PneumoniaPhase 4NCT04673175
Ceftolozane-Tazobactam for Directed Treatment of Pseudomonas Aeruginosa Bacteremia and Pneumonia in Patients With Hematological Malignancies and Hematopoietic Stem Cell Transplantation
A Phase 4 study testing Ceftolozane / Tazobactam Injection in people with Pneumonia and Hematologic Malignancy, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn whether the antibiotic ceftolozane-tazobactam works to treat serious Pseudomonas aeruginosa infections in people with blood cancers or who received a stem cell transplant. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia, Hematologic Malignancy, Pseudomonas Aeruginosa Infection
- What is being tested?
- Ceftolozane / Tazobactam Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2023to 16 Mar 2025
- Phase
- Phase 4
- 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
- Presence of a hematologic malignancy or a history of hematopoietic stem cell transplantation
- Identification of Pseudomonas aeruginosa by rapid molecular diagnostic testing from a positive blood culture or from a respiratory sample in the setting of radiologically documented pneumonia with compatible clinical symptoms
- Age 18 years or older
- Ability of the participant or legally authorized representative to provide informed consent
- Presence of a hematologic malignancy or a history of hematopoietic stem cell transplantation
- Identification of Pseudomonas aeruginosa associated with bacteremia and or pneumonia
- Age 18 years or older
- Survival greater than 48 hours after initiation of anti pseudomonal therapy for Pseudomonas aeruginosa bacteremia and or pneumonia
Who cannot join
- Receipt of more than 72 hours of non-study anti pseudomonal therapy for the infection being treated
- Known anaphylactic hypersensitivity or allergic reaction to cephalosporins
- History of a Pseudomonas aeruginosa isolate with a ceftolozane or tazobactam MIC greater than 4 micrograms per milliliter
- Polymicrobial aerobic Gram negative infection, as determined by the infectious diseases research team
- Hemodialysis, continuous renal replacement therapy, or creatinine clearance less than 15 milliliters per minute
- Expected mortality within 48 hours of screening
Show all 11Show fewer
- Eligibility Criteria for Historical Controls
- Known anaphylactic hypersensitivity or allergic reaction to cephalosporins
- History of a Pseudomonas aeruginosa isolate with a ceftolozane or tazobactam MIC greater than 4 micrograms per milliliter
- Polymicrobial aerobic Gram negative infection, as determined by the infectious diseases research team
- Hemodialysis, continuous renal replacement therapy, or creatinine clearance less than 15 milliliters per minute
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study of Ceftolozane-Tazobactam in Conjunction With Rapid Molecular Diagnosis for Directed Treatment of Pseudomonas Aeruginosa Bacteremia and Pneumonia in Patients With Hematological Malignancies and Hematopoietic Stem Cell Transplantation
The goal of this clinical trial is to learn whether the antibiotic ceftolozane-tazobactam works to treat serious Pseudomonas aeruginosa infections in people with blood cancers or who received a stem cell transplant. The main question it aims to answer is whether participants reach clinical success 30 days after the infection is first found. Clinical success means the person is alive, their infection symptoms are improving, and the infection has not returned.
Participants will receive ceftolozane-tazobactam through a vein every 8 hours for 10 to 14 days. Treatment may continue for up to 21 days if the infection is not improving or keeps coming back. The infection is diagnosed using the hospital's standard rapid molecular tests, which help confirm Pseudomonas aeruginosa quickly so treatment can begin right away.
Read more
Researchers will follow participants during their hospital stay and check on them around 30 and 60 days to see how well the treatment worked. The study will also look at how long it takes for the infection to clear, how long participants stay in the hospital or intensive care unit, and whether the bacteria become resistant to antibiotics.
In addition to the prospective ceftolozane-tazobactam group, the study includes a historical control group made up of patients with similar infections who were treated in the past with standard anti-pseudomonal antibiotics (such as cefepime, ceftazidime, piperacillin-tazobactam, or meropenem). Data from these historical controls are collected by chart review and analyzed alongside the prospective group to compare outcomes. Historical controls do not receive study-directed treatment and are not actively enrolled under this protocol.
