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The study has shown futility and the objectives could not be reached without enrolling a very large number of subjects.
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| Name | Class |
|---|---|
| Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) | INDUSTRY |
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The purpose of this study is to evaluate the benefits and side effects of daptomycin compared to placebo for the treatment of neutropenic fever.
To determine whether the percentage of neutropenic subjects that become afebrile by five days after fever first develops is higher when daptomycin compared to placebo is added at the same time as anti gram-negative therapy. The five day time point is selected because it is at this point where it is recommended to add antifungal therapy to the treatment regimen if the patient is still febrile.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Daptomycin | Active Comparator | Daptomycin intravenous 8mg/kg once per day 5-10 days. |
|
| Saline Placebo | Placebo Comparator | Saline solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daptomycin | Drug | 8 MG/KG IV |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Afebrile Neutropenic Subjects | To determine whether the percentage of neutropenic subjects that become afebrile by five days after fever first develops. | 5 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert F Betts, MD | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester Medical Center | Rochester | New York | 14642 | United States |
All subjects, once consent was obtained were considered enrolled. If they developed a fever they were then randomized to study drug or placebo. If they did not develop neutropenic fever they did not receive study drug or placebo.
First subject was enrolled on 14April2011 and last subject enrolled was 01November2012. All subjects were enrolled as inpatients at University of Rochester Medical Center.
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| ID | Title | Description |
|---|---|---|
| FG000 | Daptomycin | Daptomycin intravenous 8mg/kg once per day 5-10 days. Daptomycin : 8 mg/kg once daily Daptomycin : 8 MG/KG IV |
| FG001 | Saline Placebo | Saline solution Saline Placebo : 50 ml normal saline once daily Daptomycin : 8 mg/kg once daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Daptomycin | Daptomycin intravenous 8mg/kg once per day 5-10 days. Daptomycin : 8 mg/kg once daily Daptomycin : 8 MG/KG IV |
| BG001 | Saline Placebo | Saline solution Saline Placebo : 50 ml normal saline once daily Daptomycin : 8 mg/kg once daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | Percentage of Afebrile Neutropenic Subjects | To determine whether the percentage of neutropenic subjects that become afebrile by five days after fever first develops. | Posted | Number | participants | 5 days |
|
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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 | Daptomycin | Daptomycin intravenous 8mg/kg once per day 5-10 days. Daptomycin : 8 mg/kg once daily Daptomycin : 8 MG/KG IV |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| acute kidney injury | Renal and urinary disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| BK virus | Infections and infestations | Systematic Assessment |
It was felt that this study had shown futility and objectives could not be reached without enrolling a very large number of subjects in a reasonable time frame.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Robert F. Betts | University of Rochester | 585-275-5871 | robert_betts@urmc.rochester.edu |
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| ID | Term |
|---|---|
| D064147 | Febrile Neutropenia |
| ID | Term |
|---|---|
| D009503 | Neutropenia |
| D000380 | Agranulocytosis |
| D007970 | Leukopenia |
| D000095542 | Cytopenia |
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| ID | Term |
|---|---|
| D017576 | Daptomycin |
| ID | Term |
|---|---|
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D055666 | Lipopeptides |
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| Saline Placebo |
| Other |
50 ml normal saline once daily |
|
| Daptomycin | Drug | 8 mg/kg once daily |
|
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| 3 |
| 18 |
| 8 |
| 18 |
| EG001 | Saline Placebo | Saline solution Saline Placebo : 50 ml normal saline once daily Daptomycin : 8 mg/kg once daily | 2 | 18 | 5 | 18 |
| toxic epidermal necrolysis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| acute respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| hyperbilirubinemia | Hepatobiliary disorders | Systematic Assessment |
|
| elevated liver function tests | Hepatobiliary disorders | Systematic Assessment |
|
| CVC line infection | Infections and infestations | Systematic Assessment |
|
| clostridium difficile infection | Infections and infestations | Systematic Assessment |
|
| acute kidney injury | Renal and urinary disorders | Systematic Assessment |
|
| Mucositis | Gastrointestinal disorders | Systematic Assessment |
|
| Worsening throat pain | Gastrointestinal disorders | Systematic Assessment |
|
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Intermittent disorientation | Nervous system disorders | Systematic Assessment |
|
| Shaking | Nervous system disorders | Systematic Assessment |
|
| Confusion | Nervous system disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Fall | Nervous system disorders | Systematic Assessment |
|
| Occasional hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Tachypnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Hypotension | Cardiac disorders | Systematic Assessment |
|
| Swelling to left upper extremity | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| DVT to left basilic vein | Vascular disorders | Systematic Assessment |
|
| Hypernatremaia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Increased stool | Gastrointestinal disorders | Systematic Assessment |
|
| Worsening nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
|
| Ear fullness | Ear and labyrinth disorders | Systematic Assessment |
|
| Increased liver enzymes | Hepatobiliary disorders | Systematic Assessment |
|
| Worsening psoriasis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Rash on chest and neck | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Bruise to right arm | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Blister to arm | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Anal fissure | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Bony pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
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| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007960 | Leukocyte Disorders |
| D008055 |
| Lipids |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |