NCT03275623

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 5, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 7, 2017

Completed
8 days until next milestone

Study Start

First participant enrolled

September 15, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 18, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 18, 2019

Completed
1 year until next milestone

Results Posted

Study results publicly available

April 3, 2020

Completed
Last Updated

April 3, 2020

Status Verified

March 1, 2020

Enrollment Period

1.5 years

First QC Date

September 5, 2017

Results QC Date

March 19, 2020

Last Update Submit

March 19, 2020

Conditions

CystitisCystitis;PuerperiumPyelonephritis

Outcome Measures

Primary Outcomes (2)

  • Number of Participants Who Have Cystitis

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

    about 10 months

  • Number of Participants Who Have Pyelonephritis

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

    about 10 months

Study Arms (2)

Antibiotic treatment

ACTIVE COMPARATOR

Standard prenatal care with treatment for any urine culture with growth of 1- 100,000 CFU of any organism.

Drug: AntibioticOther: Standard Prenatal Care

No antibiotic treatment

ACTIVE COMPARATOR

Standard prenatal care without treatment for any urine culture with growth of 1- 100,000 CFU of any organism.

Other: Standard Prenatal Care

Interventions

AntibioticDRUG

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.

Antibiotic treatment
Standard Prenatal CareOTHER

Continued surveillance of urinary cultures

Antibiotic treatmentNo antibiotic treatment

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnant women who seek prenatal care within the University of Texas Health System with UT Physicians.
  • Urine culture of less than 100,000 CFU

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

CystitisPyelonephritis

Interventions

Anti-Bacterial Agents

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesNephritis, InterstitialNephritisKidney DiseasesPyelitis

Intervention Hierarchy (Ancestors)

Anti-Infective AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Results Point of Contact

Title
Jerrie S. Refuerzo, MD
Organization
The University of Texas Health Science Center at Houston
Jerrie.S.Refuerzo@uth.tmc.edu
(713) 500-6416

Study Officials

  • Akwugo A Eziefule, MD

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Physician

Study Record Dates

First Submitted

September 5, 2017

First Posted

September 7, 2017

Study Start

September 15, 2017

Primary Completion

March 18, 2019

Study Completion

March 18, 2019

Last Updated

April 3, 2020

Results First Posted

April 3, 2020

Record last verified: 2020-03

Locations

US(1)