Restricted Reporting for Positive Urine Cultures

• Sponsor: Memorial University of Newfoundland (Other)
• Overall Status: Completed
• CT.gov ID: NCT02797613
• Collaborator: (none)
• Enrollment: 110
• Location: 1
• Arms: 2
• Actual Duration (Months): 3.9
• Patients Per Site Per Month: 27.9

Study Details

Study Description

Brief Summary

Asymptomatic bacteriuria (AB) is a condition in which bacteria are detected in urine culture without urinary symptoms. The inappropriate use of antibiotic treatment for AB selects bacterial flora to express resistance mutations. Reducing inappropriate antibiotic use for AB is difficult, since the microbiology laboratory cannot distinguish patients with AB. The investigators study will use a restricted laboratory report requesting the physician to call the laboratory for culture results. The restricted report may reduce the rate of inappropriate treatment of AB.

Condition or Disease	Intervention/Treatment	Phase
Bacteriuria; Urinary Tract Infection	Behavioral: Restricted Reporting	N/A

Detailed Description

Positive urine cultures during the study period will be randomized to restricted microbiology laboratory reporting or standard microbiology laboratory reporting. Physician or patient consent will not be collected. Patient records will be assessed by the investigator to determine if patients have AB or urinary tract infection. Physician antibiotic treatment decision in both groups will be collected.

Study Design

• Study Type: Interventional
• Actual Enrollment: 110 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Treatment
• Official Title: Restricted Reporting for Positive Urine Cultures Randomized Controlled Trial
• Actual Study Start Date: Jan 1, 2017
• Actual Primary Completion Date: May 1, 2017
• Actual Study Completion Date: May 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Restricted Reporting Microbiology laboratory will report "Positive urine cultures may represent asymptomatic bacteriuria or urinary tract infection. If urinary tract infection is suspected clinically, please call 777-xxxx (researcher mobile phone) for identification and susceptibility results"	Behavioral: Restricted Reporting; An abbreviated version of the microbiology report indicating that growth is present and the physician should call the lab for further details if clinically important
No Intervention: Standard Reporting Microbiology laboratory will report identification and susceptibility results

Outcome Measures

Primary Outcome Measures

1. The Number of Patients Receiving Appropriate Treatment [72 hours from positive culture]

   Sum of urinary tract infection treated and asymptomatic bacteriuria not treated

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• positive urine culture from inpatients at Health Sciences Centre or St. Clare's Mercy Hospital or outpatients during study period.

Exclusion Criteria:

• pregnancy,

• antibiotic treatment at the time of urine collection,

• collection from an indwelling catheter,

• admission to long term care facility.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Health Sciences Center	Saint John's	Newfoundland and Labrador	Canada	A1B3V6

Sponsors and Collaborators

• Memorial University of Newfoundland

Investigators

• Principal Investigator: Peter Daley, MD FRCPC, Memorial University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 26, 2016

More Information

Publications

None provided.

• Responsible Party: Peter Daley, Assistant Professor, Memorial University of Newfoundland
• ClinicalTrials.gov Identifier: NCT02797613
• Other Study ID Numbers: MUN-01
• First Posted: Jun 13, 2016
• Last Update Posted: Feb 27, 2020
• Last Verified: Feb 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Urinary Tract Infections; Bacteriuria

