Clinical trial NCT02729116: Sitafloxacin and Ertapenem Treatment for Acute Urinary Tract Infection Caused by E. Coli or K. Pneumoniae in Post-kidney Transplantation Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Anti-Infective Agents, Urinary
Escherichia Coli Infections
Klebsiella Infections
Kidney Transplantation
Urinary Tract Infections
Keywords: Extended-Spectrum ß-lactamase-producing Escherichia coli
Extended-Spectrum ß-lactamase-producing Klebsiella pneumoniae
Kidney Transplantation
Urinary Tract Infections
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
First posted: 2016-04-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: A prospective randomized controlled trial of patients with a presumptive diagnosis of acute urinary tract infection caused by Extended Spectrum Beta Lactamase-producing Escherichia coli or Klebsiella pneumoniae in Post-kidney transplantation. Intravenous (IV) antibiotic is initially given to all patients. After day 3, patients were randomized to receive either oral sitafloxacin (100 mg twice daily) or intravenous ertapenem. The course of treatment will complete within 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

Primary outcomes:
measure: Number of patients with clinical cure of acute urinary tract infection
timeFrame: 14 days
Secondary outcomes:
measure: Number of patients with micrological cure of acute urinary tract infection
timeFrame: 14 days
Other outcomes:
Locations:
city: Ban Khanaen
country: Thailand
facility: Khon Kaen University
state: Khonkaen
city: Ban Khanaen
country: Thailand
facility: Khon Kaen University
state: Khonkaen
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.