NeoplasmsPhase 2NCT02732327
Comparative Study of Ceftazidime-Avibactam Versus Standard of Care as Therapy in Febrile Neutropenic Adults With Cancer
A Phase 2 study testing CAZ-AVI, Vancomycin and Linezolid in people with Neoplasms and Febrile Neutropenia, run by Forest Laboratories at 1 site in United States.
Trial summary
This study will evaluate the effect, safety, and tolerability of ceftazidime-avibactam (CAZ-AVI) plus vancomycin or linezolid compared to standard of care plus vancomycin or linezolid as empiric therapy in febrile neutropenic adults with cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms, Febrile Neutropenia
- What is being tested?
- CAZ-AVI, Vancomycin and Linezolid
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 17 May 2016to 27 Jun 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with neutropenic fever who have existing malignancy or have undergone hematopoietic stem cell transplantation
- Requires hospitalization for intravenous (IV) empiric antibiotic therapy
Who cannot join
- Fungal or viral infection requiring additional therapy
- Known acute viral hepatitis
- Known to be human immunodeficiency virus (HIV) positive
- Expected requirement for hemodialysis while on study therapy
- Received >24 hours of systemic antibacterial therapy within 72 hours of initiation of inpatient IV study drug
- Past or current history of epilepsy or seizure disorder
- Evidence of immediately life-threatening disease, progressively fatal disease, or life expectancy of 3 months or less.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Center, Randomized, Open-label, Prospective, Comparative Study to Determine the Efficacy, Safety, and Tolerability of Ceftazidime-Avibactam (CAZ-AVI) Plus Vancomycin or Linezolid Versus Standard of Care Plus Vancomycin or Linezolid as Empiric Therapy in Febrile Neutropenic Adults With Cancer
This study will evaluate the effect, safety, and tolerability of ceftazidime-avibactam (CAZ-AVI) plus vancomycin or linezolid compared to standard of care plus vancomycin or linezolid as empiric therapy in febrile neutropenic adults with cancer
- Conditions
- Neoplasms, Febrile Neutropenia
- Being tested
- CAZ-AVI, Vancomycin, Linezolid, Cefepime, Meropenem
- Medical subject headings
- Neoplasms, Febrile Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAZ-AVIDrug
Ceftazidime-Avibactam (2 g ceftazidime and 0.5 g avibactam)
VancomycinDrug
Also called Vancocin
15 mg/kg
LinezolidDrug
Also called Zyvox
600 mg
CefepimeDrug
Also called Maxipime
2 g
MeropenemDrug
Also called Merrem
1 g
Piperacillin/tazobactamDrug
Also called Zosyn
4.5 g
| Study group | Role | What they receive |
|---|---|---|
| CAZ-AVI + Vancomycin or Linezolid | Experimental | Ceftazidime-Avibactam (CAZ-AVI) 2.5 mg intravenous (IV) infusion every 8 hours for 5 to 14 days, duration determined by the investigator, plus vancomycin 15 mg/kg IV or linezolid 600 mg IV every 12 hours. A switch to open-label oral or IV therapy (IV therapy for outpatient or home administration per local standard of care [SOC]) may be allowed after at least 72 hours (ie, minimum of 9 doses for CAZ-AVI) of inpatient IV study drug. Receives: Drug: CAZ-AVI; Drug: Vancomycin; Drug: Linezolid |
| Standard of Care+Vancomycin or Linezolid | Active comparator | Standard of Care (cefepime 2 g IV infusion every 8 hours or meropenem 1 g IV infusion every 8 hours or piperacillin/tazobactam 4.5 g IV infusion every 6 hours for 5 to 14 days, duration determined by the investigator) plus vancomycin 15 mg/kg IV or linezolid 600 mg IV every 12 hours. A switch to open-label oral or IV therapy (IV therapy for outpatient or home administration per local SOC) may be allowed after at least 72 hours (ie, minimum of 9 doses for SOC therapies, except piperacillin/tazobactam, which is a minimum of 12 doses) of inpatient IV study drug. Receives: Drug: Vancomycin; Drug: Linezolid; Drug: Cefepime; Drug: Meropenem; Drug: Piperacillin/tazobactam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients With Favorable Clinical Response at End of Inpatient Intravenous Therapy (EOIV)
Favorable clinical response is defined as resolution of all acute signs and symptoms of the primary infection or improvement to such an extent that no additional antibacterial therapy is required as assessed by the investigator. Due to study termination and limited enrollment, outcome measures were not analyzed.
