Trial Outcomes & Findings for Antibiotic Use Following Distal and Mid-shaft Hypospadias Repair (NCT NCT02593903)

Results Overview

Urinary tract infection (UTI) will be diagnosed based on urine culture positive at 50,000CFUs per mL with one or both of the following: fever \>38 Celsius, or significant fussiness and irritability with voiding per parent report. Asymptomatic bacteriuria is known and expected in this population; therefore culture positive results alone will not be sufficient to meet the definition of UTI.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

67 participants

Primary outcome timeframe

4-8 days post-operation

Results posted on

2018-11-05

Participant Flow

Participant milestones

Participant milestones
Measure	Antibiotics Group Patients randomized to this arm will receive prophylactic oral antibiotics following the surgery and catheter placement (Septra, 3 mg/kg/dose once daily), and will continue the medication for until the day before catheter removal 4-8 days post-operation.	No Antibiotics Group Patients randomized to this arm will receive regular clinical care without prophylactic antibiotics, including catheter placement/removal.
Overall Study STARTED	35	32
Overall Study COMPLETED	35	31
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Antibiotics Group n=35 Participants Patients randomized to this arm will receive prophylactic oral antibiotics following the surgery and catheter placement (Septra, 3 mg/kg/dose once daily), and will continue the medication for until the day before catheter removal 4-8 days post-operation.	No Antibiotics Group n=32 Participants Patients randomized to this arm will receive regular clinical care without prophylactic antibiotics, including catheter placement/removal.	Total n=67 Participants Total of all reporting groups
Age, Categorical <=18 years	35 Participants n=35 Participants	32 Participants n=32 Participants	67 Participants n=67 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=35 Participants	0 Participants n=32 Participants	0 Participants n=67 Participants
Age, Categorical >=65 years	0 Participants n=35 Participants	0 Participants n=32 Participants	0 Participants n=67 Participants
Sex/Gender, Customized Male	35 Participants n=35 Participants	32 Participants n=32 Participants	67 Participants n=67 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 4-8 days post-operation

Population: Out of the consented and randomized participants these were the patients that we were able to obtain a post Op Urine sample

Urinary tract infection (UTI) will be diagnosed based on urine culture positive at 50,000CFUs per mL with one or both of the following: fever \>38 Celsius, or significant fussiness and irritability with voiding per parent report. Asymptomatic bacteriuria is known and expected in this population; therefore culture positive results alone will not be sufficient to meet the definition of UTI.

Outcome measures

Outcome measures
Measure	Antibiotics Group n=30 Participants Patients randomized to this arm will receive prophylactic oral antibiotics following the surgery and catheter placement (Septra, 3 mg/kg/dose once daily), and will continue the medication for until the day before catheter removal 4-8 days post-operation.	No Antibiotics Group n=22 Participants Patients randomized to this arm will receive regular clinical care without prophylactic antibiotics, including catheter placement/removal.
Number of Participants With Urinary Tract Infection Post Op Urine Sample obtained	30 Participants	22 Participants
Number of Participants With Urinary Tract Infection clinical UTI	0 Participants	0 Participants

Adverse Events

Antibiotics Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No Antibiotics Group

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

Clinical Research Coordinator

Medical College of Wisconsin

Phone: 414-337-3441

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place