Trial Outcomes & Findings for Restricted Reporting for Positive Urine Cultures (NCT NCT02797613)

NCT ID: NCT02797613

Last Updated: 2020-02-27

Results Overview

Sum of urinary tract infection treated and asymptomatic bacteriuria not treated

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 110 participants
• Primary outcome timeframe: 72 hours from positive culture
• Results posted on: 2020-02-27

Participant Flow

Participant milestones

Measure	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" 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	Standard Reporting Microbiology laboratory will report identification and susceptibility results
Overall Study STARTED	55	55
Overall Study COMPLETED	55	55
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Restricted Reporting n=55 Participants 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	Standard Reporting n=55 Participants Microbiology laboratory will report identification and susceptibility results	Total n=110 Participants Total of all reporting groups
Age, Continuous	67.7 years STANDARD_DEVIATION 16.3 • n=55 Participants	68.6 years STANDARD_DEVIATION 16.0 • n=55 Participants	68.1 years STANDARD_DEVIATION 16.1 • n=110 Participants
Sex: Female, Male Female	35 Participants n=55 Participants	36 Participants n=55 Participants	71 Participants n=110 Participants
Sex: Female, Male Male	20 Participants n=55 Participants	19 Participants n=55 Participants	39 Participants n=110 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Canada	55 participants n=55 Participants	55 participants n=55 Participants	110 participants n=110 Participants
Asymptomatic Bacteriuria	35 Participants n=55 Participants	41 Participants n=55 Participants	76 Participants n=110 Participants

PRIMARY outcome

Timeframe: 72 hours from positive culture

Population: Intention to treat

Sum of urinary tract infection treated and asymptomatic bacteriuria not treated

Outcome measures

Measure	Restricted Reporting n=55 Participants 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	Standard Reporting n=55 Participants Microbiology laboratory will report identification and susceptibility results
The Number of Patients Receiving Appropriate Treatment	44 Participants	29 Participants

Adverse Events

Restricted Reporting

Serious events: 0 serious events

Other events: 7 other events

Deaths: 2 deaths

Standard Reporting

Serious events: 0 serious events

Other events: 9 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Restricted Reporting n=55 participants at risk 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	Standard Reporting n=55 participants at risk Microbiology laboratory will report identification and susceptibility results
Blood and lymphatic system disorders Bacteremia	1.8% 1/55 • Number of events 1 • 7 days after positive urine culture Bacteremia and Death reported at 7 days follow up, Adverse events (systemic inflammatory response syndrome) reported at 72 hours follow up	3.6% 2/55 • Number of events 2 • 7 days after positive urine culture Bacteremia and Death reported at 7 days follow up, Adverse events (systemic inflammatory response syndrome) reported at 72 hours follow up
Cardiac disorders Tachycardia	7.3% 4/55 • Number of events 4 • 7 days after positive urine culture Bacteremia and Death reported at 7 days follow up, Adverse events (systemic inflammatory response syndrome) reported at 72 hours follow up	9.1% 5/55 • Number of events 5 • 7 days after positive urine culture Bacteremia and Death reported at 7 days follow up, Adverse events (systemic inflammatory response syndrome) reported at 72 hours follow up
Blood and lymphatic system disorders Edema	1.8% 1/55 • Number of events 1 • 7 days after positive urine culture Bacteremia and Death reported at 7 days follow up, Adverse events (systemic inflammatory response syndrome) reported at 72 hours follow up	1.8% 1/55 • Number of events 1 • 7 days after positive urine culture Bacteremia and Death reported at 7 days follow up, Adverse events (systemic inflammatory response syndrome) reported at 72 hours follow up
General disorders Abnormal Body Temperature	0.00% 0/55 • 7 days after positive urine culture Bacteremia and Death reported at 7 days follow up, Adverse events (systemic inflammatory response syndrome) reported at 72 hours follow up	0.00% 0/55 • 7 days after positive urine culture Bacteremia and Death reported at 7 days follow up, Adverse events (systemic inflammatory response syndrome) reported at 72 hours follow up
Endocrine disorders Hyperglycaemia	0.00% 0/55 • 7 days after positive urine culture Bacteremia and Death reported at 7 days follow up, Adverse events (systemic inflammatory response syndrome) reported at 72 hours follow up	0.00% 0/55 • 7 days after positive urine culture Bacteremia and Death reported at 7 days follow up, Adverse events (systemic inflammatory response syndrome) reported at 72 hours follow up
Blood and lymphatic system disorders Elevated White Blood Cell Count	0.00% 0/55 • 7 days after positive urine culture Bacteremia and Death reported at 7 days follow up, Adverse events (systemic inflammatory response syndrome) reported at 72 hours follow up	5.5% 3/55 • Number of events 3 • 7 days after positive urine culture Bacteremia and Death reported at 7 days follow up, Adverse events (systemic inflammatory response syndrome) reported at 72 hours follow up
Nervous system disorders Altered Mental Status	3.6% 2/55 • Number of events 2 • 7 days after positive urine culture Bacteremia and Death reported at 7 days follow up, Adverse events (systemic inflammatory response syndrome) reported at 72 hours follow up	9.1% 5/55 • Number of events 5 • 7 days after positive urine culture Bacteremia and Death reported at 7 days follow up, Adverse events (systemic inflammatory response syndrome) reported at 72 hours follow up
Respiratory, thoracic and mediastinal disorders Tachypnea	0.00% 0/55 • 7 days after positive urine culture Bacteremia and Death reported at 7 days follow up, Adverse events (systemic inflammatory response syndrome) reported at 72 hours follow up	5.5% 3/55 • Number of events 3 • 7 days after positive urine culture Bacteremia and Death reported at 7 days follow up, Adverse events (systemic inflammatory response syndrome) reported at 72 hours follow up

Additional Information

Peter Daley

Memorial University

Phone: 7097250240

Email: pkd336@mun.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place