NCT02537847

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.

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
96

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2012

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

August 2, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 2, 2015

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

September 2, 2015

Status Verified

August 1, 2015

Enrollment Period

2.8 years

First QC Date

August 2, 2015

Last Update Submit

August 28, 2015

Conditions

Infection Due to Escherichia ColiAcute Pyelonephritis

Keywords

SitafloxacinExtended-Spectrum ß-lactamase-producing Escherichia coliTreatment for Acute PyelonephritisErtapenem

Outcome Measures

Primary Outcomes (1)

  • no symptoms of urinary tract infection

    no fever, dysuria, back pain, nausea and vomiting

    30 days

Secondary Outcomes (1)

  • no evidence of Extended Spectrum Beta Lactamase Escherichia coli in urine culture

    30 days

Study Arms (2)

Sitafloxacin group

EXPERIMENTAL

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

control group

ACTIVE COMPARATOR

Intervention was prescribed ertapenem for patients.

Drug: Ertapenem

Interventions

SitafloxacinDRUG

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.

Also known as: fluoroquinolone
Sitafloxacin group
ErtapenemDRUG

Control group will be given ertapenem only for 10 days.

Also known as: carbapenem
control group

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine Ramathibodi Hospital

Bangkok, Bangkok, 10400, Thailand

RECRUITING

MeSH Terms

Conditions

Escherichia coli Infections

Interventions

sitafloxacinFluoroquinolonesErtapenemCarbapenems

Condition Hierarchy (Ancestors)

Enterobacteriaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compoundsbeta-LactamsLactamsAmidesOrganic Chemicals

Study Officials

  • Sasisopin Kiertiburanakul

    Ramathibodi Hospital Mahidol University

    STUDY DIRECTOR

Central Study Contacts

Chitprasong Malaisri, MD

CONTACT

+66 89 466 5043Mchitprasong@yahoo.com

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
Ramathibodi Hospital

Study Record Dates

First Submitted

August 2, 2015

First Posted

September 2, 2015

Study Start

November 1, 2012

Primary Completion

September 1, 2015

Study Completion

May 1, 2016

Last Updated

September 2, 2015

Record last verified: 2015-08

Locations

TH(1)