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Sitafloxacin and Ertapenem Treatment for Acute Pyelonephritis Caused by Escherichia Coli (SETAP)

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ClinicalTrials.gov Identifier: NCT02537847
Recruitment Status : Unknown
Verified August 2015 by Chitprasong Malaisri, Mahidol University.
Recruitment status was:  Recruiting
First Posted : September 2, 2015
Last Update Posted : September 2, 2015
Sponsor:
Information provided by (Responsible Party):
Chitprasong Malaisri, Mahidol University

Brief Summary:
The aim of the investigators' study was to evaluate oral and non carbapenem antimicrobial agents which can be used in outpatient for the treatment of non-bacteremic acute pyelonephritis caused by Extended Spectrum Beta Lactamase Escherichia coli. This study was conducted to compare the clinical and bacteriological outcomes of patients with non-bacteremic acute pyelonephritis caused by Extended Spectrum Beta Lactamase Escherichia coli who were treated with intravenous (IV) carbapenems followed by oral sitafloxacin or IV ertapenem.

Condition or disease Intervention/treatment Phase
Infection Due to Escherichia Coli Acute Pyelonephritis Drug: Sitafloxacin Drug: Ertapenem Phase 2

Detailed Description:
A prospective randomized controlled trial of patients with a presumptive diagnosis of acute pyelonephritis caused by Extended Spectrum Beta Lactamase-producing pathogen was performed. Carbapenems was initially given to all patients. After day 3, patients were randomized to receive either oral sitafloxacin (100 mg twice daily) or intravenous ertapenem. The regular course of treatment was completed within 10 days.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Sitafloxacin and Ertapenem Treatment for Acute Pyelonephritis Caused by Extended-Spectrum ß-lactamase-producing Escherichia Coli
Study Start Date : November 2012
Estimated Primary Completion Date : September 2015
Estimated Study Completion Date : May 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sitafloxacin group
The first third days of treatment was open label and all patients were given intravenous carbapenems. After day 3, the patients were randomized to either sitafloxacin group or ertapenem group by the use of a computer-generated random number allocation schedule and block size of four. The patients were allocated to the sitafloxacin group or ertapenem group using the sealed envelope method.
Drug: Sitafloxacin
The patients in intervention group will receive carbapenem for the first 3 days then sitafloxacin for 7 days. Total of treatment duration is 10 days.
Other Name: fluoroquinolone

Active Comparator: control group
Intervention was prescribed ertapenem for patients.
Drug: Ertapenem
Control group will be given ertapenem only for 10 days.
Other Name: carbapenem




Primary Outcome Measures :
  1. no symptoms of urinary tract infection [ Time Frame: 30 days ]
    no fever, dysuria, back pain, nausea and vomiting


Secondary Outcome Measures :
  1. no evidence of Extended Spectrum Beta Lactamase Escherichia coli in urine culture [ Time Frame: 30 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age >18 years
  • Acute pyelonephritis by definition
  • Positive urine culture for Extended Spectrum Beta Lactamase Escherichia coli ≥105 colony forming unit/mL
  • Voluntarily consented to be enrolled in the study

Exclusion Criteria:

  • Severe sepsis or septic shock
  • Mixed organism of urine culture
  • Positive blood culture
  • Has other source of infection
  • Has mechanical abnormality of urinary tract
  • Immunocompromised conditions
  • Retained Foley's catheter
  • Pregnancy or lactation
  • Previous urinary tract infections within 4 weeks
  • Contraindicated for fluoroquinolones and carbapenems

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02537847


Contacts
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Contact: Chitprasong Malaisri, MD +66 89 466 5043 Mchitprasong@yahoo.com

Locations
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Thailand
Faculty of Medicine Ramathibodi Hospital Recruiting
Bangkok, Thailand, 10400
Contact: Chitprasong Malaisri, MD    ++66 89 466 5043    Mchitprasong@yahoo.com   
Sponsors and Collaborators
Mahidol University
Investigators
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Study Director: Sasisopin Kiertiburanakul Ramathibodi Hospital Mahidol University
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Responsible Party: Chitprasong Malaisri, Ramathibodi Hospital, Mahidol University
ClinicalTrials.gov Identifier: NCT02537847    
Other Study ID Numbers: Sitafloxacin123
First Posted: September 2, 2015    Key Record Dates
Last Update Posted: September 2, 2015
Last Verified: August 2015
Keywords provided by Chitprasong Malaisri, Mahidol University:
Sitafloxacin
Extended-Spectrum ß-lactamase-producing Escherichia coli
Treatment for Acute Pyelonephritis
Ertapenem
Additional relevant MeSH terms:
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Escherichia coli Infections
Pyelonephritis
Nephritis, Interstitial
Nephritis
Kidney Diseases
Urologic Diseases
Pyelitis
Enterobacteriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Ertapenem
Fluoroquinolones
Sitafloxacin
Anti-Bacterial Agents
Anti-Infective Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Antineoplastic Agents