Is Prophylactic Antibiotics Necessary In Otherwise Health... | NCT02635490

Studies
Is Prophylactic Antibiotics Necessary In Otherwise Healthy Adult Patients Undergoing Ureteroscopic Procedures for Ureteral Stones?

NCT02635490

Sponsor

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Status

Completed

Last Update Posted

Dec 18, 2015Estimated

Enrollment

52Actual

Phase

Not provided

Conditions

Ureteral Stones

Interventions

Not provided

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2013

Primary Completion Date

Mar 2015Actual

Completion Date

Mar 2015Actual

First Submitted Date

Aug 6, 2014

First Submission Date that Met QC Criteria

Dec 16, 2015

First Posted Date

Dec 18, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 16, 2015

Last Update Posted Date

Dec 18, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Cheng-Hsing Hsieh, Director,Department of Urology, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical FoundationPrincipal Investigator

Lead Sponsor

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical FoundationOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The present study aims to investigate the relative efficacy, safety and risk of a single-dose prophylaxis in otherwise healthy adult patients undergoing ureteroscopic procedures for ureteral stones.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Month

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

52Actual

Label	Type	Description	Intervention Names
prophylactic antibiotics

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evidence of clinically definite urinary tract infection confirmed by urinary analysis or urinary culture.		within the first 10 days (plus or minus 5 days) after surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

100 otherwise healthy adult patients.
Aged from 20 to 65 years.
Undergoing ureteroscopic procedures for ureteral stones.

Exclusion Criteria:

Have the urine road the infection before the surgical operation, the surgical operation once took antibiotics the first 2 week.
Pregnant or the women been breast feeding.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Cohort study

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cheng-Hsing Hsieh		Taipei	Xindian	23142	Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D014552	Urinary Tract Infections

Ancestor Terms

ID	Term
D007239	Infections
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided