Trial Outcomes & Findings for Effects of Antibiotic Prophylaxis on Recurrent UTI in Children (NCT NCT02357758)

Results Overview

Changes to the urinary microbiota were measured as changes in the colony forming units (CFUs) of Enterococcus sp., Escherichia coli, Klebsiella sp./Enterobacter sp., Staphylococcus saprophyticus, or Pseudomonas sp./Staphylococcus aureus when the participant urine was cultured on CHROMagar Orientation. The data was analyzed in terms of bacterial counts, presence/absence, and presence at or above the diagnostic threshold for UTI (10\^5 CFU/mL of one species). Here we present participant midstream urine samples that met the diagnostic threshold for UTI at baseline.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

59 participants

Primary outcome timeframe

Baseline, 3-, 6-, 9-, 12-months

Results posted on

2021-09-21

Participant Flow

Participant milestones

Participant milestones
Measure	Antibiotic Prophylaxis Patients with RUTI receiving Septra (Trimethoprim dose 2mg/kg) or nitrofurantoin (dose 2 mg/kg) as determined by clinician. Antibiotic Prophylaxis	Healthy Population	Clinical Observation Patients experiencing RUTI that do not require antibiotic prophylaxis as determined by clinician.
Overall Study STARTED	25	20	12
Overall Study COMPLETED	9	20	5
Overall Study NOT COMPLETED	16	0	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of Antibiotic Prophylaxis on Recurrent UTI in Children

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Antibiotic Prophylaxis n=25 Participants Patients with RUTI receiving Septra (Trimethoprim dose 2mg/kg) or nitrofurantoin (dose 2 mg/kg) as determined by clinician. Antibiotic Prophylaxis	Healthy Population n=20 Participants	Clinical Observation n=12 Participants Patients experiencing RUTI that do not require antibiotic prophylaxis as determined by clinician.	Total n=57 Participants Total of all reporting groups
Age, Categorical <=18 years	25 Participants n=5 Participants	20 Participants n=7 Participants	12 Participants n=5 Participants	57 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	20 Participants n=7 Participants	12 Participants n=5 Participants	57 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment Canada	25 participants n=5 Participants	20 participants n=7 Participants	12 participants n=5 Participants	57 participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline, 3-, 6-, 9-, 12-months

Population: Bacterial culture data was not available for all participants due to the low volume of some samples.

Changes to the urinary microbiota were measured as changes in the colony forming units (CFUs) of Enterococcus sp., Escherichia coli, Klebsiella sp./Enterobacter sp., Staphylococcus saprophyticus, or Pseudomonas sp./Staphylococcus aureus when the participant urine was cultured on CHROMagar Orientation. The data was analyzed in terms of bacterial counts, presence/absence, and presence at or above the diagnostic threshold for UTI (10\^5 CFU/mL of one species). Here we present participant midstream urine samples that met the diagnostic threshold for UTI at baseline.

Outcome measures

Outcome measures
Measure	Antibiotic Prophylaxis n=17 Participants Patients with RUTI receiving Septra (Trimethoprim dose 2mg/kg) or nitrofurantoin (dose 2 mg/kg) as determined by clinician. Antibiotic Prophylaxis	Healthy Population n=19 Participants Patients with no history of RUTI or recent antibiotic usage.	Clinical Observation n=10 Participants Patients experiencing RUTI that do not require antibiotic prophylaxis as determined by clinician.
Changes to the Urinary Microbiota	3 participants	2 participants	1 participants

SECONDARY outcome

Timeframe: Baseline, 3-, 6-, 9- 12-months

Changes to metabolic profiles of urine as determined using gas chromatography mass spectrometry (GC-MS).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 3-, 6-, 9-, 12-months

Changes to antibiotic susceptibility of cultured bacteria as determined by the Kirby Bauer disc diffusion method.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 3-, 6-, 9-, 12-months

Changes in pro-inflammatory cytokines associated with inflammation and immune cell recruitment will be measured using multiplexed immunoassay kits employing Luminex® xMAP fluorescent beadbased technology.

Outcome measures

Outcome data not reported

Adverse Events

Antibiotic Prophylaxis

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Healthy Population

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Clinical Observation

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

Dr. Sumit Dave

London Health Sciences Centre

Phone: 519.685.8439

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place