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Search / Trial NCT05618457

Adjustment of Aminoglycoside Dosing Based on Peak Serum Concentration and Bacterial Minimal Inhibitory Concentration

Launched by HADASSAH MEDICAL ORGANIZATION · Nov 8, 2022

Trial Information

Current as of June 09, 2025

Recruiting

Keywords

Aminoglycosides Minimal Inhibitory Concentration (Mic) Gram Negative Pk/Pd Peak Concentration (Cmax)

ClinConnect Summary

This clinical trial is studying how to better adjust the dosing of aminoglycoside antibiotics, which are used to treat certain infections. The researchers believe that by taking into account the specific bacteria causing the infection and how much of the antibiotic is needed to stop them from growing, they can create a more personalized treatment plan. This approach could potentially improve the effectiveness of the medication while also reducing side effects, particularly kidney damage, which is a known risk with these antibiotics.

To be eligible for the trial, participants must be adults aged 18 or older who are receiving treatment with either gentamycin or amikacin for an approved infection. They should have normal or mildly impaired kidney function and expect to continue their antibiotic treatment for at least four more days. Participants will have their doses adjusted based on their unique circumstances and the specific bacteria involved, and they will be closely monitored for both the effectiveness of the treatment and any possible side effects. If you or a loved one meet these criteria, this trial could provide a chance to receive tailored antibiotic therapy while contributing to important research.

Gender

ALL

Eligibility criteria

  • 1. Adult patients (≥18yr)
  • 2. Any infection treated with IV gentamycin or amikacin and approved by the consultant infectious diseases specialist, excluding neurosurgical infections, pneumonia, endocarditis or endovascular infections
  • 3. Normal renal function or mild renal impairment (eGFR≥40ml/min)
  • 4. On extended-interval AG and an expected remaining AG course of at least 4 days
  • 5. At least one microbiological specimen with identification of an AG-susceptible pathogen and MIC determination and
  • 6. Signed informed consent form
  • Exclusion Criteria:
  • 1. Age\<18yr
  • 2. Neurosurgical infections, pneumonia, endocarditis or endovascular infections
  • 3. eGFR\<40ml/min
  • 4. Empirical aminoglycoside treatment
  • 5. Non Gram-negative pathogen
  • 6. No MIC available for the pathogen
  • 7. Expected remaining treatment duration of less than 4 days

About Hadassah Medical Organization

Hadassah Medical Organization (HMO) is a leading healthcare institution based in Jerusalem, Israel, renowned for its commitment to advancing medical research and improving patient care. As a prominent clinical trial sponsor, HMO leverages its state-of-the-art facilities and multidisciplinary expertise to conduct innovative research across various therapeutic areas. The organization is dedicated to fostering collaboration between clinical researchers, healthcare professionals, and academic institutions, ensuring the highest standards of ethical practice and scientific rigor. HMO's mission is to translate groundbreaking research into effective treatments, ultimately enhancing health outcomes for diverse populations both locally and globally.

Locations

Jerusalem, , Israel

Patients applied

0 patients applied

Trial Officials

Maya Korem, MD

Principal Investigator

Director, Antimicrobial Stewardship Program

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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