Clinical Trials Logo
  1. Home
  2. Kidney Transplantation
  3. NCT02729116
  4. Details
NCT02729116 Clinical Trial

Sitafloxacin and Ertapenem Treatment for Acute Urinary Tract Infection Caused by E. Coli or K. Pneumoniae in Post-kidney Transplantation Patients

Kidney Transplantation Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT02729116
Other study ID # HE581520
Secondary ID
Status Active, not recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date July 2016
Est. completion date January 2024

Study information
Verified date March 2023
Source Khon Kaen University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 30
Est. completion date January 2024
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• 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.
• Ertapenem
Patients are given IV ertapenem for 14 days

Locations
Country Name City State
Thailand Khon Kaen University Ban Khanaen Khonkaen
Thailand Khon Kaen University Ban Khanaen Khonkaen

Sponsors (1)
Lead Sponsor Collaborator
Khon Kaen University

Country where clinical trial is conducted

Thailand, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Number of patients with clinical cure of acute urinary tract infection No symptoms of acute urinary tract infection 14 days
Secondary Number of patients with micrological cure of acute urinary tract infection No evidence of Extended Spectrum Beta Lactamase Escherichia coli or Klebsiella pneumoniae in urine culture 14 days
See also
  Status Clinical Trial Phase
Recruiting NCT04910867 - APOL1 Genetic Testing Program for Living Donors N/A
Completed NCT02723591 - To Compare the Effects of Immediate-release Tacrolimus and Astagraf XL on Donor-Specific Antibody (DSA) Formation and the Development of Immune Activation (IA) in de Novo Kidney Transplant Recipients Phase 4
Completed NCT05945511 - Silent Gallbladder Stone in Kidney Transplantation Recipients: Should it be Treated?
Completed NCT02234349 - Bile Acids and Incretins in Pancreas Kidney Transplant Patients N/A
Completed NCT04496401 - PK Study in Diabetic Transplant récipients : From Twice-daily Tacrolimus to Once-daily Extended-release Tacrolimus Phase 4
Recruiting NCT05917795 - Endoscopic Sleeve Gastroplasty With Endomina® for the Treatment of Obesity in Kidney Transplant Candidates N/A
Not yet recruiting NCT05934383 - Safety and Efficacy of Ultrasound Renal Denervation in Kidney Transplantation Patients With Uncontrolled Hypertension N/A
Withdrawn NCT04936971 - Introduction of mTor Inhibitors and the Activation of the Cytomegalovirus (CMV) -Specific Cellular Immune Response Phase 4
Not yet recruiting NCT04540640 - Oxygenated Machine Preservation in Kidney Transplantation N/A
Not yet recruiting NCT03090828 - Economic Evaluation of an Education Platform for Patients With End-stage Renal Disease N/A
Recruiting NCT02908139 - Noninvasive Perioperative Monitoring of Arterial Stiffness, Volume and Nutritional Status in Stable Renal Transplant Recipients N/A
Completed NCT02560558 - Bela 8 Week Dosing Phase 4
Terminated NCT02417870 - Ultra-low Dose Subcutaneous IL-2 in Renal Transplantation Phase 1/Phase 2
Recruiting NCT02154815 - Pre-emptive Kidney Transplantation Quality of Life N/A
Completed NCT02235571 - iChoose Decision Kidney Aid for End-Stage Renal Disease Patients N/A
Enrolling by invitation NCT01905514 - ImPRoving Adherence to Immunosuppressive Therapy by Mobile Internet Application in Solid Organ Transplant Patients N/A
Completed NCT02147210 - Chronic Transplant Glomerulopathy and Regulation of Expression of Ephrin B1 N/A
Recruiting NCT01699360 - The Biomarker for Immunosuppressive Agents Metabolism in Chinese Renal Transplant Recipients Phase 4
Terminated NCT01436305 - Optimization of NULOJIX® Usage As A Means of Avoiding CNI and Steroids in Renal Transplantation Phase 2
Completed NCT01655563 - Pharmacogenetic Trial of Tacrolimus After Pediatric Transplantation Phase 2