Bacteriuria (Asymptomatic) in PregnancyNCT02911662
Treatment of Asymptomatic Bacteriuria in Pregnancy
A study testing Cephalexin and Nitrofurantoin in people with Bacteriuria (Asymptomatic) in Pregnancy, run by Trinity Health Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bacteriuria (Asymptomatic) in Pregnancy
- What is being tested?
- Cephalexin and Nitrofurantoin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Joseph Mercy Hospital
Ypsilanti, Michigan, 48197
About this study
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.
Read the 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.
- Conditions
- Bacteriuria (Asymptomatic) in Pregnancy
- Being tested
- Cephalexin, Nitrofurantoin
- Medical subject headings
- Bacteriuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CephalexinDrug
Also called Keflex
Cephalexin will be prescribed for women with a positive urine culture but no symptoms of urinary tract infection.
NitrofurantoinDrug
Also called Macrobid
Macrobid will be prescribed for women allergic to penicillin with a positive urine culture but no symptoms of urinary tract infection.
| Study group | Role | What they receive |
|---|---|---|
| 3-day treatment | Experimental | Three-day treatment with Cephalexin or Nitrofurantoin for diagnosis of asymptomatic bacteriuria in pregnancy. Receives: Drug: Cephalexin; Drug: Nitrofurantoin |
| 7-day treatment | Active comparator | Seven-day treatment with Cephalexin or Nitrofurantoin for diagnosis of asymptomatic bacteriuria in pregnancy. Receives: Drug: Cephalexin; Drug: Nitrofurantoin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 21 days of treatment
Secondary outcomes (3)
Comparison of development of cystitis during pregnancy.
Comparison of percentage of women in each group who develop cystitis during pregnancy and the postpartum period.
Measured: Until 6 weeks postpartum
The occurence of preterm delivery
Comparison of the percentage of women in each group who deliver at <37 weeks gestation.
Measured: 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.
Measured: Until 6 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionJan 2018
- Study completionJan 2018
Why it stopped: Inability to enroll patients at anticipated rate.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Bacteriuria (Asymptomatic) in PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trinity Health Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pooja Green, Trinity Health Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02911662
- Sponsor's protocol ID
- HSR-16-1661
- Status last verified
- Apr 2018
- First submitted
- 15 Sep 2016
- Last updated
- 18 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26560337Patterson 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.
PubMed 9378925Romero 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.
PubMed 2927852
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Asymptomatic Bacteriuria in Pregnancy
- ClinicalTrials.gov ID
- NCT02911662
- Acronym / sponsor ID
- HSR-16-1661
- Conditions
- Bacteriuria (Asymptomatic) in Pregnancy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inability to enroll patients at anticipated rate.
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Trinity Health MichiganUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 22 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3-day treatment | Experimental | Drug: Cephalexin, Drug: NitrofurantoinThree-day treatment with Cephalexin or Nitrofurantoin for diagnosis of asymptomatic bacteriuria in pregnancy. |
| 7-day treatment | Active comparator | Drug: Cephalexin, Drug: NitrofurantoinSeven-day treatment with Cephalexin or Nitrofurantoin for diagnosis of asymptomatic bacteriuria in pregnancy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CephalexinAlso: KeflexCephalexin will be prescribed for women with a positive urine culture but no symptoms of urinary tract infection. | Drug | 3-day treatment, 7-day treatment |
| NitrofurantoinAlso: MacrobidMacrobid will be prescribed for women allergic to penicillin with a positive urine culture but no symptoms of urinary tract infection. | Drug | 3-day treatment, 7-day treatment |
Primary outcome
Evidence that 3-day treatment is as effective as 7-day treatment of asymptomatic bacteriuria in pregnancy.
Time frame: Within 21 days of treatment
Comparison of percentage of women in each group with successful treatment or asymptomatic bacteriuria with negative urine culture 2 weeks after randomized treatment.
3 secondary outcomes
Comparison of development of cystitis during pregnancy.
Time frame: Until 6 weeks postpartum
The occurence of preterm delivery
Time frame: Assessed at the time of delivery
Comparison of development of pyelonephritis during pregnancy
Time frame: Until 6 weeks postpartum
Results and safety
The study was stopped early (reason given: Inability to enroll patients at anticipated rate.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2018.
- Background: PubMed 26560337Widmer 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.
- Background: PubMed 9378925Patterson 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.
- Background: PubMed 2927852Romero 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cephalexin and Nitrofurantoin in people with Bacteriuria (Asymptomatic) in Pregnancy, run by Trinity Health Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Inability to enroll patients at anticipated rate.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence that 3-day treatment is as effective as 7-day treatment of asymptomatic bacteriuria in pregnancy. (time frame: Within 21 days of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02911662, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2018.