections |
| D007938 | Leukemia |
| ID | Term |
|---|---|
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D065819 | Voriconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| 10 |
| 95 |
| 2 |
| 27 |
| No |
| Superiority or Other |
|
|
|
|
|
|
| Participants |
|
|
|
|