Efficacy and safety of amikacin versus ertapenem as definitive antibiotic therapy for complicated urinary tract infections caused by ceftriaxone resistance Escherichia coli or Klebsiella pneumoniae: an open-label, randomized, controlled, non-inferiority clinical trial

Efficacy and safety of amikacin versus ertapenem as definitive antibiotic therapy for complicated urinary tract infections caused by ceftriaxone resistance Escherichia coli or Klebsiella pneumoniae: an open-label, randomized, controlled, non-inferio

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

TCTR

Registry ID

TCTR20190924001

Enrollment

102

Registered

2019-09-24

Start date

2019-09-23

Completion date

Unknown

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complicated urinary tract infections with Escherichia coli or Klebsiella pneumoniae and ceftriaxone resistance Amikacin&#44

Interventions

dilute 500 mg in 100&#45

200 ml NS&#44

D5W or D5NS intravenous over 30 minutes dose: CrCl>60ml/min

15mg/kg q24hr&#44

CrCl60&#45

40ml/min

15mg/kg q36hr&#44

CrCl40&#45

20ml/min

15mg/kg q48hr,reconstitute 1&#44

000 mg with 10 ml of sterile water for injection or NS

transfer to 50 ml of NS intravenous over 30 minutes dose: CrCl>30ml/min

1&#44

000mg q24hr&#44

CrCl<&#44

=30ml/min

500mg q24hr

Experimental Drug,Active Comparator Drug

Amikacin,Ertapenem

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age â‰¥ 18 years, 2. Documented or suspected cUTI or AP, 3. Positive urine culture (â‰¥ 105 colony-forming units/ml) that resistance to ceftriaxone but sensitivity to amikacin and ertapenem

Exclusion criteria

Exclusion criteria: 1. other infection besides urinary tract infection 2. positive hemoculture 3. hypotension that vasopressors required to achieve a mean arterial pressure â‰¥ 65 mmHg 4. AKI is defined by Kidney Disease: Improving Global Outcomes (KDIGO) 2012 5. kidney transplantation, hemodialysis or peritoneal dialysis 6. creatinine clearance < 20 ml/min as estimated by the Cockcroft-Gault formula 7. pregnancy, lactation or preparing for pregnancy during study period 8. known allergy and intolerance to any aminoglycosides or carbapenems

Design outcomes

Primary

Measure	Time frame
Clinical cure end of treatment All the core symptoms of complicated urinary tract infection are resolution or return to baseline an	—

Secondary

Measure	Time frame
Microbiological cure end of treatment Pathogen that found at screening in urine culture reduced to <103 cfu/ml,Overall success end of treatment Microbiological eradication and Clinical cure,Clinical sustained cure late follow-up All the core symptoms of complicated urinary tract infection are no worsening at end of treatment un,microbiological sustained eradication late follow-up Microbiological sustained eradication or presumed sustained eradication of pathogen that found at sc,mortality rate since enrollment until end of study Overall mortality since enrolment until end of study ,Acute kidney injury since enrollment until end of treatment Classify by Kidney Disease: Improving Global Outcomes (KDIGO), 2012	—

Measure

Time frame

Microbiological cure end of treatment Pathogen that found at screening in urine culture reduced to <103 cfu/ml,Overall success end of treatment Microbiological eradication and Clinical cure,Clinical sustained cure late follow-up All the core symptoms of complicated urinary tract infection are no worsening at end of treatment un,microbiological sustained eradication late follow-up Microbiological sustained eradication or presumed sustained eradication of pathogen that found at sc,mortality rate since enrollment until end of study Overall mortality since enrolment until end of study ,Acute kidney injury since enrollment until end of treatment Classify by Kidney Disease: Improving Global Outcomes (KDIGO), 2012

—

Countries

Thailand

Contacts

Public ContactSirima Sitaruno

Faculty of Pharmaceutical Sciences, Prince of Songkla University

sirima@pharmacy.psu.ac.th0887900798

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Apr 4, 2026

Efficacy and safety of amikacin versus ertapenem as definitive antibiotic therapy for complicated urinary tract infections caused by ceftriaxone resistance Escherichia coli or Klebsiella pneumoniae: an open&#45;label&#44; randomized&#44; controlled&#44; non&#45;inferiority clinical trial