CystitisPhase 4NCT03275623
Management of Sub-Clinical Bacteriuria in Pregnancy
A Phase 4 study testing Antibiotic and Standard Prenatal Care in people with Cystitis and Cystitis;Puerperium, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cystitis, Cystitis;Puerperium, Pyelonephritis
- What is being tested?
- Antibiotic and Standard Prenatal Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2017to 18 Mar 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pregnant women who seek prenatal care within the University of Texas Health System with UT Physicians.
- Urine culture of less than 100,000 CFU
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
Official title: Management of Sub-Clinical Bacteriuria in Pregnancy: A Feasibility Trial
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.
- Conditions
- Cystitis, Cystitis;Puerperium, Pyelonephritis
- Being tested
- Antibiotic, Standard Prenatal Care
- Medical subject headings
- Cystitis, Pyelonephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Standard Prenatal CareOther
Continued surveillance of urinary cultures
| Study group | Role | What they receive |
|---|---|---|
| Antibiotic treatment | Active comparator | Standard prenatal care with treatment for any urine culture with growth of 1- 100,000 CFU of any organism. Receives: Drug: Antibiotic; Other: 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. Receives: Other: Standard Prenatal Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Have Cystitis
Cystitis is defined as a urine culture with >100,000 CFU at any point during antenatal care.
Measured: 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.
Measured: about 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2017
- Study start15 Sep 2017
- Primary completion18 Mar 2019
- Study completion18 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CystitisStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Akwugo Adanna Eziefule, The University of Texas Health Science Center, Houston
- Investigators
- Akwugo A Eziefule, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03275623
- Sponsor's protocol ID
- HSC-MS-17-0294
- Status last verified
- Mar 2020
- First submitted
- 5 Sep 2017
- Last updated
- 3 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Sub-Clinical Bacteriuria in Pregnancy: A Feasibility Trial
- ClinicalTrials.gov ID
- NCT03275623
- Acronym / sponsor ID
- HSC-MS-17-0294
- Conditions
- Cystitis, Cystitis;Puerperium, Pyelonephritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 15 Sep 2017 (actual)
- Primary completion
- 18 Mar 2019 (actual)
- Study completion
- 18 Mar 2019 (actual)
- First posted
- 7 Sep 2017 (actual)
- Results
- Posted 3 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antibiotic treatment | Active comparator | Drug: Antibiotic, Other: Standard Prenatal CareStandard prenatal care with treatment for any urine culture with growth of 1- 100,000 CFU of any organism. |
| No antibiotic treatment | Active comparator | Other: Standard Prenatal CareStandard prenatal care without treatment for any urine culture with growth of 1- 100,000 CFU of any organism. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Pregnant women who seek prenatal care within the University of Texas Health System with UT Physicians.
- Urine culture of less than 100,000 CFU
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| AntibioticThose 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. | Drug | Antibiotic treatment |
| Standard Prenatal CareContinued surveillance of urinary cultures | Other | Antibiotic treatment, No antibiotic treatment |
Primary outcome
Number of Participants Who Have Cystitis
Time frame: about 10 months
Cystitis is defined as a urine culture with >100,000 CFU at any point during antenatal care.
Number of Participants Who Have Pyelonephritis
Time frame: about 10 months
Pyelonephritis is defined as a urine culture with >100,000 CFU with fever at any point during antenatal care.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Akwugo A Eziefule, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Antibiotic and Standard Prenatal Care in people with Cystitis and Cystitis;Puerperium, run by The University of Texas Health Science Center, Houston 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 6 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: finished, as of the sponsor's last update on 3 Apr 2020. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Who Have Cystitis (time frame: about 10 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Apr 2020.