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

0557-21-HMO

Aminoglycoside (AG) antibiotics have been in clinical use since the 1960s for treating various infections. The main safety concern related to AG use is nephrotoxicity. Based on validated pharmacokinetic-pharmacodynamic (PK-PD) principles shown to predict efficacy, AG dosing has shifted over the past 2 decades from multiple daily dosing to extended-interval dosing, with concomitant reduction in nephrotoxicity. Currently, AG daily dose is calculated according to the patients' adjusted body weight, assuming a common minimal inhibitory concentration (MIC) value. We hypothesize that once pathogen identity and actual MIC become available, AG daily doses may be further adjusted, using the same PK-PD indices. In order to investigate this hypothesis, we are conducting a prospective clinical study in which AG doses will be adjusted based on patient- and pathogen-specific factors, while assessing efficacy and safety.

2021-12-01

2025-12-31

2025-12-31

Recruiting

151

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

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2024-03-01