NCT02911662

Brief Summary

This is a prospective randomized controlled day comparing the efficacy of three-day antimicrobial treatment of asymptomatic bacteriuria (ASB) in pregnancy to the standard seven-day treatment. Half the patients will receive 3-day treatment and the other half will receive 7 days of antibiotics.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2016

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

September 15, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 22, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

April 18, 2018

Status Verified

April 1, 2018

Enrollment Period

1.3 years

First QC Date

September 15, 2016

Last Update Submit

April 16, 2018

Conditions

Bacteriuria (Asymptomatic) in Pregnancy

Outcome Measures

Primary Outcomes (1)

  • Evidence that 3-day treatment is as effective as 7-day treatment of asymptomatic bacteriuria in pregnancy.

    Comparison of percentage of women in each group with successful treatment or asymptomatic bacteriuria with negative urine culture 2 weeks after randomized treatment.

    Within 21 days of treatment

Secondary Outcomes (3)

  • Comparison of development of cystitis during pregnancy.

    Until 6 weeks postpartum

  • The occurence of preterm delivery

    Assessed at the time of delivery

  • Comparison of development of pyelonephritis during pregnancy

    Until 6 weeks postpartum

Study Arms (2)

3-day treatment

EXPERIMENTAL

Three-day treatment with Cephalexin or Nitrofurantoin for diagnosis of asymptomatic bacteriuria in pregnancy.

Drug: CephalexinDrug: Nitrofurantoin

7-day treatment

ACTIVE COMPARATOR

Seven-day treatment with Cephalexin or Nitrofurantoin for diagnosis of asymptomatic bacteriuria in pregnancy.

Drug: CephalexinDrug: Nitrofurantoin

Interventions

CephalexinDRUG

Cephalexin will be prescribed for women with a positive urine culture but no symptoms of urinary tract infection.

Also known as: Keflex
3-day treatment7-day treatment
NitrofurantoinDRUG

Macrobid will be prescribed for women allergic to penicillin with a positive urine culture but no symptoms of urinary tract infection.

Also known as: Macrobid
3-day treatment7-day treatment

Eligibility Criteria

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

You may qualify if:

  • Pregnant women ≥ 18 years of age seeking prenatal care at the Academic Obstetrics and Gynecology Center at St. Joseph Mercy Hospital, Ann Arbor, Michigan
  • Randomization will occur if the patient every has a urine culture demonstrating ≥10,000 cfu/ml of a pathogenic urinary tract organism

You may not qualify if:

  • Symptomatic bacteriuria (cystitis or pyelonephritis) at the time of urine collection
  • Previously treated bacteriuria in current pregnancy
  • Past medical history of known congenital or acquired urinary tract anomaly or abnormality (i.e. pelvic kidney, single kidney, renal transplant)
  • Any antibiotic use within the week prior to urine sampling
  • Urine culture revealing growth of the following organisms: Lactobacillus, coagulase-negative staphylococcus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Joseph Mercy Hospital

Ypsilanti, Michigan, 48197, United States

Location

Related Publications (3)

  • Widmer M, Lopez I, Gulmezoglu AM, Mignini L, Roganti A. Duration of treatment for asymptomatic bacteriuria during pregnancy. Cochrane Database Syst Rev. 2015 Nov 11;2015(11):CD000491. doi: 10.1002/14651858.CD000491.pub3.

    PMID: 26560337BACKGROUND

  • Patterson TF, Andriole VT. Detection, significance, and therapy of bacteriuria in pregnancy. Update in the managed health care era. Infect Dis Clin North Am. 1997 Sep;11(3):593-608. doi: 10.1016/s0891-5520(05)70375-5.

    PMID: 9378925BACKGROUND

  • Romero R, Oyarzun E, Mazor M, Sirtori M, Hobbins JC, Bracken M. Meta-analysis of the relationship between asymptomatic bacteriuria and preterm delivery/low birth weight. Obstet Gynecol. 1989 Apr;73(4):576-82.

    PMID: 2927852BACKGROUND

MeSH Terms

Conditions

Bacteriuria

Interventions

CephalexinNitrofurantoin

Condition Hierarchy (Ancestors)

Urinary Tract InfectionsInfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cephalosporinsbeta-LactamsLactamsAmidesOrganic ChemicalsThiazinesSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNitrofuransNitro CompoundsFuransHeterocyclic Compounds, 1-Ring

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Obstetrical Research

Study Record Dates

First Submitted

September 15, 2016

First Posted

September 22, 2016

Study Start

September 1, 2016

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

April 18, 2018

Record last verified: 2018-04

Locations

US(1)