Measured: Up to Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2016 (estimated)
- Study start17 May 2016
- Primary completion27 Jun 2016
- Study completion27 Jun 2016
Why it stopped: No longer aligned with the revised clinical development plan and commercial strategy
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 NeoplasmsStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Forest Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Melnick, M.D., Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02732327
- Sponsor's protocol ID
- CAZ-MD-13
- Status last verified
- Jun 2017
- First submitted
- 18 Mar 2016
- Last updated
- 21 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Randomized, Open-label, Prospective, Comparative Study to Determine the Efficacy, Safety, and Tolerability of Ceftazidime-Avibactam (CAZ-AVI) Plus Vancomycin or Linezolid Versus Standard of Care Plus Vancomycin or Linezolid as Empiric Therapy in Febrile Neutropenic Adults With Cancer
- ClinicalTrials.gov ID
- NCT02732327
- Acronym / sponsor ID
- CAZ-MD-13
- Conditions
- Neoplasms, Febrile Neutropenia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No longer aligned with the revised clinical development plan and commercial strategy
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Forest LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- 17 May 2016 (actual)
- Primary completion
- 27 Jun 2016 (actual)
- Study completion
- 27 Jun 2016 (actual)
- First posted
- 8 Apr 2016 (estimated)
- Results
- Posted 21 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the effect, safety, and tolerability of ceftazidime-avibactam (CAZ-AVI) plus vancomycin or linezolid compared to standard of care plus vancomycin or linezolid as empiric therapy in febrile neutropenic adults with cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAZ-AVI + Vancomycin or Linezolid | Experimental | Drug: CAZ-AVI, Drug: Vancomycin, Drug: LinezolidCeftazidime-Avibactam (CAZ-AVI) 2.5 mg intravenous (IV) infusion every 8 hours for 5 to 14 days, duration determined by the investigator, plus vancomycin 15 mg/kg IV or linezolid 600 mg IV every 12 hours. A switch to open-label oral or IV therapy (IV therapy for outpatient or home administration per local standard of care [SOC]) may be allowed after at least 72 hours (ie, minimum of 9 doses for CAZ-AVI) of inpatient IV study drug. |
| Standard of Care+Vancomycin or Linezolid | Active comparator | Drug: Vancomycin, Drug: Linezolid, Drug: Cefepime, Drug: Meropenem, Drug: Piperacillin/tazobactamStandard of Care (cefepime 2 g IV infusion every 8 hours or meropenem 1 g IV infusion every 8 hours or piperacillin/tazobactam 4.5 g IV infusion every 6 hours for 5 to 14 days, duration determined by the investigator) plus vancomycin 15 mg/kg IV or linezolid 600 mg IV every 12 hours. A switch to open-label oral or IV therapy (IV therapy for outpatient or home administration per local SOC) may be allowed after at least 72 hours (ie, minimum of 9 doses for SOC therapies, except piperacillin/tazobactam, which is a minimum of 12 doses) of inpatient IV study drug. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with neutropenic fever who have existing malignancy or have undergone hematopoietic stem cell transplantation
- Requires hospitalization for intravenous (IV) empiric antibiotic therapy
Key exclusion criteria (7 listed)
- Fungal or viral infection requiring additional therapy
- Known acute viral hepatitis
- Known to be human immunodeficiency virus (HIV) positive
- Expected requirement for hemodialysis while on study therapy
- Received >24 hours of systemic antibacterial therapy within 72 hours of initiation of inpatient IV study drug
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 |
|---|---|---|
| CAZ-AVICeftazidime-Avibactam (2 g ceftazidime and 0.5 g avibactam) | Drug | CAZ-AVI + Vancomycin or Linezolid |
| VancomycinAlso: Vancocin15 mg/kg | Drug | CAZ-AVI + Vancomycin or Linezolid, Standard of Care+Vancomycin or Linezolid |
| LinezolidAlso: Zyvox600 mg | Drug | CAZ-AVI + Vancomycin or Linezolid, Standard of Care+Vancomycin or Linezolid |
| CefepimeAlso: Maxipime2 g | Drug | Standard of Care+Vancomycin or Linezolid |
| MeropenemAlso: Merrem1 g | Drug | Standard of Care+Vancomycin or Linezolid |
| Piperacillin/tazobactamAlso: Zosyn4.5 g | Drug | Standard of Care+Vancomycin or Linezolid |
Primary outcome
Percentage of Patients With Favorable Clinical Response at End of Inpatient Intravenous Therapy (EOIV)
Time frame: Up to Day 14
Favorable clinical response is defined as resolution of all acute signs and symptoms of the primary infection or improvement to such an extent that no additional antibacterial therapy is required as assessed by the investigator. Due to study termination and limited enrollment, outcome measures were not analyzed.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
David Melnick, M.D. study director
Allergan
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 CAZ-AVI, Vancomycin and Linezolid in people with Neoplasms and Febrile Neutropenia, run by Forest Laboratories 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 2 inclusion and 7 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: stopped early, as of the sponsor's last update on 21 Jul 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 21 Jul 2017). 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?
Percentage of Patients With Favorable Clinical Response at End of Inpatient Intravenous Therapy (EOIV) (time frame: Up to Day 14). 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 21 Jul 2017.