Adjusting aminoglycoside doses based on patient and pathogen factors
Adjustment of Aminoglycoside Dosing Based on Peak Serum Concentration and Bacterial Minimal Inhibitory Concentration
NA · Hadassah Medical Organization · NCT05618457
This study tests if adjusting the dose of aminoglycoside antibiotics based on individual patient and infection details can help people get better while reducing kidney damage.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 151 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hadassah Medical Organization (other) |
| Locations | 1 site (Jerusalem) |
| Trial ID | NCT05618457 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the adjustment of aminoglycoside antibiotic dosing based on peak serum concentration and the minimal inhibitory concentration (MIC) of the pathogen. The study aims to optimize dosing by calculating the Cmax/MIC ratio and adjusting the dose accordingly to improve efficacy while minimizing nephrotoxicity. Patients will have their doses tailored based on individual and pathogen-specific factors, with careful monitoring of clinical outcomes and renal function. The trial will involve additional blood sampling for timely peak level determination to ensure accurate dosing adjustments.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with infections treated with IV gentamycin or amikacin and normal to mild renal impairment.
Not a fit: Patients with neurosurgical infections, pneumonia, endocarditis, or those with severe renal impairment will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective treatment of infections while reducing the risk of kidney damage associated with aminoglycoside use.
How similar studies have performed: Other studies have shown promise in optimizing aminoglycoside dosing based on pharmacokinetic and pharmacodynamic principles, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Jerusalem
- Hadassah Hebrew University Medical Center — Jerusalem, Israel (RECRUITING)
Study contacts
- Principal investigator: Maya Korem, MD — Director, Antimicrobial Stewardship Program
- Study coordinator: Ehud Horwitz, PhD
- Email: ehud.horwitz@mail.huji.ac.il
- Phone: +972502799755
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Aminoglycoside Dosing Based on PK/PD Characteristics, Aminoglycosides, Minimal Inhibitory Concentration, Gram negative, PK/PD, Peak concentration