Study Results

Participant Flow

Arm/Group Title	Restricted Reporting	Standard Reporting
Arm/Group Description	Microbiology laboratory will report "Positive urine cultures may represent asymptomatic bacteriuria or urinary tract infection. If urinary tract infection is suspected clinically, please call 777-xxxx (researcher mobile phone) for identification and susceptibility results" Restricted Reporting: An abbreviated version of the microbiology report indicating that growth is present and the physician should call the lab for further details if clinically important	Microbiology laboratory will report identification and susceptibility results
Period Title: Overall Study
STARTED	55	55
COMPLETED	55	55
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Restricted Reporting	Standard Reporting	Total
Arm/Group Description	Microbiology laboratory will report "Positive urine cultures may represent asymptomatic bacteriuria or urinary tract infection. If urinary tract infection is suspected clinically, please call 777-xxxx (researcher mobile phone) for identification and susceptibility results" Restricted Reporting: An abbreviated version of the microbiology report indicating that growth is present and the physician should call the lab for further details if clinically important	Microbiology laboratory will report identification and susceptibility results	Total of all reporting groups
Overall Participants	55	55	110
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	67.7 (16.3)	68.6 (16.0)	68.1 (16.1)
Sex: Female, Male (Count of Participants)
Female	35 63.6%	36 65.5%	71 64.5%
Male	20 36.4%	19 34.5%	39 35.5%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
Canada	55 100%	55 100%	110 100%
Asymptomatic Bacteriuria (Count of Participants)
Count of Participants [Participants]	35 63.6%	41 74.5%	76 69.1%

Outcome Measures

1. Primary Outcome

Title	The Number of Patients Receiving Appropriate Treatment
Description	Sum of urinary tract infection treated and asymptomatic bacteriuria not treated
Time Frame	72 hours from positive culture

Outcome Measure Data

Analysis Population Description

Intention to treat

Arm/Group Title	Restricted Reporting	Standard Reporting
Arm/Group Description	Microbiology laboratory will report "Positive urine cultures may represent asymptomatic bacteriuria or urinary tract infection. If urinary tract infection is suspected clinically, please call 777-xxxx (researcher mobile phone) for identification and susceptibility results" Restricted Reporting: An abbreviated version of the microbiology report indicating that growth is present and the physician should call the lab for further details if clinically important	Microbiology laboratory will report identification and susceptibility results
Measure Participants	55	55
Count of Participants [Participants]	44 80%	29 52.7%

Adverse Events

Time Frame	7 days after positive urine culture
Adverse Event Reporting Description	Bacteremia and Death reported at 7 days follow up, Adverse events (systemic inflammatory response syndrome) reported at 72 hours follow up
Arm/Group Title	Restricted Reporting		Standard Reporting
Arm/Group Description	Microbiology laboratory will report "Positive urine cultures may represent asymptomatic bacteriuria or urinary tract infection. If urinary tract infection is suspected clinically, please call 777-xxxx (researcher mobile phone) for identification and susceptibility results" Restricted Reporting: An abbreviated version of the microbiology report indicating that growth is present and the physician should call the lab for further details if clinically important		Microbiology laboratory will report identification and susceptibility results
All Cause Mortality
	Restricted Reporting		Standard Reporting
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/55 (3.6%)		1/55 (1.8%)
Serious Adverse Events
	Restricted Reporting		Standard Reporting
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/55 (0%)		0/55 (0%)
Other (Not Including Serious) Adverse Events
	Restricted Reporting		Standard Reporting
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/55 (12.7%)		9/55 (16.4%)
Blood and lymphatic system disorders
Bacteremia	1/55 (1.8%)	1	2/55 (3.6%)	2
Edema	1/55 (1.8%)	1	1/55 (1.8%)	1
Elevated White Blood Cell Count	0/55 (0%)	0	3/55 (5.5%)	3
Cardiac disorders
Tachycardia	4/55 (7.3%)	4	5/55 (9.1%)	5
Endocrine disorders
Hyperglycaemia	0/55 (0%)	0	0/55 (0%)	0
General disorders
Abnormal Body Temperature	0/55 (0%)	0	0/55 (0%)	0
Nervous system disorders
Altered Mental Status	2/55 (3.6%)	2	5/55 (9.1%)	5
Respiratory, thoracic and mediastinal disorders
Tachypnea	0/55 (0%)	0	3/55 (5.5%)	3

Limitations/Caveats

Our design is a proof-of-concept which will require additional trials to verify. It would be impractical to manually screen all inpatient urine specimens using our inclusion criteria, although automated eligibility screening may be possible.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.