Fever and Neutropenia in Pediatric Oncology Patients
关键词
抽象
描述
Outpatient management of patients considered to be at low risk for serious bacterial infection has been explored using risk stratification schema based on clinical parameters. First, patients will be stratified based on a clinical risk stratification schema. Patients stratified to the low risk group will be randomized between treatment using standard inpatient intravenous antibiotic therapy or outpatient antibiotic therapy using primarily an oral regimen. Second, an evaluation of proteins important to the innate immune system will be performed to provide a molecular characterization of episodes based on etiology. Third, single nucleotide polymorphisms in genes important for innate immunity will be evaluated to determine effect of each on infection risk during treatment induced neutropenia. Finally, we will develop a bank of both plasma and DNA specimens correlated with clinical outcomes for future use.
日期
| 最后验证: | 08/31/2019 |
| 首次提交: | 12/02/2018 |
| 提交的预估入学人数: | 12/04/2018 |
| 首次发布: | 12/06/2018 |
| 上次提交的更新: | 09/04/2019 |
| 最近更新发布: | 09/05/2019 |
| 实际学习开始日期: | 01/31/2006 |
| 预计主要完成日期: | 04/02/2009 |
| 预计完成日期: | 02/29/2020 |
状况或疾病
干预/治疗
Drug: Low Risk: Oupatient Management
Drug: Low Risk: Inpatient Management
Drug: High Risk: Inpatient Management
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: Low Risk: Oupatient Management Patients will be categorized according to risk of serious bacterial infection per risk stratification system, which is based on demographic, clinical history and physical findings that have been shown to be predictive of risk. | Drug: Low Risk: Oupatient Management Intravenous Levaquin initially, then oral dosing. Patient discharged to go home to finish medication cycle after initial 120 minutes observation. Patients will be evaluated daily in the clinic, and his or her temperature must be taken and recorded four times per day. Blood cultures will be drawn at clinic visits. |
| Active Comparator: Low Risk: Inpatient Management Patients will be categorized according to risk of serious bacterial infection per risk stratification system, which is based on demographic, clinical history and physical findings that have been shown to be predictive of risk. | Drug: Low Risk: Inpatient Management Broad spectrum intravenous antibiotics. Daily blood work will be drawn, and patients will be monitored for fever and neutropenia in hospital. |
| Active Comparator: High Risk: Inpatient Management Patients will be categorized according to risk of serious bacterial infection per risk stratification system, which is based on demographic, clinical history and physical findings that have been shown to be predictive of risk. | Drug: High Risk: Inpatient Management Broad spectrum intravenous antibiotics. Daily blood work will be drawn, and patients will be monitored for fever and neutropenia in hospital. |
资格标准
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: 1. Any pediatric patient age <21 years with an oncology diagnosis who is undergoing therapy and is expected to have treatment related neutropenia. Exclusion Criteria: 1. Any patient who has previously undergone autologous or allogeneic bone marrow transplant will be excluded from study enrollment. If a patient is expected to undergo autologous or allogeneic bone marrow transplant as part of therapy at some point after enrollment in the study he/she will be removed from the study at the start of their bone marrow transplant. 2. Any patient with a documented allergy to Levofloxacin or any other fluoroquinolone will be excluded. 3. Patients with a known pregnancy will be excluded. 4. Any patient with an underlying chronic musculoskeletal condition (ie Juvenile rheumatoid arthritis, Systemic lupus erythematosis etc) which may make evaluation for joint toxicity related to quinolone treatment difficult. |
结果
主要结果指标
1. Low Risk Treatment [Start of study to end of study, up to two years]
2. Protein Evaluation [Start of study to end of study, up to two years]
3. Genomics Evaluation [Start of study to end of study, up to two years]
次要成果指标
1. Cost Benefit Analysis [Start of study to end of study, up to two years]
2. Protein Evaluation [Start of study to end of study, up to two years]
3. Genomics Evaluation [Start of study to end of study, up to two years]
