Management of Sub-Clinical Bacteriuria in Pregnancy

• Sponsor: The University of Texas Health Science Center, Houston (Other)
• Overall Status: Completed
• CT.gov ID: NCT03275623
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Actual Duration (Months): 18
• Patients Per Site Per Month: 3.3

Study Details

Study Description

Brief Summary

The purpose of the study is to determine if treatment of pregnant women with urine cultures with a low level of bacteria (less than 100,000 colony forming units (CFU)) may decrease adverse pregnancy outcomes.

Condition or Disease	Intervention/Treatment	Phase
Cystitis; Cystitis;Puerperium; Pyelonephritis	Drug: Antibiotic; Other: Standard Prenatal Care	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Management of Sub-Clinical Bacteriuria in Pregnancy: A Feasibility Trial
• Actual Study Start Date: Sep 15, 2017
• Actual Primary Completion Date: Mar 18, 2019
• Actual Study Completion Date: Mar 18, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Antibiotic treatment Standard prenatal care with treatment for any urine culture with growth of 1- 100,000 CFU of any organism.	Drug: Antibiotic; Those randomized for treatment will be prescribed the most commonly used antibiotic for urinary tract infections in pregnancy. This includes: Nitrofurantoin, Cephalexin, and Amoxicillin. It is unsure which antibiotic the participant will receive but a majority of the time it will be one of the above named antibiotic. The choice will be determined by the physician, but will accommodate participants' prior medication history and adverse events.; Other: Standard Prenatal Care; Continued surveillance of urinary cultures
Active Comparator: No antibiotic treatment Standard prenatal care without treatment for any urine culture with growth of 1- 100,000 CFU of any organism.	Other: Standard Prenatal Care; Continued surveillance of urinary cultures

Outcome Measures

Primary Outcome Measures

1. Number of Participants Who Have Cystitis [about 10 months]

   Cystitis is defined as a urine culture with >100,000 CFU at any point during antenatal care.

2. Number of Participants Who Have Pyelonephritis [about 10 months]

   Pyelonephritis is defined as a urine culture with >100,000 CFU with fever at any point during antenatal care.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Pregnant women who seek prenatal care within the University of Texas Health System with UT Physicians.

• Urine culture of less than 100,000 CFU

Exclusion Criteria:

• Less than 18 years of age

• Risk factors to complicated UTI (including but not limited to: diverticula, urolithiasis, renal cysts, indwelling catheter, intermittent catheterization, stent placements, nephrostomy tubes, neurogenic bladder, cystocele, vesicoureteral reflux, ileal conduit)

• Use of immunosuppressant drugs

• Abnormalities of the urinary tract (including but not limited to: known ureteric or urethral strictures, tumors of the urinary tract, pelvicalyceal obstruction, congenital anomalies, history of urological procedures)

• History of renal disease including renal failure and transplants

• Urine culture > 100,000 CFU of any organism

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Texas Health Science Center at Houston	Houston	Texas	United States	77030

Sponsors and Collaborators

• The University of Texas Health Science Center, Houston

Investigators

• Principal Investigator: Akwugo A Eziefule, MD, The University of Texas Health Science Center, Houston

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 22, 2017

More Information

Publications

None provided.

• Responsible Party: Akwugo Adanna Eziefule, Staff Physician, The University of Texas Health Science Center, Houston
• ClinicalTrials.gov Identifier: NCT03275623
• Other Study ID Numbers: HSC-MS-17-0294
• First Posted: Sep 7, 2017
• Last Update Posted: Apr 3, 2020
• Last Verified: Mar 1, 2020

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Bacteriuria; Cystitis; Pyelonephritis; Anti-Bacterial Agents

Study Results

Participant Flow

Arm/Group Title	Antibiotic Treatment	No Antibiotic Treatment
Arm/Group Description	Standard prenatal care with treatment for any urine culture with growth of 1- 100,000 CFU of any organism. Antibiotic: Those randomized for treatment will be prescribed the most commonly used antibiotic for urinary tract infections in pregnancy. This includes: Nitrofurantoin, Cephalexin, and Amoxicillin. It is unsure which antibiotic the participant will receive but a majority of the time it will be one of the above named antibiotic. The choice will be determined by the physician, but will accommodate participants' prior medication history and adverse events. Standard Prenatal Care: Continued surveillance of urinary cultures	Standard prenatal care without treatment for any urine culture with growth of 1- 100,000 CFU of any organism. Standard Prenatal Care: Continued surveillance of urinary cultures
Period Title: Overall Study
STARTED	30	30
COMPLETED	25	28
NOT COMPLETED	5	2

