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Urology Practice Management - August 2015, Vol 4, No 4 - Clinical Trials Tracker

The following clinical trials are currently recruiting patients with urinary tract infections for inclusion in several investigations. Each trial description includes the NLM Identifier to use as a reference with Clinical Trials.gov.


1. Short-Course Therapy for Urinary Tract Infections in Children

This phase 2, randomized, double-blind clinical trial compares the incidence of treatment failures in children with urinary tract infections (UTIs) who receive antibiotics for 5 days followed by 5 days of placebo (ie, no active medication) versus 10 days of antibiotic therapy. Patients aged 2 months to 10 years with >1 symptom that is consistent with a UTI diagnosis (ie, fever; dysuria; suprapubic, abdominal, or flank pain or tenderness; or urinary urgency, frequency, or hesitancy in children aged >2 years; poor feeding or vomiting in patients aged ≥2 months to 2 years) who are able to take oral medications and who do not have catheter-associated UTI may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive (1) 10 days of active antibiotic therapy, or (2) 5 days of therapy with active antibiotics followed by 5 days with a placebo.

The primary outcome measures are the incidence of treatment failure in the 2 therapy arms, and the comparison of efficacy based on symptomatic UTI as evaluated up to or during the test of cure visit. The secondary outcome measures include the incidence of recurrent infections, asymptomatic bacteriuria, and positive urine cultures. This study expects to enroll 746 patients in Pittsburgh and in Philadelphia, PA. For more information, contact Theoklis Zaoutis, MD, MSCE, at 267-426-5570 or zaoutis@email.chop.edu, or Alejandro Hoberman, MD, at 412-999-3277 or hoberman@chp.edu. The NLM Identifier is NCT01595529.

2. Longer versus Shorter Treatment Duration of Urinary Tract Infections in Men

This double-blind, randomized, parallel-assignment trial examines whether the treatment of UTIs in men with antibiotic therapy for 7 days (shorter duration) is worse than antibiotic therapy administered for 14 days (longer duration). Men aged ≥18 years with a new onset of dysuria, urinary frequency, urgency, hematuria, perineal pain, suprapubic pain, costovertebral angle tenderness, or flank pain in the past 7 days may be eligible to enroll if other criteria are met. Patients who qualify will be randomized to receive antimicrobial treatment for 14 days or for 7 days.

The primary outcome measure is the resolution of UTI symptoms 14 days after the completion of antimicrobial therapy, which will be assessed in a binary manner. The secondary outcome measures include recurrent UTI or adverse drug events within 28 days after study completion. This study expects to enroll 319 patients in Minneapolis, MN. For more information, contact Dimitri M. Drekonja, MD, at Dimitri.Drekonja@va.gov, or Hanna E. Bloomfield, MD, MPH, at 612-467-2682 or hanna.bloomfield@va.gov. The NLM Identifier is NCT01994538.

3. Corticosteroids Use in Children with Febrile Urinary Tract Infections


In this phase 3, double-blind, randomized trial, investigators aim to determine whether corticosteroids that are administered during a UTI help to prevent permanent kidney damage in children. Patients aged 2 months to 6 years with fever, pyuria, and no known bacteremia may be eligible for enrollment if other criteria are met. Participants will be randomized to receive 0.15 mg/kg of dexamethasone twice daily for 3 days or placebo twice daily for 3 days.

The primary outcome measure is the number of children who have renal scars on the outcome DMSA scan, and the secondary outcome measure is the proportion of children with grade 3 or 4 scarring on ≥1 kidney. This study expects to enroll 390 patients, combined, in Washington, DC; Columbus, OH; Pittsburgh, PA; Providence, RI; and Madison, WI. For more information, contact Nader Shaikh, MD, at 412-692-8111 or nader.shaikh@chp.edu, or Diana Kearney, CCRC, at 412-692-6717 or diana.kearney@chp.edu. The NLM Identifier is NCT01391793.

