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

Weill Cornell Medicine (WCM)

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Hematologic Malignancy; Pneumonia; Pseudomonas Aeruginosa

Treatments: Drug: Ceftolozane / Tazobactam Injection

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04673175

19-11021048

Details and patient eligibility

About

This is an open-label study, where participants will be given ceftolozane-tazobactam as the primary treatment for Pseudomonas aeruginosa infections. Open-label means both the investigator and the participant will known what drug will be given. Participants will be followed for approximately 60 days. Ceftolozane-tazobactam is approved by the Food and Drug Administration (FDA) for treatment of serious bacterial infection and the investigator hypothesizes that ceftolozane/tazobactam may be effective as the primary antibiotic treatment for Pseudomonas aeruginosa infections.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• At least 18 years old
• Presence of hematologic malignancy or Hematopoietic Stem Cell Transplantation
• Identification of Pseudomonas aeruginosa by rapid molecular diagnostic assay from a blood culture or from a respiratory sample in the setting of radiologically documented pneumonia and clinical symptoms compatible with pneumonia.

Exclusion criteria

• Anaphylactic hypersensitivity or allergic reaction to cephalosporins
• Participants with expected mortality within 48 hours
• Hemodialysis or continuous renal replacement therapy, or creatinine clearance <15 ml/min
• Prior non-study anti-pseudomonal therapy for >72 hours
• History of a strain of Pseudomonas aeruginosa with MIC >4 microgram/ml to ceftolozane/tazobactam
• Polymicrobial aerobic Gram-negative infection as determined by ID research team

Patients who completed this study and subsequently experience a separate, recurrent Pseudomonas aeruginosa infection, may be re-enrolled into this study if all eligibility criteria are met.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Ceftolozane-Tazobactam

Experimental group

Description:

Participants receive ceftolozane-tazobactam by injection directly into the vein (intravenously, IV) every 8 hours for 10-14 days.

Treatment:

Drug: Ceftolozane / Tazobactam Injection