NCT02729116

Brief Summary

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 Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2016

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 6, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
7.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

March 8, 2023

Status Verified

March 1, 2023

Enrollment Period

7.4 years

First QC Date

March 24, 2016

Last Update Submit

March 7, 2023

Conditions

Anti-Infective Agents, UrinaryEscherichia Coli InfectionsKlebsiella InfectionsKidney TransplantationUrinary Tract Infections

Keywords

Extended-Spectrum ß-lactamase-producing Escherichia coliExtended-Spectrum ß-lactamase-producing Klebsiella pneumoniaeKidney TransplantationUrinary Tract Infections

Outcome Measures

Primary Outcomes (1)

  • Number of patients with clinical cure of acute urinary tract infection

    No symptoms of acute urinary tract infection

    14 days

Secondary Outcomes (1)

  • Number of patients with micrological cure of acute urinary tract infection

    14 days

Study Arms (2)

Sitafloxacin group

EXPERIMENTAL

Sitafloxacin 100 mg oral twice daily

Drug: Sitafloxacin

Ertapenem group

ACTIVE COMPARATOR

Ertapenem 1 gm IV every 24 h

Drug: Ertapenem

Interventions

SitafloxacinDRUG

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.

Sitafloxacin group
ErtapenemDRUG

Patients are given IV ertapenem for 14 days

Ertapenem group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Khon Kaen University

Ban Khanaen, Khonkaen, 40000, Thailand

Location

Khon Kaen University

Ban Khanaen, Khonkaen, 40002, Thailand

Location

Related Publications (3)

  • Thamlikitkul V, Tiengrim S. In vitro susceptibility test of sitafloxacin against resistant gram-negative bacilli isolated from Thai patients by disk diffusion method. J Med Assoc Thai. 2014 Mar;97 Suppl 3:S7-12.

    PMID: 24772575BACKGROUND

  • Nakamura T, Komatsu M, Yamasaki K, Fukuda S, Higuchi T, Ono T, Nishio H, Sueyoshi N, Kida K, Satoh K, Toda H, Toyokawa M, Nishi I, Sakamoto M, Akagi M, Mizutani T, Nakai I, Kofuku T, Orita T, Zikimoto T, Natsume S, Wada Y. Susceptibility of various oral antibacterial agents against extended spectrum beta-lactamase producing Escherichia coli and Klebsiella pneumoniae. J Infect Chemother. 2014 Jan;20(1):48-51. doi: 10.1016/j.jiac.2013.08.004. Epub 2013 Dec 11.

    PMID: 24462425BACKGROUND

  • Tiengrim S, Phiboonbanakit D, Thunyaharn S, Tantisiriwat W, Santiwatanakul S, Susaengrat W, Srisurat N, Malithong A, Srisangchan P, Thamlikitkul V. Comparative in vitro activity of sitafloxacin against bacteria isolated from Thai patients with urinary tract infections and lower respiratory tract infections. J Med Assoc Thai. 2012 Feb;95 Suppl 2:S6-17.

    PMID: 22574524BACKGROUND

MeSH Terms

Conditions

Escherichia coli InfectionsKlebsiella InfectionsUrinary Tract Infections

Interventions

sitafloxacinErtapenem

Condition Hierarchy (Ancestors)

Enterobacteriaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Carbapenemsbeta-LactamsLactamsAmidesOrganic ChemicalsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 24, 2016

First Posted

April 6, 2016

Study Start

July 1, 2016

Primary Completion

December 1, 2023

Study Completion

January 1, 2024

Last Updated

March 8, 2023

Record last verified: 2023-03

Locations

TH(2)