4. Foley Catheters for Adult Patients with Spinal Cord Injuries


The purpose of this randomized, double-blind, parallel-assignment study is to determine whether a Foley catheter with a patterned, external surface can delay the time to onset of UTIs in patients with spinal cord injuries who are dependent on a Foley catheter for draining their bladder. Patients aged ≥21 years who are hospitalized in 1 of the 2 participating spinal cord injury units, and who require insertion or exchange of a Foley catheter for no longer than 15 days, may be eligible to enroll if other criteria are met. Participants will be randomized to receive a micropatterned Foley catheter or a standard-of-care Foley catheter.

The primary outcome measure is the delayed onset of catheter-associated symptomatic UTIs. The secondary outcome measures include time to the occurrence of asymptomatic bacteriuria or funguria, evaluation of the microbial coverage and biofilm formation on the catheter surface (on day 15 or at removal of a Foley catheter), and device-specific adverse event assessments. The study plans to enroll 300 patients in Tampa, FL, and in Houston, TX. For more information, contact Brittany Durant, RN, at 813-972-2000 (ext. 1014) or brittany.durant@va.gov, or Colleen A. Cerra-Stewart, RN, MN, at 713-794-7127 or colleen.cerra-stewart@va.gov. The NLM Identifier is NCT02198833.

5. Eravacycline versus Levofloxacin for Complicated Urinary Tract Infections

The purpose of this international, randomized, double-blind, phase 3 clinical trial is to assess the safety and efficacy of eravacycline versus levofloxacin in patients with complicated UTIs. Patients aged ≥18 years who have pyelonephritis and a normal urinary tract anatomy or a complicated UTI may be eligible to enroll if other criteria are met. Participants will be randomized to receive intravenous and oral eravacycline, or oral levofloxacin.

The primary outcome measure is the clinical and microbiologic response versus failure rate, assessed 6 to 8 days after the completion of the therapy. The study plans to enroll 840 patients in multiple locations across the United States and abroad. For more information, contact Kevin Lloyd at 617-715-3589 or klloyd@tphase.com. The NLM Identifier is NCT01978938.

6. Imipenem plus Cilastatin, with or without MK-7655, for Complicated Urinary Tract Infections


This phase 2, randomized, double-blind clinical trial seeks to evaluate the efficacy, safety, and tolerability of adding 125-mg or 250-mg doses of MK-7655 to imipenem plus cilastatin in patients with complicated UTIs. Patients aged ≥18 years with clinically suspected and/or bacteriologically documented complicated UTIs or with acute pyelonephritis, pyuria, and 1 positive urine culture within 48 hours of enrollment may be eligible to participate if other criteria are met. Participants will receive 250 mg of MK-7655 intravenously with 500 mg of intravenous (IV) imipenem and IV cilastatin, 125 mg IV MK7655 with 500 mg IV of imipenem plus 500 mg IV of cilastatin, or a matching placebo to IV MK-7655 with 500 mg each of imipenem and cilastatin.

The primary outcome measures include the proportion of participants with a favorable microbiologic response, an elevated aspartate aminotransferase or alanine aminotransferase laboratory value that is ≥5 times the upper limit of normal, and any adverse events. The secondary outcome measures include the proportion of patients with a favorable microbiologic response at study completion who have imipenem-resistant, gram-negative, complicated UTIs, and the percentage of participants with a favorable clinical response at early follow-up. The study plans to enroll 300 patients combined in Alabama, Massachusetts, Michigan, Minnesota, and New Jersey. For more information, call 888-577-8839 toll-free. The NLM Identifier is NCT01505634.

7. Vaginal Estrogen for Recurrent Urinary Tract Infection in Postmenopausal Women


Investigators in this phase 4, randomized, single-blind clinical trial are evaluating whether the use of vaginally applied estrogen can prevent repeated UTIs in postmenopausal women. Patients aged ≥18 years with a postmenopausal status and recurrent UTIs documented by cultures who do not have diagnosed interstitial cystitis may be eligible for enrollment if other criteria are met. Participants will be randomized to receive 0.5 g of conjugated estrogen vaginal cream twice weekly, an estradiol vaginal ring every 3 months, or a vaginally administered placebo.

The primary outcome measure is the frequency of UTIs in postmenopausal women with a history of recurrent UTIs at 6 months. The secondary outcome measures include the rates of UTIs, the patients’ quality of life, adherence to treatment, and the efficacy of vaginal estrogen use at 12 months. This study expects to enroll 138 patients in La Jolla, CA. For more information, contact Kimberly Ferrante, MD, at 619-290-4113 or klferrante@ucsd.edu. The NLM Identifier is NCT01958073.