- Conditions
- Pneumonia, Hematologic Malignancy, Pseudomonas Aeruginosa Infection, Bacteremia, Hematopoietic Stem Cell Transplant (HSCT)
- Being tested
- Ceftolozane / Tazobactam Injection
- Keywords
- Pseudomonas Aeruginosa, Pneumonia, Hematologic Malignancy, Ceftolozane-Tazobactam, Zerbaxa, Stem Cell Transplant Recipients, Immunocompromised Hosts, Gram-Negative Bacterial Infections
- Medical subject headings
- Pneumonia, Hematologic Neoplasms, Pseudomonas Infections, Bacteremia, Gram-Negative Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ceftolozane / Tazobactam InjectionDrug
Zerbaxa (ceftolozane/tazobactam) for injection is supplied as a white to yellow sterile powder for reconstitution in single-use vials; each vial contains 1 g ceftolozane (equivalent to 1.147 g of ceftolozane sulfate) and 0.5 g tazobactam (equivalent to 0.537 g of tazobactam sodium).
| Study group | Role | What they receive |
|---|---|---|
| Ceftolozane-Tazobactam (Prospective Treatment Arm) | Experimental | Participants prospectively enrolled in the study received ceftolozane-tazobactam intravenously every 8 hours for approximately 10 to 14 days, with treatment extended up to 21 days if infection persisted or recurred. Outcomes for this arm were assessed according to the protocol's primary and secondary endpoints. Receives: Drug: Ceftolozane / Tazobactam Injection |
| Historical Control (Standard of Care Prior to Study) | No intervention | This arm consists of historical control patients with documented Pseudomonas aeruginosa bacteremia and/or pneumonia who received standard-of-care antimicrobial therapy prior to initiation of this study. These patients were included retrospectively for comparative analyses of selected primary and secondary endpoints. No study interventions were administered to this arm. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Success at Day 30
Clinical success 30 days after collection of the index culture. Clinical success is defined as meeting all of the following criteria at that time point: survival; resolution or near resolution of baseline clinical manifestations, including fever, hypoxia, and signs or symptoms of sepsis; and absence of recurrent infection due to Pseudomonas aeruginosa or persistent infection despite more than 7 days of anti-pseudomonal therapy.
Measured: 30 days after collection of the index culture
Secondary outcomes (11)
Survival at Day 30
Survival status 30 days after initiation of anti-pseudomonal therapy for the index infection, assessed by chart review or phone contact.
Measured: 30 days after initiation of anti-pseudomonal therapy for the index infection
Survival at Day 60
Survival status 60 days after initiation of anti-pseudomonal therapy for the index infection, assessed by chart review or phone contact.
Measured: 60 days after initiation of anti-pseudomonal therapy for the index infection
Time to Resolution of Bacteremia
Time (days) from the index positive blood culture for Pseudomonas aeruginosa to bacteremia resolution. Resolution was defined as the date of the first of two consecutive negative blood cultures obtained after the index culture. Participants without follow-up blood cultures were excluded from this analysis.
Measured: From index culture collection up to 60 days
Length of Hospital Stay
Total number of days hospitalized for the admission during which the index Pseudomonas aeruginosa infection is treated, measured beginning on the date of index culture collection and obtained from the Hospitalization Status Assessment.
Measured: From index culture collection through discharge from the hospital admission for the index infection (up to 60 days)
Emergence of Ceftolozane-tazobactam Resistant Isolates
Occurrence of Pseudomonas aeruginosa isolates that newly demonstrate resistance to ceftolozane-tazobactam on antimicrobial susceptibility testing after initiation of therapy for the index infection.
Measured: From index culture collection up to 60 days
Time to Appropriate Therapy
Time (in hours) from index culture collection for the index Pseudomonas aeruginosa infection to initiation of an anti-pseudomonal agent deemed appropriate based on antimicrobial susceptibility results.
