Adult Acute Lymphoblastic LeukemiaPhase 1NCT01484015
Prolonged or Standard Infusion of Cefepime Hydrochloride in Treating Patients With Febrile Neutropenia
A Phase 1 study testing cefepime hydrochloride in people with Adult Acute Lymphoblastic Leukemia and Adult Acute Myeloid Leukemia, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
This randomized pilot clinical trial studies how well giving prolonged infusion compared to standard infusion of cefepime hydrochloride works in treating patients with febrile neutropenia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult Acute Lymphoblastic Leukemia, Adult Acute Myeloid Leukemia, Adult Burkitt Lymphoma
- What is being tested?
- cefepime hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Oct 2012
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Absolute neutrophil count < 500 cells/mm^3 or < 1000 cells/mm^3 with a predicted decrease to < 500 cells/mm^3
- Temperature > 38.0 degrees Celsius
- Received chemotherapy or stem-cell transplant as treatment for malignancy or myelodysplastic syndrome (MDS)
- Cefepime prescribed at a dose of 2 grams IV every 8 hours
Who cannot join
- Allergy to a cephalosporin antibiotic
- Estimated creatinine clearance < 50 milliliters/minute
- Concurrent anti-gram negative antimicrobials
- Diagnostic criteria suggestive of sepsis
- Circumstances which may make 3 hour infusion impractical
- Solid tumor malignancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: Prolonged Infusion Compared to Standard Infusion Cefepime as Empiric Treatment of Febrile Neutropenia: A Pilot Study
This randomized pilot clinical trial studies how well giving prolonged infusion compared to standard infusion of cefepime hydrochloride works in treating patients with febrile neutropenia. Giving cefepime hydrochloride over a longer period of time may be more effective than giving cefepime hydrochloride over the standard time.
Read the detailed description
OBJECTIVES:
- The objective of this study is to describe outcomes associated with prolonged infusion (3 hours) compared to standard infusion (30 minutes) cefepime (cefepime hydrochloride) among patients being treated empirically for febrile neutropenia.
OUTLINE: Patients are randomized 1 of 2 treatment arms.
All patients receive cefepime hydrochloride intravenously (IV) over 30 minutes as their first dose.
ARM I: Patients receive cefepime hydrochloride intravenously (IV) over 30 minutes.
ARM II: Patients receive cefepime hydrochloride IV over 3 hours. Treatment repeats every 8 hours.
- Conditions
- Adult Acute Lymphoblastic Leukemia, Adult Acute Myeloid Leukemia, Adult Burkitt Lymphoma, Adult Diffuse Large Cell Lymphoma, Adult Diffuse Mixed Cell Lymphoma, Adult Diffuse Small Cleaved Cell Lymphoma
- Being tested
- cefepime hydrochloride
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myeloid, Acute, Burkitt Lymphoma, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Non-Hodgkin, Hodgkin Disease, Lymphoma, Large-Cell, Immunoblastic, Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cefepime hydrochlorideDrug
Also called cefepime, Maxipime
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Arm I (standard infusion) | Experimental | Patients receive cefepime hydrochloride IV over 30 minutes. Receives: Drug: cefepime hydrochloride |
| Arm II (prolonged infusion) | Experimental | Patients receive cefepime hydrochloride IV over 3 hours. Treatment repeats every 8 hours. Receives: Drug: cefepime hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Defervescence (without hypothermia)
Comparison between groups will be done using the chi square test. T-tests will be used for continues variables. Survival data will be estimated using the Kaplan-Meier method, with the formal test of group comparisons done using Cox's Proportional Hazards Model.