8. Gentamicin Bladder Instillation for the Prevention of Urinary Tract Infections


This phase 4, randomized, placebo­controlled study will examine the use of gentamicin bladder instillation to prevent UTIs in patients at high risk for cystitis associated with intermittent catheterization. Patients aged ≥16 years with a history of recurrent, symptomatic UTIs (ie, ≥3 annually) who are not currently receiving oral or intravesical antibiotic prophylaxis and who are able to travel quarterly to the Gillette Lifetime Specialty Healthcare clinic for urine cultures, may be eligible for enrollment if other criteria are met. Eligible participants will be randomized to receive a nightly instillation of gentamicin 120 mg into the bladder (which will remain overnight and be drained out in the morning) or placebo, for a duration of 1 year.

The primary outcome measures are febrile or symptomatic UTIs (ie, fever, abdominal pain, or new bladder symptoms, such as pain, urinary incontinence, or hematuria). The secondary outcome measures are asymp­tomatic UTIs, which are evaluated by quarterly urine cultures. This study expects to enroll 24 patients in Saint Paul, MN. For more information, contact Meghan E. Munger, MPH, at 651-229-1757 or meghanemunger@gillettechildrens.com, or Kari A. Williams, MPH, CCRC, at 651-324-2316 or kariawilliams@gillettechildrens.com. The NLM Identifier is NCT01884467.

9. Antibiotic Prophylaxis for Decreasing Urinary Tract Infections After Radical Prostatectomy

The purpose of this randomized, open-label, parallel-assignment study is to determine whether the use of antibiotic prophylaxis at the time of urinary catheter removal decreases the number of symptomatic UTIs after a radical prostatectomy. Men aged ≥18 years who are undergoing a radical prostatectomy for prostate cancer and who do not have a history of adverse reactions to ciprofloxacin or to any other quinolone may be eligible for enrollment if other criteria are met. Participants will be randomized to receive ciprofloxacin or no antibiotics.

The primary outcome measures are the metrics for resistant bacteria in the patient’s urine, which will be assessed by a urine culture. The secondary outcome measures are the development of Clostridium difficile, resistant bacteria in the urine, and adverse events related to the use of ciprofloxacin. The study plans to enroll 280 patients in Rochester, NY. For more information, contact Jean V. Joseph, MD, at 585-341-7795 or jean_joseph@urmc.rochester.edu, or Claudia Berrondo, MD, at 585-275-0989 or claudia_berrondo@urmc.rochester.edu. The NLM Identifier is NCT02247960.

10. The Use of Bidet versus Usual Toileting to Reduce Urinary Tract Infections

Investigators in this randomized, parallel-assignment, open-label trial seek to determine whether regular bidet use can improve the quality of life regarding elimination for adults with impaired functional status, as well as their caregivers, and reduce the incidence, frequency, and severity of constipation. The trial will also examine whether regular bidet use can reduce the incidence of UTIs in adult women with impaired functional status. Patients aged 21 to 95 years, with or without impaired functional status, who have a life expectancy of >2 years, and who do not have indwelling urinary catheters may be eligible for enrollment if other criteria are met. Patients will be randomized to use a bidet or a toilet as they usually do for 2 years. The caregivers of participants with impaired functional status will also be enrolled in the trial and will be randomized together with the patient under their care.

The primary outcome measure is improved quality of life, which will be evaluated using a validated quality-of-life questionnaire that has been altered to include toilet-related questions, and the burden for caregivers of adults with functional impairments using a validated caregiver burden questionnaire. The secondary outcome measures are the incidence of UTIs, as well as the incidence and severity of constipation in patients in both arms. This study expects to enroll 400 patients and their caregivers in Stanford, CA. For more information, contact Yusra N. Hussain, MD, at 650-714-3343 or ynhussen@stanford.edu, or Isabella Chu, MPH, at 650-723-2513 or isabella.chu@stanford.edu. The NLM Identifier is NCT02042157.

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Last modified: August 17, 2015
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