Ceftolozane-Tazobactam for Directed Treatment of Pseudomonas Aeruginosa Bacteremia and Pneumonia in Patients With Hematological Malignancies and Hematopoietic Stem Cell Transplantation

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-10

Study Completion Date

2025-03-16

Brief Summary

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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.

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Detailed Description

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Conditions

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Pneumonia Hematologic Malignancy Pseudomonas Aeruginosa Infection Bacteremia Hematopoietic Stem Cell Transplant (HSCT)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

This is an open-label study. No parties are masked.

Study Groups

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Ceftolozane-Tazobactam (Prospective Treatment Arm)

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.

Group Type EXPERIMENTAL

Ceftolozane / Tazobactam Injection

Intervention Type DRUG

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).

Historical Control (Standard of Care Prior to Study)

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Ceftolozane / Tazobactam Injection

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).

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No