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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
Study 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.Check my eligibility
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.See study design
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ hour 72
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~hour 72
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Global Success Rate
Secondary outcome measures
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 moreTrial 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.
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Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,243 Previous Clinical Trials
1,004,606 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
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any risks associated with Meropenem Arm treatment?
"There is abundant evidence to suggest that Meropenem Arm is safe, and thus it has been assigned a 3 on our risk assessment scale. This phase 4 trial indicates the treatment has already been approved for public use."
Answered by AI
Are there any available openings for individuals wishing to join this trial?
"As indicated on the clinicaltrials.gov database, this research study opened for recruitment on April 1st 2023 and was last modified 13th March of the same year. Though no longer open to participants, there are now 136 other trials currently enrolling patients."
Answered by AI
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