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Observation Treatment Group for Enterobacteriaceae Infections
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.
- Carbapenem-Resistant Enterobacteriaceae (CRE) Infection
- Gram-Negative Bacterial Infection
- Klebsiella pneumoniae
- Antibiotic Resistance
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Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Frequently Asked Questions
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."
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."
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)."
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."
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."
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."
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