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View Clinical Trial (Medical Research Study)
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Prevention of Urinary Tract Infection (UTI) in Persons With Spinal Cord Injury (SCI) - NCT00309114-60611 (Clinical Trial 139158)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy139158.aspx
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| City: |
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Chicago |
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State:
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IL |
| Zip Code: |
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60611 |
| Conditions: |
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Urinary Tract Infections |
| Purpose: |
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Urinary tract infection (UTI) is the most common infection in patients with spinal cord
injury (SCI) and is linked to major undesired results or complications including death. The
bladder of SCI patients, especially those with indwelling catheters, is usually colonized by
bacteria, some of which do and others which do not cause symptoms of UTI. Bacteria that do
not cause symptoms are often called benign colonizers and are often left untreated because
they may provide some protection against infection with more harmful bacteria. This idea of
using benign bacteria to prevent infections with symptoms is called bacterial interference.
A prototype strain, Escherichia coli 83972, was shown to begin and continue for extended
periods of time non symptom causing colonization of the human bladder and to hold back
symptom causing infections of the neurogenic bladder. Data from pilot studies at two
medical centers indicated that bacterial interference might be a useful therapy for reducing
the rate or frequency of UTI in SCI patients. Because almost all SCI patients have a UTI at
some time, and also the large costs of treating this infection, studying the impact of
bladder colonization with E. coli 83972 on the rate of symptom causing UTI has an amazing
potential for improving the quality of life of SCI patients and decreasing the cost of
health care. Like with other preventive plans such as vaccination, for instance, it is
important to explore the effectiveness of this new preventive approach. The project is a
prospective, randomized, double blind, multi-center study that deals with specific pieces of
bacterial interference in SCI patients.
HYPOTHESES: Placing non symptom causing bacteria (E. coli 83972) into SCI patients'
bladders reduces the rate of symptom causing UTI.
A. SPECIFIC AIM: Determine how bladder colonization with E. coli 83972 or similar bacteria
affects the rate of symptom causing urinary tract infections in a large group of SCI and
Spina Bifida patients by conducting a prospective, randomized, placebo-controlled,
multi-center clinical trial.
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| Study summary: |
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This clinical trial will be take place in a total of 5 medical centers that care for Spinal
cord injury (SCI) and Spina Bifida patients. A total of 160 patients will be allowed to
take part in the study.
The study coordinator will interview patients by telephone and in person who express an
interest in taking part in the study. After an informed consent and HIPAA documents are
reviewed and all of the patients questions are answered, then they will be asked to sign
these two forms. Then a code number will be assigned to each patient and used along with
their initials to identify them for the remainder of the study. All study participants will
have a complete history and physical examination including ASIA classification, serum
creatinine and a urine culture immediately upon entry into the study. One of the following
3 diagnostic tests must be completed within the 3 months before the study: KUB, IVP, or
non-contrast abdominal CT scan. A voiding cystourethrogram with fluoroscopy (VCUG) alone or
as part of a video urodynamics evaluation must be completed within 1 year before the study.
Randomization and sample size: Enrolled subjects will be randomized in a 3:1 ratio to
receive bladder inoculation either with E. coli 83972 (experimental group) or with placebo
(control group). This randomization ratio was selected because around 1/3 of colonized
subjects are expected to remain colonized for 12 months.
Bladder inoculation: At study entry, a urine culture and sensitivity test will be completed
using a fresh mid stream (after the urine is flowing) urine sample removed via a catheter
into the bladder. Subjects will stop all actions to prevent or slow urinary tract infection
(UTI) for at least two weeks upon entry into the study. Each subject will be treated with
correct antibiotics for 7 – 10 days and any existing urinary catheter changed three days
after starting antibiotic treatment. Forty-eight to 72 hours or (80 to 90 hours for
fluoroquinolone antibiotics) after completion of antibiotics, the urine will be re-cultured
and the lower urinary tract inoculated with E. coli 83972 or placebo.
Most subjects, even those with external condom catheters, have worn a Foley catheter at some
time, and would be expected to know the catheter size that best fits them. Subjects will be
inoculated on three consecutive days. Inoculation will consist of putting into the bladder
via a sterile catheter 10 ml of normal saline alone or containing E. coli 83972. Subjects
who are incontinent at low bladder volumes will be monitored with a Foley catheter balloon
blocking the bladder neck or diversion stoma for 30 minutes after inoculation. After 30
min., the clamp will be released and the bladder allowed to drain for an additional 30 min.
The bladder inoculation will be repeated a second time unless an unexpected adverse event
(complication) is encountered. After the catheter is un-clamped for the second time, the
subject will be observed for 30 min. before discharge.
If the 48-hour culture from the sample taken just prior to inoculation is positive for
bacteria, and E. coli 83972 colonization was not present in the sample, another antibiotic
treatment/inoculation cycle will be attempted. The timing of the second attempt will be
decided by the CORE director and the local principal investigator. At the correct time,
another 7-10 day course of antibiotic therapy will be repeated. Three days after starting
antibiotics, any existing urinary catheter will be changed. Forty-eight to 72 hours or (80
to 90 hours for fluoroquinolone antibiotics) after completion of this course of antibiotics,
the urine will be re-cultured and then the bladder re-inoculated. If the 48 hour culture
taken just prior to this inoculation is again positive for any bacteria other than E. coli
83972, and E. coli 83972 colonization is not present as a result of the second inoculation
cycle, a third cycle of antibiotic treatment/inoculation will be attempted. The timing of
the 3rd attempt will be decided by the CORE director and the local principal investigator.
