Trial Outcomes & Findings for Modified Reporting of Positive Urine Cultures Collected From Long Term Care (NCT NCT03554603)

NCT ID: NCT03554603

Last Updated: 2024-03-01

Results Overview

Number of Participants Who Received Appropriate Antibiotic Treatment

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 100 participants
• Primary outcome timeframe: 7 days
• Results posted on: 2024-03-01

Participant Flow

Participant milestones

Measure	Modified 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" Modified Report: 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	51	49
Overall Study COMPLETED	49	49
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Modified Reporting n=51 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" Modified Report: 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=49 Participants Microbiology laboratory will report identification and susceptibility results	Total n=100 Participants Total of all reporting groups
Age, Continuous	76.1 years STANDARD_DEVIATION 12.5 • n=51 Participants	74.0 years STANDARD_DEVIATION 17.7 • n=49 Participants	75.0 years STANDARD_DEVIATION 15.1 • n=100 Participants
Sex: Female, Male Female	34 Participants n=51 Participants	35 Participants n=49 Participants	69 Participants n=100 Participants
Sex: Female, Male Male	17 Participants n=51 Participants	14 Participants n=49 Participants	31 Participants n=100 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Canada	51 Participants n=51 Participants	49 Participants n=49 Participants	100 Participants n=100 Participants
Urinary Tract Infection	19 Participants n=51 Participants	19 Participants n=49 Participants	38 Participants n=100 Participants
Asymptomatic Bacteriuria	32 Participants n=51 Participants	30 Participants n=49 Participants	62 Participants n=100 Participants

PRIMARY outcome

Timeframe: 7 days

Number of Participants Who Received Appropriate Antibiotic Treatment

Outcome measures

Measure	Modified Reporting n=51 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" Modified Report: 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=49 Participants Microbiology laboratory will report identification and susceptibility results
Proportion of Asymptomatic Bacteriuria Treated With Antibiotics and Urinary Tract Infection Treated With Antibiotics	31 Participants	25 Participants

Adverse Events

Modified Reporting

Serious events: 0 serious events

Other events: 34 other events

Deaths: 2 deaths

Standard Reporting

Serious events: 1 serious events

Other events: 27 other events

Deaths: 0 deaths

Serious adverse events

Measure	Modified Reporting n=51 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" Modified Report: 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=49 participants at risk Microbiology laboratory will report identification and susceptibility results
Infections and infestations Bacteremia	0.00% 0/51 • 30 days Bacteremia during the trial was considered a serious adverse event	2.0% 1/49 • Number of events 1 • 30 days Bacteremia during the trial was considered a serious adverse event

Other adverse events

Measure	Modified Reporting n=51 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" Modified Report: 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=49 participants at risk Microbiology laboratory will report identification and susceptibility results
Cardiac disorders Tachycardia	27.5% 14/51 • Number of events 14 • 30 days Bacteremia during the trial was considered a serious adverse event	16.3% 8/49 • Number of events 8 • 30 days Bacteremia during the trial was considered a serious adverse event
Investigations Abnormal Temperature	15.7% 8/51 • Number of events 8 • 30 days Bacteremia during the trial was considered a serious adverse event	10.2% 5/49 • Number of events 5 • 30 days Bacteremia during the trial was considered a serious adverse event
Endocrine disorders Hyperglycemia	0.00% 0/51 • 30 days Bacteremia during the trial was considered a serious adverse event	2.0% 1/49 • Number of events 1 • 30 days Bacteremia during the trial was considered a serious adverse event
Skin and subcutaneous tissue disorders Edema	2.0% 1/51 • Number of events 1 • 30 days Bacteremia during the trial was considered a serious adverse event	0.00% 0/49 • 30 days Bacteremia during the trial was considered a serious adverse event
Blood and lymphatic system disorders Elevated White Blood Cell Count	5.9% 3/51 • Number of events 3 • 30 days Bacteremia during the trial was considered a serious adverse event	8.2% 4/49 • Number of events 4 • 30 days Bacteremia during the trial was considered a serious adverse event
Nervous system disorders Altered Mental Status	9.8% 5/51 • Number of events 5 • 30 days Bacteremia during the trial was considered a serious adverse event	8.2% 4/49 • Number of events 4 • 30 days Bacteremia during the trial was considered a serious adverse event
Respiratory, thoracic and mediastinal disorders Tachypnea	5.9% 3/51 • Number of events 3 • 30 days Bacteremia during the trial was considered a serious adverse event	10.2% 5/49 • Number of events 5 • 30 days Bacteremia during the trial was considered a serious adverse event

Additional Information

Peter Daley MD MSc

Memorial University

Phone: 7097772089

Email: pkd336@mun.ca

Results disclosure agreements

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