Trial Outcomes & Findings for Modified Reporting From Indwelling Catheters (NCT NCT03488355)
NCT ID: NCT03488355
Last Updated: 2023-01-25
Results Overview
Untreated catheter-associated asymptomatic bacteriurias, plus treated catheter-associated urinary tract infections, divided by total patients.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
100 participants
Primary outcome timeframe
7 days after positive urine culture
Results posted on
2023-01-25
Participant Flow
Participant milestones
| Measure |
Modified Reporting
Modified laboratory report
Modified laboratory report: Report from microbiology laboratory: "This POSITIVE urine culture collected from an indwelling catheter may represent asymptomatic bacteriuria or urinary tract infection. If urinary tract infection is suspected clinically, please call the microbiology laboratory for identification and susceptibility results."
This intervention is not a drug or device, but a method of reporting of a laboratory report.
|
Standard Reporting
Standard laboratory report
|
|---|---|---|
|
Overall Study
STARTED
|
54
|
46
|
|
Overall Study
COMPLETED
|
54
|
46
|
|
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 |
Modified Reporting
n=54 Participants
Modified laboratory report
Modified laboratory report: Report from microbiology laboratory: "This POSITIVE urine culture collected from an indwelling catheter may represent asymptomatic bacteriuria or urinary tract infection. If urinary tract infection is suspected clinically, please call the microbiology laboratory for identification and susceptibility results."
|
Standard Reporting
n=46 Participants
Standard laboratory report
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70.8 years
STANDARD_DEVIATION 12.6 • n=54 Participants
|
73.3 years
STANDARD_DEVIATION 13.7 • n=46 Participants
|
72.0 years
STANDARD_DEVIATION 13.1 • n=100 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=54 Participants
|
18 Participants
n=46 Participants
|
46 Participants
n=100 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=54 Participants
|
28 Participants
n=46 Participants
|
54 Participants
n=100 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Canada
|
54 participants
n=54 Participants
|
46 participants
n=46 Participants
|
100 participants
n=100 Participants
|
PRIMARY outcome
Timeframe: 7 days after positive urine cultureUntreated catheter-associated asymptomatic bacteriurias, plus treated catheter-associated urinary tract infections, divided by total patients.
Outcome measures
| Measure |
Modified Reporting
n=54 Participants
Modified laboratory report
Modified laboratory report: Report from microbiology laboratory: "This POSITIVE urine culture collected from an indwelling catheter may represent asymptomatic bacteriuria or urinary tract infection. If urinary tract infection is suspected clinically, please call the microbiology laboratory for identification and susceptibility results."
|
Standard Reporting
n=46 Participants
Standard laboratory report
|
|---|---|---|
|
Number of Participants With Appropriate Treatment
|
31 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: 7 daysAll-cause mortality
Outcome measures
| Measure |
Modified Reporting
n=54 Participants
Modified laboratory report
Modified laboratory report: Report from microbiology laboratory: "This POSITIVE urine culture collected from an indwelling catheter may represent asymptomatic bacteriuria or urinary tract infection. If urinary tract infection is suspected clinically, please call the microbiology laboratory for identification and susceptibility results."
|
Standard Reporting
n=46 Participants
Standard laboratory report
|
|---|---|---|
|
Death
|
4 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 7 days after positive urine cultureNumber of participants with adverse events.
Outcome measures
| Measure |
Modified Reporting
n=54 Participants
Modified laboratory report
Modified laboratory report: Report from microbiology laboratory: "This POSITIVE urine culture collected from an indwelling catheter may represent asymptomatic bacteriuria or urinary tract infection. If urinary tract infection is suspected clinically, please call the microbiology laboratory for identification and susceptibility results."
|
Standard Reporting
n=46 Participants
Standard laboratory report
|
|---|---|---|
|
Adverse Events
|
13 Participants
|
19 Participants
|
Adverse Events
Modified Reporting
Serious events: 3 serious events
Other events: 13 other events
Deaths: 4 deaths
Standard Reporting
Serious events: 0 serious events
Other events: 19 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Modified Reporting
n=54 participants at risk
Modified laboratory report
Modified laboratory report: Report from microbiology laboratory: "This POSITIVE urine culture collected from an indwelling catheter may represent asymptomatic bacteriuria or urinary tract infection. If urinary tract infection is suspected clinically, please call the microbiology laboratory for identification and susceptibility results."
|
Standard Reporting
n=46 participants at risk
Standard laboratory report
|
|---|---|---|
|
Infections and infestations
Bacteremia
|
5.6%
3/54 • Number of events 3 • Seven days
Number of patients with adverse event
|
0.00%
0/46 • Seven days
Number of patients with adverse event
|
Other adverse events
| Measure |
Modified Reporting
n=54 participants at risk
Modified laboratory report
Modified laboratory report: Report from microbiology laboratory: "This POSITIVE urine culture collected from an indwelling catheter may represent asymptomatic bacteriuria or urinary tract infection. If urinary tract infection is suspected clinically, please call the microbiology laboratory for identification and susceptibility results."
