CEFtolozane-Tazobactam for the Empiric Anti-bacterial Treatment of Neutropenic Fever in Hematology Patients

• Status: Not yet recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Patients with blood cancers and those who received a bone marrow transplant frequently have low circulating white blood cell countS. Fever in patients with low white blood cell count requires early appropriate antibiotic treatment to prevent complications including death. Bacteria have increasingly become more resistant to existing antibiotic options. Ceftolozane-tazobactam is a newer type of antibiotic that has been shown to be safe and effective in infections caused by several types of resistant bacteria that can cause serious infections in individuals with low blood count. This study aims to examine the effectiveness of this antibiotic in these types of patients.

Patients with blood cancer and those who have received a bone transplant will be offered the option to join this study if they develop unexplained fever. If informed consent is granted, they will receive ceftolozane-tazobactam on top of the usual care that such patients receive. The patients will then be followed very closely to check their response to the treatment and if they develop any untoward events. The study will include 164 patients over an estimated 2 year period.

The study is funded by Merck & Co, the company that manufactures the study antibiotic. However, Merck & Co. will not be involved in the actual running of the study, the collection of the study results or their analysis and interpretation. The study protocol has been reviewed and approved by an independent research oversight committee.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hamad Medical Corporation
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Ceftolozane; Ceftolozane, tazobactam drug combination; Tazobactam

Criteria

Inclusion Criteria:

• Hospitalized with an underlying diagnosis of hematological cancer or receipt of hematopoietic stem cell transplantation.

• Age ≥18 years.

• Absolute neutrophil count (ANC) of <0.5x10^9/L or <1.0x10^9/L with a predicted decline to <0.5x10^9/L within the next 2 days.

• Oral temperature of ≥ 38.3 °C once, ≥ 38.0 °C lasting for at least 1 hour, or ≥ 38.0 °C twice within 12 hours.

Exclusion Criteria:

• Allergy to cephalosporins.

• Expected survival of ≤72 hours.

• Expected ANC recovery within ≤72 hours.

• Receipt of any antipseudomonal carbapenem therapy within the preceding 14 days.

• Documented current or past infection or colonization with ceftolozane-tazobactam- resistant Enterobacterales or P. aeruginosa.

• Pregnancy.

• Previous enrollment in CEF-10 Study (subjects previously enrolled in this study cannot be enrolled again during subsequent episodes of neutropenic fever).

• Ongoing therapy or planned continuation of therapy outside the National Center for Cancer Care and Research.