Antibiotic Prophylaxis When Removing Ureteric Stent After... | NCT01768364

Studies
Antibiotic Prophylaxis When Removing Ureteric Stent After Stone Surgery

NCT01768364

Sponsor

Tor Erik Sand

Status

Unknown status

Last Update Posted

Jan 15, 2013Estimated

Enrollment

124Estimated

Phase

Not Applicable

Conditions

Ureteric Stent After Stone Surgery

Interventions

Trimetoprim-Sulfa (Bactrim)
No antibiotics

Countries

Norway

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

Jan 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

Jan 2016Estimated

Completion Date

Apr 2016Estimated

First Submitted Date

Jan 14, 2013

First Submission Date that Met QC Criteria

Jan 14, 2013

First Posted Date

Jan 15, 2013Estimated

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

Jan 14, 2013

Last Update Posted Date

Jan 15, 2013Estimated

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

Is there anything to gain in giving antibiotics as prophylaxis when removing ureteric stents cystoscopically after stone surgery?

Detailed Description

Many patients undergoing stone surgery receive a ureteric stent that should be removed after 14 days. This stent is removed cystoscopically and today this is done without giving antibiotics. Some patients get urinary tract infections subject to this. However the investigators do not know how many of these patients get UTI as most are followed by their primary care doctor. With this study the investigators would like to find out whether it is possible to avoid such infections and also find out how many actually do get infected.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

124Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Antibiotics	Active Comparator	will receive antibiotics	Drug: Trimetoprim-Sulfa (Bactrim)
No antibiotics	Active Comparator	will not receive antibiotics	Other: No antibiotics

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Trimetoprim-Sulfa (Bactrim)	Drug		Antibiotics
No antibiotics

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
14 days infection rate w/wo antibiotics		14 days

Secondary Outcomes

Measure	Description	Time Frame
infection rate with ureter stent wo antibiotics		14 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

stone surgery patients with ureteric stent that should be removed after 14 days

Exclusion Criteria:

ongoing antibiotic treatment, allergy to trimetoprim-sulfa

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Tor Erik Sand, MD, PhD	Contact			tor.erik.sand@ahus.no
Manuela Estop-Garanto, MD	Contact			mnet@ahus.no

Overall Officials

Name	Affiliation	Role
Tor Erik Sand, MD. PhD	University Hospital, Akershus	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Akershus University Hospital		Lorenskog	Lorenskog	1478	Norway

Intervention Browse Module

MeSH Terms

ID	Term
D015662	Trimethoprim, Sulfamethoxazole Drug Combination

Ancestor Terms

ID	Term
D013420	Sulfamethoxazole
D000096926	Benzenesulfonamides
D013449	Sulfonamides
D000577	Amides

Browse Leaves

Not provided

Browse Branches

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