FeverPhase 3NCT03768869
Fever and Neutropenia in Pediatric Oncology Patients
A Phase 3 study testing Low Risk: Oupatient Management, Low Risk: Inpatient Management and High Risk: Inpatient Management in people with Fever and Neutropenia, run by University of Colorado, Denver at 1 site in United States.
Trial summary
It is possible to distinguish between pediatric oncology patients who are at high or low risk for serious infection during periods of fever and treatment related neutropenia based on clinical parameters. Patients with low risk can be safely treated as outpatients primarily using oral antibiotics. Read more about this study
- Who is it for?
- Ages 0 to 21 years
- Conditions the study is for
- Fever, Neutropenia
- What is being tested?
- Low Risk: Oupatient Management, Low Risk: Inpatient Management and High Risk: Inpatient Management
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2006to 3 Apr 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 1. Any pediatric patient age <21 years with an oncology diagnosis who is undergoing therapy and is expected to have treatment related neutropenia.
Who cannot join
- 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.
- Any patient with a documented allergy to Levofloxacin or any other fluoroquinolone will be excluded.
- Patients with a known pregnancy will be excluded.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Colorado
Aurora, Colorado, 80045
About this study
Official title: Fever and Neutropenia in Pediatric Oncology Patients: A Randomized, Controlled, Multi-Center Study of Outpatient Therapy Evaluation of Genomic and Proteomic Correlates
It is possible to distinguish between pediatric oncology patients who are at high or low risk for serious infection during periods of fever and treatment related neutropenia based on clinical parameters. Patients with low risk can be safely treated as outpatients primarily using oral antibiotics. It is possible to improve methods of risk stratification through the addition of genomic and proteomic factors.
Read the detailed description
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.
- Conditions
- Fever, Neutropenia
- Being tested
- Low Risk: Oupatient Management, Low Risk: Inpatient Management, High Risk: Inpatient Management
- Keywords
- Pediatrics, Oncology, Outpatient therapy
- Medical subject headings
- Fever, Neutropenia, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Risk: Oupatient ManagementDrug
Also called Oral Antibiotics
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.
Low Risk: Inpatient ManagementDrug
Also called IV Antibiotics
Broad spectrum intravenous antibiotics. Daily blood work will be drawn, and patients will be monitored for fever and neutropenia in hospital.
High Risk: Inpatient ManagementDrug
Also called IV Antibiotics, High Risk
Broad spectrum intravenous antibiotics. Daily blood work will be drawn, and patients will be monitored for fever and neutropenia in hospital.
| Study group | Role | What they receive |
|---|---|---|
| Low Risk: Oupatient Management | Experimental | 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. Receives: Drug: Low Risk: Oupatient Management |
| Low Risk: Inpatient Management | Active comparator | 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. Receives: Drug: Low Risk: Inpatient Management |
| High Risk: Inpatient Management | Active comparator | 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. Receives: Drug: High Risk: Inpatient Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Low Risk Treatment
The response to initial antibiotic management without modification with regards to resolution of the episode of fever and neutropenia, measured through blood cultures
Measured: Start of study to end of study, up to two years
Protein Evaluation
Comparison of the level of each protein at the initiation of each episode versus resolution to determine if there is a pattern of proteins that correlates with an infectious outcome, measured using ELISA techniques
Measured: Start of study to end of study, up to two years
Genomics Evaluation
A comparison of proven infections between patients with the wild-type and variant forms of each gene studied, taken through DNA specimens
Measured: Start of study to end of study, up to two years
Secondary outcomes (3)
Cost Benefit Analysis
A cost-benefit analysis between the arms, duration of fever per episode between the arms, and number of admissions or deaths. Medical cost will be obtained through billing records and indirect costs will be estimated through information obtained from the family.
Measured: Start of study to end of study, up to two years
Protein Evaluation
Determine trends of protein markers on days 3 and 5 of evaluation, using ELISA techniques.
Measured: Start of study to end of study, up to two years
Genomics Evaluation
A comparison of the number of episodes of fever and neutropenia per patient and the duration of fever per episode between the wild type and variant forms of each gene, taken through DNA specimens.