Measured: From index culture collection up to 60 days
Resolution of Baseline Clinical Manifestations
Resolution or near resolution of baseline fever, hypoxia, or signs and symptoms of sepsis related to the index infection at 30 days after index culture collection, as assessed by physical examination findings and clinical documentation.
Measured: 30 days after collection of the index culture
Modifications to Initial Antimicrobial Therapy
Number of participants with any modification to the initial study-directed anti-pseudomonal regimen for the index infection, defined as either (1) discontinuation of ceftolozane-tazobactam with switch to another anti-pseudomonal agent or (2) addition of another anti-pseudomonal antibiotic during the treatment course. Outpatient levofloxacin was not considered a modification.
Measured: From initiation of study ceftolozane-tazobactam therapy through end of study-directed anti-pseudomonal treatment (up to 21 days)
Emergence of Other Bacteria During Therapy
Identification of new bacterial pathogens identified in blood cultures during study-directed ceftolozane-tazobactam treatment for the index infection.
Measured: From initiation of study ceftolozane-tazobactam therapy through end of ceftolozane-tazobactam treatment (up to 21 days)
Number of Days on Ventilator
Total number of days requiring invasive mechanical ventilation during the index admission, measured beginning on the date of index culture collection and abstracted from the medical record.
Measured: From index culture collection through discharge from the hospital admission for the index infection (up to 60 days)
ICU Length of Stay
Total number of days spent in an intensive care unit during the index admission, measured beginning on the date of index culture collection and obtained from the Hospitalization Status Assessment.
Measured: From index culture collection through discharge from the hospital admission for the index infection (up to 60 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start10 Jan 2023
- Primary completion16 Mar 2025
- Study completion16 Mar 2025
Why it stopped: Due to slow accrual.
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.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The study includes two groups analyzed in parallel: (1) a prospective treatment arm in which participants receive ceftolozane-tazobactam for Pseudomonas aeruginosa infection, and (2) a historical control arm consisting of patients previously treated with standard-of-care anti-pseudomonal therapy. Historical controls are identified retrospectively and are not prospectively assigned or treated under this protocol.
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Markus Plate, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04673175
- Sponsor's protocol ID
- 19-11021048
- Status last verified
- Jan 2026
- First submitted
- 4 Dec 2020
- Last updated
- 21 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Satlin MJ, Walsh TJ. Multidrug-resistant Enterobacteriaceae, Pseudomonas aeruginosa, and vancomycin-resistant Enterococcus: Three major threats to hematopoietic stem cell transplant recipients. Transpl Infect Dis. 2017 Dec;19(6):10.1111/tid.12762. doi: 10.1111/tid.12762. Epub 2017 Oct 25.
PubMed 28815897Freifeld AG, Bow EJ, Sepkowitz KA, Boeckh MJ, Ito JI, Mullen CA, Raad II, Rolston KV, Young JA, Wingard JR; Infectious Diseases Society of America. Clinical practice guideline for the use of antimicrobial agents in neutropenic patients with cancer: 2010 update by the infectious diseases society of america. Clin Infect Dis. 2011 Feb 15;52(4):e56-93. doi: 10.1093/cid/cir073.
PubMed 21258094Nguyen L, Garcia J, Gruenberg K, MacDougall C. Multidrug-Resistant Pseudomonas Infections: Hard to Treat, But Hope on the Horizon? Curr Infect Dis Rep. 2018 Jun 6;20(8):23. doi: 10.1007/s11908-018-0629-6.
PubMed 29876674Kaye KS, Pogue JM. Infections Caused by Resistant Gram-Negative Bacteria: Epidemiology and Management. Pharmacotherapy. 2015 Oct;35(10):949-62. doi: 10.1002/phar.1636.
PubMed 26497481Munita JM, Aitken SL, Miller WR, Perez F, Rosa R, Shimose LA, Lichtenberger PN, Abbo LM, Jain R, Nigo M, Wanger A, Araos R, Tran TT, Adachi J, Rakita R, Shelburne S, Bonomo RA, Arias CA. Multicenter Evaluation of Ceftolozane/Tazobactam for Serious Infections Caused by Carbapenem-Resistant Pseudomonas aeruginosa. Clin Infect Dis. 2017 Jul 1;65(1):158-161. doi: 10.1093/cid/cix014.