|
Standard Reporting
n=46 participants at risk
Standard laboratory report
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
1.9%
1/54 • Number of events 1 • Seven days
Number of patients with adverse event
|
0.00%
0/46 • Seven days
Number of patients with adverse event
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/54 • Seven days
Number of patients with adverse event
|
2.2%
1/46 • Number of events 1 • Seven days
Number of patients with adverse event
|
|
Renal and urinary disorders
Acute Kidney Injury
|
1.9%
1/54 • Number of events 1 • Seven days
Number of patients with adverse event
|
0.00%
0/46 • Seven days
Number of patients with adverse event
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/54 • Seven days
Number of patients with adverse event
|
2.2%
1/46 • Number of events 1 • Seven days
Number of patients with adverse event
|
|
Psychiatric disorders
Auditory Hallucinations
|
0.00%
0/54 • Seven days
Number of patients with adverse event
|
2.2%
1/46 • Number of events 1 • Seven days
Number of patients with adverse event
|
|
Infections and infestations
Candidemia
|
0.00%
0/54 • Seven days
Number of patients with adverse event
|
2.2%
1/46 • Number of events 1 • Seven days
Number of patients with adverse event
|
|
General disorders
Chest Pain
|
1.9%
1/54 • Number of events 1 • Seven days
Number of patients with adverse event
|
0.00%
0/46 • Seven days
Number of patients with adverse event
|
|
Nervous system disorders
Confusion
|
1.9%
1/54 • Number of events 1 • Seven days
Number of patients with adverse event
|
4.3%
2/46 • Number of events 2 • Seven days
Number of patients with adverse event
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/54 • Seven days
Number of patients with adverse event
|
4.3%
2/46 • Number of events 2 • Seven days
Number of patients with adverse event
|
|
Nervous system disorders
Decreased level of consciousness
|
0.00%
0/54 • Seven days
Number of patients with adverse event
|
2.2%
1/46 • Number of events 1 • Seven days
Number of patients with adverse event
|
|
Blood and lymphatic system disorders
Decreased white blood cell count
|
0.00%
0/54 • Seven days
Number of patients with adverse event
|
2.2%
1/46 • Number of events 1 • Seven days
Number of patients with adverse event
|
|
Nervous system disorders
Dizziness
|
0.00%
0/54 • Seven days
Number of patients with adverse event
|
2.2%
1/46 • Number of events 1 • Seven days
Number of patients with adverse event
|
|
General disorders
Edema
|
0.00%
0/54 • Seven days
Number of patients with adverse event
|
2.2%
1/46 • Number of events 1 • Seven days
Number of patients with adverse event
|
|
General disorders
Fall
|
0.00%
0/54 • Seven days
Number of patients with adverse event
|
2.2%
1/46 • Number of events 1 • Seven days
Number of patients with adverse event
|
|
General disorders
Fever
|
1.9%
1/54 • Number of events 1 • Seven days
Number of patients with adverse event
|
0.00%
0/46 • Seven days
Number of patients with adverse event
|
|
General disorders
Fluid Overload
|
0.00%
0/54 • Seven days
Number of patients with adverse event
|
2.2%
1/46 • Number of events 1 • Seven days
Number of patients with adverse event
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/54 • Seven days
Number of patients with adverse event
|
2.2%
1/46 • Number of events 1 • Seven days
Number of patients with adverse event
|
|
Renal and urinary disorders
Hypokalemia
|
1.9%
1/54 • Number of events 1 • Seven days
Number of patients with adverse event
|
2.2%
1/46 • Number of events 1 • Seven days
Number of patients with adverse event
|
|
General disorders
Increased liver enzymes
|
0.00%
0/54 • Seven days
Number of patients with adverse event
|
2.2%
1/46 • Number of events 1 • Seven days
Number of patients with adverse event
|
|
Reproductive system and breast disorders
Penis discharge
|
0.00%
0/54 • Seven days
Number of patients with adverse event
|
2.2%
1/46 • Number of events 1 • Seven days
Number of patients with adverse event
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory secretions
|
1.9%
1/54 • Number of events 1 • Seven days
Number of patients with adverse event
|
0.00%
0/46 • Seven days
Number of patients with adverse event
|
|
Skin and subcutaneous tissue disorders
Skin tear
|
1.9%
1/54 • Number of events 1 • Seven days
Number of patients with adverse event
|
0.00%
0/46 • Seven days
Number of patients with adverse event
|
|
General disorders
Shortness of breath
|
1.9%
1/54 • Number of events 1 • Seven days
Number of patients with adverse event
|
2.2%
1/46 • Number of events 1 • Seven days
Number of patients with adverse event
|
|
Psychiatric disorders
Suicidality
|
1.9%
1/54 • Number of events 1 • Seven days
Number of patients with adverse event
|
0.00%
0/46 • Seven days
Number of patients with adverse event
|
|
General disorders
Suprapubic tenderness
|
1.9%
1/54 • Number of events 1 • Seven days
Number of patients with adverse event
|
0.00%
0/46 • Seven days
Number of patients with adverse event
|
|
Infections and infestations
Wound infection
|
1.9%
1/54 • Number of events 1 • Seven days
Number of patients with adverse event
|
0.00%
0/46 • Seven days
Number of patients with adverse event
|
|
Cardiac disorders
Tachycardia
|
1.9%
1/54 • Number of events 1 • Seven days
Number of patients with adverse event
|
0.00%
0/46 • Seven days
Number of patients with adverse event
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place