An interventional study of Cephalexin and Nitrofurantoin in Bacteriuria (Asymptomatic) in Pregnancy, sponsored by Saint Joseph Mercy Health System. Terminated at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-04-18.
Sponsored by Saint Joseph Mercy Health System · Not applicable, Interventional, and Treatment
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.
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.
51 studies on the registry are indexed under Bacteriuria; 3 are open to participants now.
This study's enrollment of 13 is below the median of 100 across 37 interventional studies indexed under Bacteriuria.
Browse Bacteriuria studies →Saint Joseph Mercy Health System is the lead sponsor of 6 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Three-day treatment with Cephalexin or Nitrofurantoin for diagnosis of asymptomatic bacteriuria in pregnancy.
Drug: Cephalexin · Drug: Nitrofurantoin
Seven-day treatment with Cephalexin or Nitrofurantoin for diagnosis of asymptomatic bacteriuria in pregnancy.
Drug: Cephalexin · Drug: Nitrofurantoin
Cephalexin will be prescribed for women with a positive urine culture but no symptoms of urinary tract infection.
Also known as: Keflex
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
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.
Time frame: Within 21 days of treatment
Comparison of development of cystitis during pregnancy.
Comparison of percentage of women in each group who develop cystitis during pregnancy and the postpartum period.
Time frame: Until 6 weeks postpartum
The occurence of preterm delivery
Comparison of the percentage of women in each group who deliver at \<37 weeks gestation.
Time frame: Assessed at the time of delivery
Comparison of development of pyelonephritis during pregnancy
Comparison of percentage of women in each group who develop pyelonephritis during pregnancy and the postpartum period.
Time frame: Until 6 weeks postpartum
This study is terminated, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Cephalexin · Nitrofurantoin
Saint Joseph Mercy Health System