Measured: Start of study to end of study, up to two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2018
- Study startFeb 2006
- Primary completion3 Apr 2009
- Study completion3 Apr 2009
Why it stopped: Insufficient data to answer the study question
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FeverStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be stratified as high risk, where they will receive inpatient management, or low risk, where they will then be randomize to receive inpatient or outpatient management.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kelly Maloney, MD, Principal investigator, Children's Hospital Colorado
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03768869
- Sponsor's protocol ID
- 05-0300.cc
- Status last verified
- Apr 2021
- First submitted
- 3 Dec 2018
- Last updated
- 27 Apr 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fever and Neutropenia in Pediatric Oncology Patients: A Randomized, Controlled, Multi-Center Study of Outpatient Therapy Evaluation of Genomic and Proteomic Correlates
- ClinicalTrials.gov ID
- NCT03768869
- Acronym / sponsor ID
- 05-0300.cc
- Conditions
- Fever, Neutropenia
- Keywords
- Pediatrics, Oncology, Outpatient therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Insufficient data to answer the study question
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Feb 2006 (actual)
- Primary completion
- 3 Apr 2009 (actual)
- Study completion
- 3 Apr 2009 (actual)
- First posted
- 7 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It is possible to distinguish between pediatric oncology patients who are at high or low risk for serious infection during periods of fever and treatment related neutropenia based on clinical parameters. Patients with low risk can be safely treated as outpatients primarily using oral antibiotics. It is possible to improve methods of risk stratification through the addition of genomic and proteomic factors.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Patients will be stratified as high risk, where they will receive inpatient management, or low risk, where they will then be randomize to receive inpatient or outpatient management.
| Arm | Type | Receives |
|---|---|---|
| Low Risk: Oupatient Management | Experimental | Drug: Low Risk: Oupatient ManagementPatients 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. |
| Low Risk: Inpatient Management | Active comparator | Drug: Low Risk: Inpatient ManagementPatients 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. |
| High Risk: Inpatient Management | Active comparator | Drug: High Risk: Inpatient ManagementPatients 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. |
Who may qualify
- Ages
- 0 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 1. Any pediatric patient age <21 years with an oncology diagnosis who is undergoing therapy and is expected to have treatment related neutropenia.
Key exclusion criteria (4 listed)
- 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.
- Any patient with a documented allergy to Levofloxacin or any other fluoroquinolone will be excluded.
- Patients with a known pregnancy will be excluded.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low Risk: Oupatient ManagementAlso: Oral AntibioticsIntravenous 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. | Drug | Low Risk: Oupatient Management |
| Low Risk: Inpatient ManagementAlso: IV AntibioticsBroad spectrum intravenous antibiotics. Daily blood work will be drawn, and patients will be monitored for fever and neutropenia in hospital. | Drug | Low Risk: Inpatient Management |
| High Risk: Inpatient ManagementAlso: IV Antibiotics, High RiskBroad spectrum intravenous antibiotics. Daily blood work will be drawn, and patients will be monitored for fever and neutropenia in hospital. | Drug | High Risk: Inpatient Management |
Primary outcome
Low Risk Treatment
Time frame: Start of study to end of study, up to two years
The response to initial antibiotic management without modification with regards to resolution of the episode of fever and neutropenia, measured through blood cultures
Protein Evaluation
Time frame: Start of study to end of study, up to two years
Comparison of the level of each protein at the initiation of each episode versus resolution to determine if there is a pattern of proteins that correlates with an infectious outcome, measured using ELISA techniques
Genomics Evaluation
Time frame: Start of study to end of study, up to two years
A comparison of proven infections between patients with the wild-type and variant forms of each gene studied, taken through DNA specimens
3 secondary outcomes
Cost Benefit Analysis
Time frame: Start of study to end of study, up to two years
Protein Evaluation
Time frame: Start of study to end of study, up to two years
Genomics Evaluation
Time frame: Start of study to end of study, up to two years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kelly Maloney, MD principal investigator
Children's Hospital Colorado
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Low Risk: Oupatient Management, Low Risk: Inpatient Management and High Risk: Inpatient Management in people with Fever and Neutropenia, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Low Risk Treatment (time frame: Start of study to end of study, up to two years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2021.