FeverPhase 2NCT00335478
Daptomycin in Treating Neutropenia and Fever in Patients With Cancer
A Phase 2 study testing Daptomycin in people with Fever and Sweating, run by OHSU Knight Cancer Institute at 1 site in United States.
Trial summary
RATIONALE: Antibiotics, such as daptomycin, may control neutropenia, fever, and infection in patients with cancer. PURPOSE: This phase II trial is studying how well daptomycin works in treating neutropenia and fever in patients with cancer. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Fever, Sweating, Hot Flashes
- What is being tested?
- Daptomycin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2006to Oct 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Diagnosis of cancer
- Diagnosis of neutropenic fever
- Temperature > 38.3°C once OR ≥ 38°C twice within 12 hours
- Absolute neutrophil count < 500/mm^³ and ≥ 1 of the following:
- Mucositis
- Concurrent skin or soft tissue infection
- Indwelling catheter and/or suspected catheter infection
- Recent quinolone prophylaxis
- Positive blood cultures for gram-positive cocci before final identification or other documented gram-positive pathogen
- Colonization with β-lactam resistant gram-positive organisms (commonly the nares or the skin)
- Hypotension, tachycardia, narrowed pulse pressures, tachypnea, or other signs of cardiovascular compromise
- Expected duration of neutropenia ≥ 3 days
- No known infection with daptomycin-resistant organism or gram-negative organism and not yet meeting criteria for the addition of gram-positive antimicrobial therapy
- No suspected meningitis or osteomyelitis
- No documented or suspected gram-positive pneumonia
- No suspected or proven endocarditis
PATIENT CHARACTERISTICS:
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Life expectancy ≥ 2 weeks
- Creatinine clearance ≥ 50 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective double-method contraception
- No known sensitivity to daptomycin or product excipients
- No history of or concurrent rhabdomyolysis
- No HIV positivity
- No psychiatric disorders that would preclude study compliance
- No signs or symptoms of myopathy with creatine phosphokinase (CPK) elevation > 1,000 U/L (5 times upper limit of normal [ULN])
- No CPK elevations > 10 times ULN in patients with no signs or symptoms of myopathy
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 7 days since prior daptomycin or other antibiotic agents covering gram-positive organisms
- No concurrent hemodialysis or continuous ambulatory peritoneal dialysis
- No concurrent succinylcholine, ethanol, fludrocortisone, olanzapine, or pioglitazone
- No concurrent hydroxymethyl glutaryl (HMG) coenzyme A (HMG CoA) reductase inhibitors (e.g., lovastatin, simvastatin, atorvastatin)
- Concurrent therapy for gram-negative bacterial infection allowed
Trial locations and contacts
1 site in 1 country.
United States1 site
OHSU Knight Cancer Institute
Portland, Oregon, 97239
About this study
Official title: Phase II Open Label Pilot Trial of Empiric Daptomycin Treatment for Oncology Patients With Neutropenic Fever
RATIONALE: Antibiotics, such as daptomycin, may control neutropenia, fever, and infection in patients with cancer.
PURPOSE: This phase II trial is studying how well daptomycin works in treating neutropenia and fever in patients with cancer.
Read the detailed description
OBJECTIVES:
Primary
- Assess the response rate to therapy within 72 hours of starting daptomycin in cancer patients with neutropenic fever.
Secondary
- Assess the percentage of bacterial cures in patients with documented gram-positive bacterial infections.
- Assess time to afebrile state.
- Assess the pharmacokinetic data of daptomycin in neutropenic patients.
- Document the incidence of breakthrough infections that require a change of therapy or additional agents to clear.
- Assess the tolerability of daptomycin in neutropenic patients.
- Assess and document adverse events and toxicity due to daptomycin.
OUTLINE: This is an open-label, pilot study.
Patients first receive standard treatment for gram-negative bacteria for 72 hours. If the patient is still febrile at 72 hours, daptomycin is administered.
Patients receive daptomycin IV over 30 minutes once daily. Patients who are afebrile, not neutropenic (absolute neutrophil count [ANC] > 500/mm³), and have no signs of infection after 72 hours of therapy may discontinue daptomycin. Patients who are afebrile and neutropenic (ANC < 500/mm³) after 72 hours of therapy continue to receive daptomycin until absolute neutrophil count (ANC) > 500/mm³ for 2 consecutive days. Patients who are febrile with or without continued neutropenia (ANC < 500/mm³) after 72 hours of therapy continue to receive daptomycin for up to 10-14 days in the absence of unacceptable toxicity.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
- Conditions
- Fever, Sweating, Hot Flashes, Infection, Neutropenia, Unspecified Adult Solid Tumor, Protocol Specific
- Being tested
- Daptomycin
- Keywords
- neutropenia, infection, unspecified adult solid tumor, protocol specific, fever, sweats, and hot flashes
- Medical subject headings
- Fever, Hot Flashes, Infections, Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DaptomycinDrug
Also called Cubicin
daptomycin 6 mg/kg over 30 minutes every 24 hours until patient is afebrile and ANC is >500 cells/mm^3.
| Study group | Role | What they receive |
|---|---|---|
| Daptomycin | Experimental | Not described Receives: Drug: Daptomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Became Afebrile Within 72 Hours of Starting Daptomycin.
