← Back to Search

Carbapenem

Antimicrobial Therapy for Febrile Neutropenia

Phase 4
Recruiting
Led By John Williamson, PharmD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up hour 72
Awards & highlights

Summary

This trial looks at how to best treat fevers in cancer patients on chemo, when antibiotics aren't working.

Who is the study for?
Adults with blood cancers undergoing chemotherapy who have febrile neutropenia despite taking cefepime or piperacillin-tazobactam and posaconazole prophylaxis. They must have had a persistent or recurrent fever for at least 96 hours. Excluded are those with confirmed infections, known resistance to study drugs, allergies to the drugs being tested, valproic acid users, pregnant individuals, previous study participants, and those with uncontrolled seizures.
What is being tested?
The trial is testing whether switching antibiotics to Meropenem or adding an antifungal Micafungin helps in patients whose fevers persist after initial treatment for febrile neutropenia during cancer therapy. It aims to find the best way to revise antimicrobial treatments in these cases.
What are the potential side effects?
Meropenem may cause gastrointestinal issues like nausea and diarrhea; allergic reactions; skin rash; and abnormal liver or kidney tests. Micafungin can lead to similar side effects including potential infusion-related reactions and rarely significant liver damage.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~hour 72
This trial's timeline: 3 weeks for screening, Varies for treatment, and hour 72 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Global Success Rate
Secondary study objectives
Collection of Causes of any proven breakthrough infection while on meropenem or micafungin
Days of therapy of meropenem or micafungin
Hospital length of stay (days)
+3 more

Trial Design

2Treatment groups
Active Control
Group I: Meropenem ArmActive Control1 Intervention
Patients who meet inclusion criteria may be randomized to meropenem (routine standard of care) dose according to local dosing guidelines to include the use of extended-infusions and adjustments to account for renal function. Duration will be managed by the primary team.
Group II: Micafungin ArmActive Control1 Intervention
Patients who meet inclusion criteria may be randomized to micafungin dosed as 150mg intravenously every 24 hours according to local dosing guidelines. Duration will be managed by the primary team.

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,266 Previous Clinical Trials
1,013,587 Total Patients Enrolled
1 Trials studying Febrile Neutropenia
70 Patients Enrolled for Febrile Neutropenia
John Williamson, PharmDPrincipal InvestigatorWake Forest University Health Sciences
1 Previous Clinical Trials
8 Total Patients Enrolled

Media Library

Meropenem (Carbapenem) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05784844 — Phase 4
~80 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top