NCT01768364

Brief Summary

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

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
124

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

January 14, 2013

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 15, 2013

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

January 15, 2013

Status Verified

January 1, 2013

Enrollment Period

3 years

First QC Date

January 14, 2013

Last Update Submit

January 14, 2013

Conditions

Ureteric Stent After Stone Surgery

Outcome Measures

Primary Outcomes (1)

  • 14 days infection rate w/wo antibiotics

    14 days

Secondary Outcomes (1)

  • infection rate with ureter stent wo antibiotics

    14 days

Study Arms (2)

Antibiotics

ACTIVE COMPARATOR

will receive antibiotics

Drug: Trimetoprim-Sulfa (Bactrim)

No antibiotics

ACTIVE COMPARATOR

will not receive antibiotics

Other: No antibiotics

Interventions

Trimetoprim-Sulfa (Bactrim)DRUG
Antibiotics
No antibioticsOTHER
No antibiotics

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • ongoing antibiotic treatment, allergy to trimetoprim-sulfa

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akershus University Hospital

Lorenskog, Lorenskog, 1478, Norway

Location

MeSH Terms

Interventions

Trimethoprim, Sulfamethoxazole Drug Combination

Intervention Hierarchy (Ancestors)

SulfamethoxazoleBenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsSulfanilamidesAniline CompoundsAminesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsTrimethoprimPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDrug CombinationsPharmaceutical Preparations

Study Officials

  • Tor Erik Sand, MD. PhD

    University Hospital, Akershus

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tor Erik Sand, MD, PhD

CONTACT

tor.erik.sand@ahus.no

Manuela Estop-Garanto, MD

CONTACT

mnet@ahus.no

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor, M.D., Ph.D.

Study Record Dates

First Submitted

January 14, 2013

First Posted

January 15, 2013

Study Start

January 1, 2013

Primary Completion

January 1, 2016

Study Completion

April 1, 2016

Last Updated

January 15, 2013

Record last verified: 2013-01

Locations

NO(1)