If after 72 hours of daptomycin treatment, the patient is afebrile and has absolute neutrophil count (ANC) >500 cells/mm^3 for 48 hours with no site of infection, negative cultures, and no clinical indications for therapy, the antibiotic regimen will be discontinued.
Complete Response: Resolution of fever and clinical signs/symptoms of infection.
Partial Response: Resolution of fever without resolution of clinical signs of infection.
Measured: Within 72 hours of starting daptomycin
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2006 (estimated)
- Study startDec 2006
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for FeverStudies of the same condition, open and under way.
- More trials run by OHSU Knight Cancer InstituteThe 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 2
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph Bubalo, OHSU Knight Cancer Institute
- Investigators
- Joseph Bubalo, PharmD, Principal investigator, OHSU Knight Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00335478
- Sponsor's protocol ID
- CDR0000476568
- Other IDs
- OHSU-CPC-05052-L, OHSU-1321, CUBIST-OHSU-CPC-05052-L
- Status last verified
- May 2017
- First submitted
- 8 Jun 2006
- Last updated
- 9 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Open Label Pilot Trial of Empiric Daptomycin Treatment for Oncology Patients With Neutropenic Fever
- ClinicalTrials.gov ID
- NCT00335478
- Acronym / sponsor ID
- CDR0000476568
- Conditions
- Fever, Sweating, Hot Flashes, Infection, Neutropenia, Unspecified Adult Solid Tumor, Protocol Specific
- Keywords
- neutropenia, infection, unspecified adult solid tumor, protocol specific, fever, sweats, and hot flashes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Study start
- Dec 2006
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 12 Jun 2006 (estimated)
- Results
- Posted 9 Aug 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Antibiotics, such as daptomycin, may control neutropenia, fever, and infection in patients with cancer.
PURPOSE: This phase II trial is studying how well daptomycin works in treating neutropenia and fever in patients with cancer.
Detailed description
OBJECTIVES:
Primary
- Assess the response rate to therapy within 72 hours of starting daptomycin in cancer patients with neutropenic fever.
Secondary
- Assess the percentage of bacterial cures in patients with documented gram-positive bacterial infections.
- Assess time to afebrile state.
- Assess the pharmacokinetic data of daptomycin in neutropenic patients.
- Document the incidence of breakthrough infections that require a change of therapy or additional agents to clear.
- Assess the tolerability of daptomycin in neutropenic patients.
- Assess and document adverse events and toxicity due to daptomycin.
OUTLINE: This is an open-label, pilot study.
Patients first receive standard treatment for gram-negative bacteria for 72 hours. If the patient is still febrile at 72 hours, daptomycin is administered.
Patients receive daptomycin IV over 30 minutes once daily. Patients who are afebrile, not neutropenic (absolute neutrophil count [ANC] > 500/mm³), and have no signs of infection after 72 hours of therapy may discontinue daptomycin. Patients who are afebrile and neutropenic (ANC < 500/mm³) after 72 hours of therapy continue to receive daptomycin until absolute neutrophil count (ANC) > 500/mm³ for 2 consecutive days. Patients who are febrile with or without continued neutropenia (ANC < 500/mm³) after 72 hours of therapy continue to receive daptomycin for up to 10-14 days in the absence of unacceptable toxicity.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Daptomycin | Experimental | Drug: Daptomycin |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| DaptomycinAlso: Cubicindaptomycin 6 mg/kg over 30 minutes every 24 hours until patient is afebrile and ANC is >500 cells/mm^3. | Drug | Daptomycin |
Primary outcome
Number of Participants Who Became Afebrile Within 72 Hours of Starting Daptomycin.
Time frame: Within 72 hours of starting daptomycin
If after 72 hours of daptomycin treatment, the patient is afebrile and has absolute neutrophil count (ANC) >500 cells/mm^3 for 48 hours with no site of infection, negative cultures, and no clinical indications for therapy, the antibiotic regimen will be discontinued. Complete Response: Resolution of fever and clinical signs/symptoms of infection. Partial Response: Resolution of fever without resolution of clinical signs of infection.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Joseph Bubalo, PharmD principal investigator
OHSU Knight Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Daptomycin in people with Fever and Sweating, run by OHSU Knight Cancer Institute 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?
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 9 May 2017. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Aug 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Who Became Afebrile Within 72 Hours of Starting Daptomycin. (time frame: Within 72 hours of starting daptomycin). 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 9 May 2017.