Trial Outcomes & Findings for Efficacy of Micro-Patterned Foley Catheter to Reduce Catheter-Associated Urinary Tract Infection (NCT NCT02198833)

Results Overview

Patients will be assessed daily for the occurrence of signs and symptoms of urinary tract infection. A single, independent evaluator (PI/co-investigator) will determine whether the subject has a catheter associated urinary tract infection based on pre-defined criteria that involve symptom reports and lab values without knowledge of or access to the catheter type randomly assigned to the patient.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

2 participants

Primary outcome timeframe

15 Days

Results posted on

2017-04-07

Participant Flow

Participant milestones

Participant milestones
Measure	Micro-Patterned Foley Catheter Procedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy Urine Culture: Obtain urine culture every third day Foley Catheter Tip Culture: Catheter Tip Roll Plate Culture Scanning Electron Microscopy: Houston Site Only Device Specific Adverse Event Assessment: Assessment will be made of catheter patency and/or trauma related to catheter placement Foley Catheter Insertion: Insert Foley catheter for 15 day duration	Standard-of-Care Foley Catheter Procedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy Urine Culture: Obtain urine culture every third day Foley Catheter Tip Culture: Catheter Tip Roll Plate Culture Scanning Electron Microscopy: Houston Site Only Device Specific Adverse Event Assessment: Assessment will be made of catheter patency and/or trauma related to catheter placement Foley Catheter Insertion: Insert Foley catheter for 15 day duration
Overall Study STARTED	1	1
Overall Study COMPLETED	1	1
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy of Micro-Patterned Foley Catheter to Reduce Catheter-Associated Urinary Tract Infection

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Micro-Patterned Foley Catheter Procedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy Urine Culture: Obtain urine culture every third day Foley Catheter Tip Culture: Catheter Tip Roll Plate Culture Scanning Electron Microscopy: Houston Site Only Device Specific Adverse Event Assessment: Assessment will be made of catheter patency and/or trauma related to catheter placement Foley Catheter Insertion: Insert Foley catheter for 15 day duration	Standard-of-Care Foley Catheter Procedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy Urine Culture: Obtain urine culture every third day Foley Catheter Tip Culture: Catheter Tip Roll Plate Culture Scanning Electron Microscopy: Houston Site Only Device Specific Adverse Event Assessment: Assessment will be made of catheter patency and/or trauma related to catheter placement Foley Catheter Insertion: Insert Foley catheter for 15 day duration	Total Total of all reporting groups
Age, Categorical <=18 years	—	—	0 n=206 Participants
Age, Categorical Between 18 and 65 years	—	—	0 n=206 Participants
Age, Categorical >=65 years	—	—	0 n=206 Participants
Sex: Female, Male Female	—	—	0 n=206 Participants
Sex: Female, Male Male	—	—	0 n=206 Participants

PRIMARY outcome

Timeframe: 15 Days

Population: No analysis completed due to inability to place study catheter due to persistent bacterial colonization.

Patients will be assessed daily for the occurrence of signs and symptoms of urinary tract infection. A single, independent evaluator (PI/co-investigator) will determine whether the subject has a catheter associated urinary tract infection based on pre-defined criteria that involve symptom reports and lab values without knowledge of or access to the catheter type randomly assigned to the patient.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 15 days

Population: No analysis completed. Study catheter placed in only 2 patients due to inability to clear bacterial from urinary bladder during screening.

Urine cultures will be obtained every third day to assess for the presence of microbial growth.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 15 or upon removal of Foley Catheter

Population: No analysis completed. Study catheter placed in only 2 patients due to inability to clear bacterial from urinary bladder during screening.

Catheters will be cultured by Roll-plate method for microbial growth. Catheters removed at the Houston site will also be evaluated by scanning electron microscopy to determine microbial coverage and biofilm formation.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 15 Days

Population: No analysis completed. Study catheter placed in only 2 patients due to inability to clear bacterial from urinary bladder during screening.

Patient will be assessed daily for signs and symptoms of infection. Catheter placement and patency will be confirmed. Insertion site will be evaluated for signs of inflammation and or trauma.

Outcome measures

Outcome data not reported

Adverse Events

Micro-Patterned Foley Catheter

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard-of-Care Foley Catheter

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Rabih Darouiche, MD

Baylor College of Medcine

Phone: 713-794-8858

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place