CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 100 enrolled
Drug / intervention
Imipenem/Cilastatin/Relebactam +6 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04983901
NCT04983901Phase 2Completed

An Investigator Initiated, Phase II Single-Center, Randomized, Open-Label, Prospective, Study To Determine The Impact Of Serial Procalcitonin On Improving Antimicrobial Stewardship And On The Efficacy, Safety, And Tolerability Of Imipenem-Cilastatin-Relebactam Plus/Minus Vancomycin Or Linezolid Versus Standard Of Care Antipseudomonal Beta-Lactams Plus/Minus Vancomycin Or Linezolid As Empiric Therapy In Febrile Neutropenic Adults With Cancer

M.D. Anderson Cancer Center·interventional·Posted Jul 30, 2021·Updated Apr 6, 2026

In Brief

A Phase 2 clinical trial evaluating Imipenem/Cilastatin/Relebactam, Cefepime, and 5 other interventions for Hematopoietic and Lymphoid Cell Neoplasm and Malignant Solid Neoplasm. Completed, enrolled 100 participants across 1 site.

Detailed Summary

This phase II trial studies the effect of imipenem-relebactam in treating patients with cancer who have a fever due to low white blood cell counts (febrile neutropenia). In this study, imipenem-relebactam will be compared to the standard-of-care treatment (cefepime, meropenem, or piperacillin/tazobactam) for the treatment of febrile neutropenia. Imipenem-relebactam is used to treat infections. Giving imipenem-relebactam may help to control febrile neutropenia in patients with cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
20222023202420252026
First PostedJul 30, 2021
Enrollment StartSep 14, 2021
Primary CompletionOct 6, 2023
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 4.9 years ago

Interventions

Imipenem/Cilastatin/Relebactamdrug

Given IV

Cefepimedrug

Given IV

Meropenemdrug

Given IV

Piperacillin-Tazobactamdrug

Given IV

Vancomycindrug

Given IV

Daptomycindrug

Given IV

Linezoliddrug

Given IV or PO