Measured: 72 hours
Secondary outcomes (6)
Clinical success or failure
Measured: approximately 24 days
Need for additional antimicrobials
Measured: approximately 24 days
Mortality (in-house)
Measured: approximately 24 days
Time to defervescence
Measured: approximately 24 days
Hospital length of stay
Measured: approximately 24 days
Successful treatment of baseline infection
Measured: approximately 24 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2011 (estimated)
- Study startFeb 2011
- Primary completionJun 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- John Williamson, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01484015
- Sponsor's protocol ID
- IRB00015247
- Other IDs
- NCI-2011-02422, CCCWFU 02110
- Status last verified
- Jul 2018
- First submitted
- 21 Oct 2011
- Last updated
- 18 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prolonged Infusion Compared to Standard Infusion Cefepime as Empiric Treatment of Febrile Neutropenia: A Pilot Study
- ClinicalTrials.gov ID
- NCT01484015
- Acronym / sponsor ID
- IRB00015247
- Conditions
- Adult Acute Lymphoblastic Leukemia, Adult Acute Myeloid Leukemia, Adult Burkitt Lymphoma, Adult Diffuse Large Cell Lymphoma, Adult Diffuse Mixed Cell Lymphoma, Adult Diffuse Small Cleaved Cell Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 2 Dec 2011 (estimated)
- 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.
This randomized pilot clinical trial studies how well giving prolonged infusion compared to standard infusion of cefepime hydrochloride works in treating patients with febrile neutropenia. Giving cefepime hydrochloride over a longer period of time may be more effective than giving cefepime hydrochloride over the standard time.
Detailed description
OBJECTIVES:
- The objective of this study is to describe outcomes associated with prolonged infusion (3 hours) compared to standard infusion (30 minutes) cefepime (cefepime hydrochloride) among patients being treated empirically for febrile neutropenia.
OUTLINE: Patients are randomized 1 of 2 treatment arms.
All patients receive cefepime hydrochloride intravenously (IV) over 30 minutes as their first dose.
ARM I: Patients receive cefepime hydrochloride intravenously (IV) over 30 minutes.
ARM II: Patients receive cefepime hydrochloride IV over 3 hours. Treatment repeats every 8 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (standard infusion) | Experimental | Drug: cefepime hydrochloridePatients receive cefepime hydrochloride IV over 30 minutes. |
| Arm II (prolonged infusion) | Experimental | Drug: cefepime hydrochloridePatients receive cefepime hydrochloride IV over 3 hours. Treatment repeats every 8 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Absolute neutrophil count < 500 cells/mm^3 or < 1000 cells/mm^3 with a predicted decrease to < 500 cells/mm^3
- Temperature > 38.0 degrees Celsius
- Received chemotherapy or stem-cell transplant as treatment for malignancy or myelodysplastic syndrome (MDS)
- Cefepime prescribed at a dose of 2 grams IV every 8 hours
Key exclusion criteria (6 listed)
- Allergy to a cephalosporin antibiotic
- Estimated creatinine clearance < 50 milliliters/minute
- Concurrent anti-gram negative antimicrobials
- Diagnostic criteria suggestive of sepsis
- Circumstances which may make 3 hour infusion impractical
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 |
|---|---|---|
| cefepime hydrochlorideAlso: cefepime, MaxipimeGiven IV | Drug | Arm I (standard infusion), Arm II (prolonged infusion) |
Primary outcome
Defervescence (without hypothermia)
Time frame: 72 hours
Comparison between groups will be done using the chi square test. T-tests will be used for continues variables. Survival data will be estimated using the Kaplan-Meier method, with the formal test of group comparisons done using Cox's Proportional Hazards Model.
6 secondary outcomes
Clinical success or failure
Time frame: approximately 24 days
Need for additional antimicrobials
Time frame: approximately 24 days
Mortality (in-house)
Time frame: approximately 24 days
Time to defervescence
Time frame: approximately 24 days
Hospital length of stay
Time frame: approximately 24 days
Successful treatment of baseline infection
Time frame: approximately 24 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2018.
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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.
John Williamson principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing cefepime hydrochloride in people with Adult Acute Lymphoblastic Leukemia and Adult Acute Myeloid Leukemia, run by Wake Forest University Health Sciences 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 18 Jul 2018. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Defervescence (without hypothermia) (time frame: 72 hours). 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 18 Jul 2018.