Clinical trial

HE581520

Name

HE581520

Description

This study evaluates oral antimicrobial agents for the treatment of non-bacteremic acute urinary tract infection caused by Extended Spectrum Beta Lactamase producing Escherichia coli or Klebsiella pneumoniae in Post-kidney transplantation. Patients are treated with intravenous (IV) antibiotics follow by oral sitafloxacin or IV ertapenem.

Trial arms

Trial start

2016-07-01

Estimated PCD

2023-12-01

Trial end

2024-01-01

Status

Active (not recruiting)

Phase

Early phase I

Treatment

Sitafloxacin

Patients are given intravenous empirical antibiotics for 3 days. The patients are allocated to the sitafloxacin group or ertapenem group using of a computer-generated random number allocation schedule and block size of four.

Arms:

Sitafloxacin group

Ertapenem

Patients are given IV ertapenem for 14 days

Arms:

Ertapenem group

Size

Primary endpoint

Number of patients with clinical cure of acute urinary tract infection

14 days

Eligibility criteria

Inclusion Criteria: * Age \>18 years * Acute urinary infection by definitions * Positive urine culture for Extended Spectrum Beta Lactamase E. coli or K. pneumoniae ≥105 colony forming unit/mL * Post-kidney transplantation * Voluntarily consented to be enrolled in the study Exclusion Criteria: * Sepsis * Positive blood culture * Mixed organism of urine culture * Immunocompromised conditions other than post-kidney transplantation * Pregnancy or lactation * Previous urinary tract infections within 4 weeks * Contraindicated for fluoroquinolones and carbapenems

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}

Updated at

2023-03-08

1 organization

2 products

6 indications

Organization

Khon Kaen University

Product

Sitafloxacin

Indication

Anti-Infective Agents

Indication