NCT02575495

Brief Summary

The major hypothesis to be tested is that there was no difference in the clinical outcome between 7(short-course) and 14(traditional-course) days of antibiotic treatment for asymptomatic bacteriuria early after kidney transplantation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2015

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

February 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 8, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 14, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

March 16, 2016

Status Verified

March 1, 2016

Enrollment Period

11 months

First QC Date

October 8, 2015

Last Update Submit

March 15, 2016

Conditions

Kidney TransplantationBacteriuriaAsymptomatic Infections

Outcome Measures

Primary Outcomes (1)

  • Composite end point of Symptomatic urinary tract infection, Sepsis, Graft function and Mortality rate

    Composite end point at 1 month after discontinuing antibiotics

    1 month

Secondary Outcomes (3)

  • Composite end point of Symptomatic urinary tract infection, Sepsis, Graft function and Mortality rate

    0.5 months

  • Composite end point of Symptomatic urinary tract infection, Sepsis, Graft function and

    3 months

  • duration of hospital stay

    30 days since randomization

Study Arms (2)

7 days course of antibiotic treatment

EXPERIMENTAL

To assign the 7 days course of antibiotic treatment, start specific intravenous antibiotic therapy as microbiological susceptibility from urine culture

Drug: 7 days course of antibiotic treatment

14 days course of antibiotic treatment

ACTIVE COMPARATOR

To assign the 14 days course of antibiotic treatment, start specific intravenous antibiotic therapy as microbiological susceptibility from urine culture

Drug: 14 days course of antibiotic treatment

Interventions

7 days course of antibiotic treatmentDRUG

start specific intravenous antibiotic therapy as microbiological susceptibility from urine culture for 7 days

Also known as: short-course antibiotic treatment
7 days course of antibiotic treatment
14 days course of antibiotic treatmentDRUG

start specific intravenous antibiotic therapy as microbiological susceptibility from urine culture for 14 days

Also known as: traditional-course antibiotic treatment
14 days course of antibiotic treatment

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • First kidney transplantation
  • Asymptomatic bacteriuria

You may not qualify if:

  • Refusal to participate in the study
  • Re-transplantation or combined organ transplantation
  • History of abnormal structure or function in native kidney, ureter and bladder system
  • Kidney transplant recipients with history of recurrent urinary tract infection or incomplete course of urinary tract infection treatment before transplantation
  • Hemodynamic unstable
  • Urosepsis or other serious infectious complications(eg. symptomatic urinary tract infection/graft pyelonephritis, surgical site infection, infected urinoma/ hospital acquired pneumonia that mandates antibiotic therapy)
  • Surgical complication (eg. anastomosis leakage, collection, ureteric stricture)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pattraporn Ponglorpisit

Ratchathewi, Bangkok, 10400, Thailand

Location

MeSH Terms

Conditions

BacteriuriaAsymptomatic Infections

Condition Hierarchy (Ancestors)

Urinary Tract InfectionsInfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesAsymptomatic DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Pattraporn Ponglorpisit, MD

    Ramathibodi Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2015

First Posted

October 14, 2015

Study Start

February 1, 2015

Primary Completion

January 1, 2016

Study Completion

February 1, 2016

Last Updated

March 16, 2016

Record last verified: 2016-03

Locations

TH(1)