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Comparative Study To Determine The Efficacy, Safety, And Tolerability Of Ceftolozane-Tazobactam

NCT03485950 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2022-03-15

Study results available
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Summary

The goal of this clinical research study is to learn if the study drug ceftolozane-tazobactam is more effective in controlling febrile neutropenia (fever and low white blood cell counts) than using approved antibiotics in patients with cancer. The safety of ceftolozane-tazobactam will also be studied.

This is an investigational study. Ceftolozane-tazobactam is FDA approved and commercially available to treat certain types of infections. It is not approved for the treatment of febrile neutropenia, either by itself or in combination with other antibiotics. Its use to treat febrile neutropenia is investigational.

All other antibiotics given on this study are FDA approved and commercially available for the treatment of infections. However, only cefepime is specifically FDA approved to treat febrile neutropenia. The study doctor can explain how the study drugs are designed to work.

Up to 100 participants will take part in this study. All will be enrolled at MD Anderson.

Conditions

  • Other Infectious Diseases

Interventions

DRUG

Cefepime

Given IV

DRUG

Ceftolozane

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Meropenem

Given IV

DRUG

Piperacillin-Tazobactam

Given IV

DRUG

Tazobactam

Given IV

Sponsors & Collaborators

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • National Cancer Institute (NCI)

    collaborator NIH

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Issam I Raad · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-16
Primary Completion
2021-05-01
Completion
2022-02-16
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03485950 on ClinicalTrials.gov