PubMed 28329350Gallagher JC, Satlin MJ, Elabor A, Saraiya N, McCreary EK, Molnar E, El-Beyrouty C, Jones BM, Dixit D, Heil EL, Claeys KC, Hiles J, Vyas NM, Bland CM, Suh J, Biason K, McCoy D, King MA, Richards L, Harrington N, Guo Y, Chaudhry S, Lu X, Yu D. Ceftolozane-Tazobactam for the Treatment of Multidrug-Resistant Pseudomonas aeruginosa Infections: A Multicenter Study. Open Forum Infect Dis. 2018 Oct 31;5(11):ofy280. doi: 10.1093/ofid/ofy280. eCollection 2018 Nov.
PubMed 30488041Petraitis V, Petraitiene R, Naing E, Aung T, Thi WP, Kavaliauskas P, Win Maung BB, Michel AO, Ricart Arbona RJ, DeRyke AC, Culshaw DL, Nicolau DP, Satlin MJ, Walsh TJ. Ceftolozane-Tazobactam in the Treatment of Experimental Pseudomonas aeruginosa Pneumonia in Persistently Neutropenic Rabbits: Impact on Strains with Genetically Defined Mechanisms of Resistance. Antimicrob Agents Chemother. 2019 Aug 23;63(9):e00344-19. doi: 10.1128/AAC.00344-19. Print 2019 Sep.
PubMed 31235620
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Ceftolozane-Tazobactam in Conjunction With Rapid Molecular Diagnosis for Directed Treatment of Pseudomonas Aeruginosa Bacteremia and Pneumonia in Patients With Hematological Malignancies and Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT04673175
- Acronym / sponsor ID
- 19-11021048
- Conditions
- Pneumonia, Hematologic Malignancy, Pseudomonas Aeruginosa Infection, Bacteremia, Hematopoietic Stem Cell Transplant (HSCT)
- Keywords
- Pseudomonas Aeruginosa, Pneumonia, Hematologic Malignancy, Ceftolozane-Tazobactam, Zerbaxa, Stem Cell Transplant Recipients, Immunocompromised Hosts, Gram-Negative Bacterial Infections
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to slow accrual.
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- 16 Mar 2025 (actual)
- Study completion
- 16 Mar 2025 (actual)
- First posted
- 17 Dec 2020 (actual)
- Results
- Posted 21 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn whether the antibiotic ceftolozane-tazobactam works to treat serious Pseudomonas aeruginosa infections in people with blood cancers or who received a stem cell transplant. The main question it aims to answer is whether participants reach clinical success 30 days after the infection is first found. Clinical success means the person is alive, their infection symptoms are improving, and the infection has not returned.
Participants will receive ceftolozane-tazobactam through a vein every 8 hours for 10 to 14 days. Treatment may continue for up to 21 days if the infection is not improving or keeps coming back. The infection is diagnosed using the hospital's standard rapid molecular tests, which help confirm Pseudomonas aeruginosa quickly so treatment can begin right away.
Researchers will follow participants during their hospital stay and check on them around 30 and 60 days to see how well the treatment worked. The study will also look at how long it takes for the infection to clear, how long participants stay in the hospital or intensive care unit, and whether the bacteria become resistant to antibiotics.
In addition to the prospective ceftolozane-tazobactam group, the study includes a historical control group made up of patients with similar infections who were treated in the past with standard anti-pseudomonal antibiotics (such as cefepime, ceftazidime, piperacillin-tazobactam, or meropenem). Data from these historical controls are collected by chart review and analyzed alongside the prospective group to compare outcomes. Historical controls do not receive study-directed treatment and are not actively enrolled under this protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study includes two groups analyzed in parallel: (1) a prospective treatment arm in which participants receive ceftolozane-tazobactam for Pseudomonas aeruginosa infection, and (2) a historical control arm consisting of patients previously treated with standard-of-care anti-pseudomonal therapy. Historical controls are identified retrospectively and are not prospectively assigned or treated under this protocol.