No further colonization attempts will be made in study participants who are not colonized
after three sets of attempts. We will continue to monitor subjects in this group for the
remaining months of the study, but for analysis purposes, they will be treated as "never
colonized”.
All inoculated subjects who remain without symptoms will return to their study center to
have a urine sample collected and a brief medical interview one week after inoculation and
monthly for the remaining 12 months. The CORE director can allow a subject who lives far
from any center to mail their monthly urine samples directly to the CORE. All needed
supplies such as: urine specimen containers, proper shipping containers, labels, pre-paid
postage, etc.… will be provided at no cost to the subject. The subject’s study site will
contact them to conduct the brief medical interview.
At the end of 12 months, subjects will receive an antibiotic to clear E. coli 83972 from
their bladder and the study will be finished. If a subject experienced an adverse event
(something unexpected) during the study, they will be followed by the research staff until
the event has gone back to normal or resolved.
Growth of E. coli 83972 in the urine will indicate bladder colonization. Subjects will be
considered colonized as long as E. coli 83972 is present and even if there are other
bacteria in the urine. Subjects who develop symptoms of a UTI will be treated with proper
antibiotics guided by susceptibility patterns for the bacteria(s) grown from urine cultures.
Urine cultures collected prior to starting treatment will be tested for E. coli 83972. It
is important to note that although the method of bladder inoculation carries some risk of
causing symptoms of a UTI, that risk is rather small and will be shared by all subjects.
There exists a risk that clamping of the bladder for 30 minutes may result in autonomic
dysreflexia in some patients, especially those who dump urine. All subjects will be asked
about a history of autonomic dysreflexia or any unexpected response to bladder filling prior
to inoculation. Before beginning inoculation, urodynamics data will be reviewed. All
subjects with a lesion level above T7 will have their blood pressure (BP) monitored every 3
- 5 minutes while the catheter is clamped. If the subject reports any symptoms associated
with autonomic dysreflexia; e.g., headache, sweating, flushing and so forth, or if the BP
monitor records a systolic or diastolic BP 20 mm Hg above baseline or in any case, if the
systolic BP exceeds 150 or the diastolic BP exceeds 100 mm Hg, the catheter will be
un-clamped. Monitoring will continue until the subject is without symptoms with their
baseline BP's. Interventions, including elevating the head of the bed, lowering the legs,
as well as pharmacologic measures (nitropaste, nifedipine, etc.) will be used if needed.
The use of pharmacologic measures and any other measures will follow the Clinical Procedures
Guidelines for acute management of autonomic dysreflexia published by the Paralyzed Veterans
of America. |
| Criteria: |
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Inclusion Criteria:
- 15 years or older
- Living in institutional or non-institutional settings
- 6 months post spinal cord injury (SCI) prior to entry or have Spina Bifida
- Loss of bladder function
- Loss of normal bladder sensation
- Selected in-patients involved in the Rehab I program
- Catheter dependent, having either an indwelling urinary catheter or using an external
catheter, intermittent catheterization, or vesical urinary diversion (original
bladder, whole or in part, serves as the collection receptacle for urine) for bladder
management.
- Two or more urinary tract infections (UTI) within the 12 months prior to the study.
- Capable of understanding the purpose of the study and providing informed consent to
participate
- Pursue appropriate follow-up over the course of the study.
Exclusion Criteria:
- Any bladder stone(s)
- Kidney stone(s) greater than 1 cm in size
- Any obstructing kidney stone regardless of size
- Nephrostomy tube(s)
- Supravesical diversion (original bladder is no longer part of the collection
receptacle for urine)
- Congenital genitourinary anomaly that predisposes to UTI
- Conditions anticipated to require recurrent antibiotic therapy for extraurogenital
infection (e.g., recurrent pneumonia, decubitus ulcer)
- Current immunosuppression
- Vascular prosthesis
- Congenital or acquired cardiac disease susceptible to vegetative infections
- Bladder capacity of less than 50 cc
- Individuals with known significant cognitive impairment resulting from trauma,
disease, or congenital conditions
- Women of childbearing age who engage in unprotected intercourse
- Women who are currently pregnant will be included in the study
- Women who become pregnant during the study will be discontinued from participation.
Pregnant women who experience UTI or prolonged asymptomatic bacteriuria are at risk
of bearing infants with low birth weight.
- Children
- Prisoners
- Men and women with significant known mental illness or emotional disorders related to
organic or inorganic causes. |
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| Study is available at: |
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Rehab Institute Chicago
Chicago, IL 60611
United States
Primary Contact:
Rabih Darouiche, MD
Email: rabih.darouiche@med.va.gov
Phone: 713-794-7117 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 15, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
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