Clinical trial NCT02911662: Treatment of Asymptomatic Bacteriuria in Pregnancy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Bacteriuria (Asymptomatic) in Pregnancy
Lead sponsor: Saint Joseph Mercy Health System
Sponsor class: OTHER
First posted: 2016-09-22
Enrollment: 13
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: The current standard of practice is to treat pregnant patients with ASB with a 7-day course of oral antimicrobial agents. If bacteriuria persists women are retreated with the same of different agent for a second course of 7 to 14 days and they may be subsequently placed on prophylaxis.

In nonpregnant women, an uncomplicated lower urinary tract infection may be treated with a short course regimen from 1 to 3 days. This approach has similar rates of persistent bacteriuria or symptoms following treatment when compared to women treated with a more conventional approach. If the infection recurs or persists, the patient may then be treated with the more traditional 7 to 14 day course. The advantages of single-dose regimens are cost and patient compliance, but a major disadvantage is the failure to eradicate uropathogens from the vaginal reservoir, which results in more frequent early recurrences.

The three-day regimen is advocated to maintain the advantages of lower costs and patient compliance but improving cure rates. Multiple studies have shown the advantage of even a short course of antibiotics as opposed to no treatment.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Evidence that 3-day treatment is as effective as 7-day treatment of asymptomatic bacteriuria in pregnancy.
timeFrame: Within 21 days of treatment
Secondary outcomes:
measure: Comparison of development of cystitis during pregnancy.
timeFrame: Until 6 weeks postpartum
measure: The occurence of preterm delivery
timeFrame: Assessed at the time of delivery
measure: Comparison of development of pyelonephritis during pregnancy
timeFrame: Until 6 weeks postpartum
Other outcomes:
Locations:
city: Ypsilanti
country: United States
facility: St. Joseph Mercy Hospital
state: Michigan
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.