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
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