| Arm | Type | Receives |
|---|---|---|
| Ceftolozane-Tazobactam (Prospective Treatment Arm) | Experimental | Drug: Ceftolozane / Tazobactam InjectionParticipants prospectively enrolled in the study received ceftolozane-tazobactam intravenously every 8 hours for approximately 10 to 14 days, with treatment extended up to 21 days if infection persisted or recurred. Outcomes for this arm were assessed according to the protocol's primary and secondary endpoints. |
| Historical Control (Standard of Care Prior to Study) | No intervention | –This arm consists of historical control patients with documented Pseudomonas aeruginosa bacteremia and/or pneumonia who received standard-of-care antimicrobial therapy prior to initiation of this study. These patients were included retrospectively for comparative analyses of selected primary and secondary endpoints. No study interventions were administered to this arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Presence of a hematologic malignancy or a history of hematopoietic stem cell transplantation
- Identification of Pseudomonas aeruginosa by rapid molecular diagnostic testing from a positive blood culture or from a respiratory sample in the setting of radiologically documented pneumonia with compatible clinical symptoms
- Age 18 years or older
- Ability of the participant or legally authorized representative to provide informed consent
- Presence of a hematologic malignancy or a history of hematopoietic stem cell transplantation
Key exclusion criteria (11 listed)
- Receipt of more than 72 hours of non-study anti pseudomonal therapy for the infection being treated
- Known anaphylactic hypersensitivity or allergic reaction to cephalosporins
- History of a Pseudomonas aeruginosa isolate with a ceftolozane or tazobactam MIC greater than 4 micrograms per milliliter
- Polymicrobial aerobic Gram negative infection, as determined by the infectious diseases research team
- Hemodialysis, continuous renal replacement therapy, or creatinine clearance less than 15 milliliters per minute
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 |
|---|---|---|
| Ceftolozane / Tazobactam InjectionZerbaxa (ceftolozane/tazobactam) for injection is supplied as a white to yellow sterile powder for reconstitution in single-use vials; each vial contains 1 g ceftolozane (equivalent to 1.147 g of ceftolozane sulfate) and 0.5 g tazobactam (equivalent to 0.537 g of tazobactam sodium). | Drug | Ceftolozane-Tazobactam (Prospective Treatment Arm) |
Primary outcome
Clinical Success at Day 30
Time frame: 30 days after collection of the index culture
Clinical success 30 days after collection of the index culture. Clinical success is defined as meeting all of the following criteria at that time point: survival; resolution or near resolution of baseline clinical manifestations, including fever, hypoxia, and signs or symptoms of sepsis; and absence of recurrent infection due to Pseudomonas aeruginosa or persistent infection despite more than 7 days of anti-pseudomonal therapy.
11 secondary outcomes
Survival at Day 30
Time frame: 30 days after initiation of anti-pseudomonal therapy for the index infection
Survival at Day 60
Time frame: 60 days after initiation of anti-pseudomonal therapy for the index infection
Time to Resolution of Bacteremia
Time frame: From index culture collection up to 60 days
Length of Hospital Stay
Time frame: From index culture collection through discharge from the hospital admission for the index infection (up to 60 days)
Emergence of Ceftolozane-tazobactam Resistant Isolates
Time frame: From index culture collection up to 60 days
Time to Appropriate Therapy
Time frame: From index culture collection up to 60 days
Resolution of Baseline Clinical Manifestations
Time frame: 30 days after collection of the index culture
Modifications to Initial Antimicrobial Therapy
Time frame: From initiation of study ceftolozane-tazobactam therapy through end of study-directed anti-pseudomonal treatment (up to 21 days)
Emergence of Other Bacteria During Therapy
Time frame: From initiation of study ceftolozane-tazobactam therapy through end of ceftolozane-tazobactam treatment (up to 21 days)
Number of Days on Ventilator
Time frame: From index culture collection through discharge from the hospital admission for the index infection (up to 60 days)
ICU Length of Stay
Time frame: From index culture collection through discharge from the hospital admission for the index infection (up to 60 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28815897Satlin MJ, Walsh TJ. Multidrug-resistant Enterobacteriaceae, Pseudomonas aeruginosa, and vancomycin-resistant Enterococcus: Three major threats to hematopoietic stem cell transplant recipients. Transpl Infect Dis. 2017 Dec;19(6):10.1111/tid.12762. doi: 10.1111/tid.12762. Epub 2017 Oct 25.
