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Fixed-dose Amikacin for Elderly UTI

NCT04197739 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2019-12-13

No results posted yet for this study

Summary

Aminoglycosides are broad-spectrum antibiotics, effective against gram-negative bacteria. Aminoglycosides urine concentration exceeds that of the plasma by up to a hundred. Their efficacy is dependent on their level above minimal inhibitory concentration (MIC); however high levels are associate with nephrotoxicity. Therefore aminoglycosides have a narrow therapeutic rang. The correlation between administrated dose and blood drug levels is hard to predict. Amikacin is a highly effective aminoglycoside, highly effective against extended spectrum beta lactamase (ESBL) bacteria.

Older patients suffer from more urinary tract infection (UTIs), and have a higher frequency of infection with resistant bacteria, mainly among frail nursing home residents.

Our goal is to prove that fixed low dose amikacin in the elderly patient in non-inferior to weight-adjusted treatment.

Study design:

A randomized prospective, open label, non-inferiority trial

Study participants will be 65 years or older, who were admitted to the medical ward due to a UTI will be assigned to one of the following study arms:

1. Intervention arm: in which patients will receive a fixed dose of amikacin, 500 mg, once a day.
2. Comparator arm: in which patients will receive a weight adjusted dose of amikacin (15 mg/kg adjusted body weight) and continue in adjusted intervals according plasma concentrations, using the Barnes Jewish Hospital nomogram.

All participants will be followed up with:

1. Amikacin blood levels 6-14 hours following first administration, used for dose adjustment according to the nomogram. Peak amikacin blood levels, 30- 60 minutes following first or second administration.
2. Urine analysis and culture upon admission to the emergency department (ER). In patients with indwelling urinary catheters, cultures will be taken following replacement with a new catheter.
3. Broad serum biochemistry, complete blood count, C-reactive protein and blood cultures will be taken upon admission to the ER, two days after recruitment and at least once every three days following that, as long as the patient is receiving amikacin.

Duration of amikacin treatment will be according to the attending physician's clinical judgment; however, it will not be shorter than 72 hours since first dose. Total duration of amikacin treatment will not exceed 10 days. Total treatment for UTI will not fall short of seven days of antibiotics (either amikacin or any suitable alterative according to blood and/or urine cultures).

Conditions

Interventions

DRUG

Amikacin

Patients in the intervention arm will receive a fixed, single daily dose of amikacin, 500 mg, a day. Patients in the Comparator arm will receive a weight adjusted loading dose of amikacin (15 mg/kg adjusted body weight) and continue in adjusted intervals according to the Barnes Jewish Hospital nomogram

Sponsors & Collaborators

  • Rabin Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-31
Primary Completion
2021-12-31
Completion
2021-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04197739 on ClinicalTrials.gov