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Carbapenem

Observation Treatment Group for Enterobacteriaceae Infections

Phase 4
Waitlist Available
Led By Christopher Polk, MD
Research Sponsored by Atrium Health
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 90 days
Awards & highlights

Study Summary

This trial is comparing the use of IMI/REL to historical data of using MVB and CZA to treat Klebsiella Producing Carbapenemase Enterobacteriaceae infections. The objective is to demonstrate successful treatment of KPC containing Enterobacteriaceae infections with IMI/REL including in bacteremia, and to analyze treatment outcomes in use of IMI/REL for KPC-producing infections compared to historical clinical outcome data with CZA and MVB use at the same institution.

Eligible Conditions
  • Carbapenem-Resistant Enterobacteriaceae (CRE) Infection
  • Gram-Negative Bacterial Infection
  • Klebsiella pneumoniae
  • Antibiotic Resistance

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clinical success
Clinical success by site of infection
Secondary outcome measures
90 day Mortality
Adverse effects
Development of resistance
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Observation Treatment GroupExperimental Treatment1 Intervention
All patients observed while treated with IMI/REL.

Find a Location

Who is running the clinical trial?

Atrium HealthLead Sponsor
121 Previous Clinical Trials
34,854 Total Patients Enrolled
Wake Forest University Health SciencesLead Sponsor
1,239 Previous Clinical Trials
1,004,183 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,886 Previous Clinical Trials
5,054,571 Total Patients Enrolled
1 Trials studying Enterobacteriaceae Infections
813 Patients Enrolled for Enterobacteriaceae Infections

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has this treatment received governmental approval?

"There is ample clinical data to prove this treatment's safety, granting it a rating of 3 on our scale. As the trial has reached Phase 4, the medication has been given regulatory approval."

Answered by AI

Are there any open slots left for participants in this research trial?

"Data from clinicaltrials.gov confirms that this medical trial is presently enrolling participants, with the initial post date of June 7th 2021 and most recent update on June 16th 2022."

Answered by AI

What are the fundamental purposes of this research endeavor?

"This study, with a 30 day evaluation period, seeks to assess Clinical success across infected sites. Secondary goals include determining Total Length of hospital stays (measured in Days of hospitalization for CRE infection), 90 day Mortality (measurement being Survival at 90 days) and Recurrence of infection (calculated as Recurrence of CRE-containing infection within 90 days)."

Answered by AI

How many participants are accepted in this research endeavor?

"Yes, indeed. According to the clinicaltrials.gov data, this study is currently accepting participants and was first added on June 7th 2021. The trial requires 15 patients from one medical facility for successful completion of its protocol."

Answered by AI

Has research of this kind been undertaken previously?

"Presently, there are 6 ongoing trials of this drug in 5 cities and 9 nations. In 2011, Pfizer funded the initial investigation which included 60 individuals that completed Phase 4 clinical approval. Since then, a total of 35 studies have been carried out."

Answered by AI

In what maladies is this particular therapy commonly prescribed?

"This treatment regimen is largely used to address endocarditis caused by staphylococcus aureus, yet it can be utilized in some cases of pyelonephritis, abdominal infection and urinary tract infections."

Answered by AI
~0 spots leftby Apr 2025