Baseline Characteristics

Arm/Group Title	No Antibiotic Treatment	Antibiotic Treatment	Total
Arm/Group Description	Standard prenatal care without treatment for any urine culture with growth of 1- 100,000 CFU of any organism. Standard Prenatal Care: Continued surveillance of urinary cultures	Standard prenatal care with treatment for any urine culture with growth of 1- 100,000 CFU of any organism. Antibiotic: Those randomized for treatment will be prescribed the most commonly used antibiotic for urinary tract infections in pregnancy. This includes: Nitrofurantoin, Cephalexin, and Amoxicillin. It is unsure which antibiotic the participant will receive but a majority of the time it will be one of the above named antibiotic. The choice will be determined by the physician, but will accommodate participants' prior medication history and adverse events. Standard Prenatal Care: Continued surveillance of urinary cultures	Total of all reporting groups
Overall Participants	30	30	60
Age, Customized (Count of Participants)
<20	6 20%	11 36.7%	17 28.3%
20-34	19 63.3%	12 40%	31 51.7%
>=35	5 16.7%	7 23.3%	12 20%
Sex: Female, Male (Count of Participants)
Female	30 100%	30 100%	60 100%
Male	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (Count of Participants)
Black	17 56.7%	15 50%	32 53.3%
Hispanic	4 13.3%	9 30%	13 21.7%
White	5 16.7%	4 13.3%	9 15%
Other	4 13.3%	2 6.7%	6 10%
Region of Enrollment (Count of Participants)
United States	30 100%	30 100%	60 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants Who Have Cystitis
Description	Cystitis is defined as a urine culture with >100,000 CFU at any point during antenatal care.
Time Frame	about 10 months

Outcome Measure Data

Analysis Population Description

2 participants in the "no antibiotic treatment" arm and 5 in the "antibiotic treatment" arm were not assessed for this outcome measure.

Arm/Group Title	No Antibiotic Treatment	Antibiotic Treatment
Arm/Group Description	Standard prenatal care without treatment for any urine culture with growth of 1- 100,000 CFU of any organism. Standard Prenatal Care: Continued surveillance of urinary cultures	Standard prenatal care with treatment for any urine culture with growth of 1- 100,000 CFU of any organism. Antibiotic: Those randomized for treatment will be prescribed the most commonly used antibiotic for urinary tract infections in pregnancy. This includes: Nitrofurantoin, Cephalexin, and Amoxicillin. It is unsure which antibiotic the participant will receive but a majority of the time it will be one of the above named antibiotic. The choice will be determined by the physician, but will accommodate participants' prior medication history and adverse events. Standard Prenatal Care: Continued surveillance of urinary cultures
Measure Participants	28	25
Count of Participants [Participants]	4 13.3%	4 13.3%

2. Primary Outcome

Title	Number of Participants Who Have Pyelonephritis
Description	Pyelonephritis is defined as a urine culture with >100,000 CFU with fever at any point during antenatal care.
Time Frame	about 10 months

Outcome Measure Data

Analysis Population Description

2 participants in the "no antibiotic treatment" arm and 5 in the "antibiotic treatment" arm were not assessed for this outcome measure.

Arm/Group Title	No Antibiotic Treatment	Antibiotic Treatment
Arm/Group Description	Standard prenatal care without treatment for any urine culture with growth of 1- 100,000 CFU of any organism. Standard Prenatal Care: Continued surveillance of urinary cultures	Standard prenatal care with treatment for any urine culture with growth of 1- 100,000 CFU of any organism. Antibiotic: Those randomized for treatment will be prescribed the most commonly used antibiotic for urinary tract infections in pregnancy. This includes: Nitrofurantoin, Cephalexin, and Amoxicillin. It is unsure which antibiotic the participant will receive but a majority of the time it will be one of the above named antibiotic. The choice will be determined by the physician, but will accommodate participants' prior medication history and adverse events. Standard Prenatal Care: Continued surveillance of urinary cultures
Measure Participants	28	25
Count of Participants [Participants]	3 10%	4 13.3%

Adverse Events

Time Frame	during antenatal care (about 10 months)
Arm/Group Title	No Antibiotic Treatment		Antibiotic Treatment
Arm/Group Description	Standard prenatal care without treatment for any urine culture with growth of 1- 100,000 CFU of any organism. Standard Prenatal Care: Continued surveillance of urinary cultures		Standard prenatal care with treatment for any urine culture with growth of 1- 100,000 CFU of any organism. Antibiotic: Those randomized for treatment will be prescribed the most commonly used antibiotic for urinary tract infections in pregnancy. This includes: Nitrofurantoin, Cephalexin, and Amoxicillin. It is unsure which antibiotic the participant will receive but a majority of the time it will be one of the above named antibiotic. The choice will be determined by the physician, but will accommodate participants' prior medication history and adverse events. Standard Prenatal Care: Continued surveillance of urinary cultures
All Cause Mortality
	No Antibiotic Treatment		Antibiotic Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/30 (0%)
Serious Adverse Events
	No Antibiotic Treatment		Antibiotic Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/30 (0%)
Other (Not Including Serious) Adverse Events
	No Antibiotic Treatment		Antibiotic Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/30 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.