- Background: PubMed 21258094Freifeld AG, Bow EJ, Sepkowitz KA, Boeckh MJ, Ito JI, Mullen CA, Raad II, Rolston KV, Young JA, Wingard JR; Infectious Diseases Society of America. Clinical practice guideline for the use of antimicrobial agents in neutropenic patients with cancer: 2010 update by the infectious diseases society of america. Clin Infect Dis. 2011 Feb 15;52(4):e56-93. doi: 10.1093/cid/cir073.
- Background: PubMed 29876674Nguyen L, Garcia J, Gruenberg K, MacDougall C. Multidrug-Resistant Pseudomonas Infections: Hard to Treat, But Hope on the Horizon? Curr Infect Dis Rep. 2018 Jun 6;20(8):23. doi: 10.1007/s11908-018-0629-6.
- Background: PubMed 26497481Kaye KS, Pogue JM. Infections Caused by Resistant Gram-Negative Bacteria: Epidemiology and Management. Pharmacotherapy. 2015 Oct;35(10):949-62. doi: 10.1002/phar.1636.
- Background: PubMed 28329350Munita JM, Aitken SL, Miller WR, Perez F, Rosa R, Shimose LA, Lichtenberger PN, Abbo LM, Jain R, Nigo M, Wanger A, Araos R, Tran TT, Adachi J, Rakita R, Shelburne S, Bonomo RA, Arias CA. Multicenter Evaluation of Ceftolozane/Tazobactam for Serious Infections Caused by Carbapenem-Resistant Pseudomonas aeruginosa. Clin Infect Dis. 2017 Jul 1;65(1):158-161. doi: 10.1093/cid/cix014.
- Background: PubMed 30488041Gallagher JC, Satlin MJ, Elabor A, Saraiya N, McCreary EK, Molnar E, El-Beyrouty C, Jones BM, Dixit D, Heil EL, Claeys KC, Hiles J, Vyas NM, Bland CM, Suh J, Biason K, McCoy D, King MA, Richards L, Harrington N, Guo Y, Chaudhry S, Lu X, Yu D. Ceftolozane-Tazobactam for the Treatment of Multidrug-Resistant Pseudomonas aeruginosa Infections: A Multicenter Study. Open Forum Infect Dis. 2018 Oct 31;5(11):ofy280. doi: 10.1093/ofid/ofy280. eCollection 2018 Nov.
- Background: PubMed 31235620Petraitis V, Petraitiene R, Naing E, Aung T, Thi WP, Kavaliauskas P, Win Maung BB, Michel AO, Ricart Arbona RJ, DeRyke AC, Culshaw DL, Nicolau DP, Satlin MJ, Walsh TJ. Ceftolozane-Tazobactam in the Treatment of Experimental Pseudomonas aeruginosa Pneumonia in Persistently Neutropenic Rabbits: Impact on Strains with Genetically Defined Mechanisms of Resistance. Antimicrob Agents Chemother. 2019 Aug 23;63(9):e00344-19. doi: 10.1128/AAC.00344-19. Print 2019 Sep.
- 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.
Markus Plate, MD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ceftolozane / Tazobactam Injection in people with Pneumonia and Hematologic Malignancy, run by Weill Medical College of Cornell University 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 8 inclusion and 11 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 Jan 2026. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Jan 2026). 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?
Clinical Success at Day 30 (time frame: 30 days after collection of the index culture). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04673175, which also lists 7 linked publications.
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 Jan 2026; AzTrials last refreshed its copy on 8 Nov 2026.