A Phase 4 interventional study of Nitrofurantoin and Gentamicin in Urinary Tract Infections, sponsored by Mayo Clinic. Withdrawn. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-06-06.
Sponsored by Mayo Clinic · Phase 4, Interventional, and Treatment
Women have problems with oral antibiotics, including vagina and bowel infections. Also, bacteria causing urinary infections are becoming more resistant to oral antibiotis. Placement of antibiotic directly into the bladder does not cause these problems and are at doses that are may be able to stop bacteria from being resistant to antibiotics.
Each participant once enrolled returns with an active Urinary Tract Infection (UTI), confirmed by urine void. Participants will complete an UTI questionnaire, and if consistent with a simple non-febrile UTI will be randomized to one of two arms: oral nitrofurantoin treatment for 7 days, or intravesical gentamicin instillation once a day for three days. Patients will be followed for symptom relief with a repeat voided urine in 7 to 10 days, and with a repeated questionnaire for symptom relief.
Exclusion Criteria:
Participants will randomized to oral nitrofurantoin
Drug: Nitrofurantoin
Participants will be randomized to intravesical gentamicin
Drug: Gentamicin
Participants will receive oral Nitrofurantoin 100 mg twice daily for 7 days
Also known as: Macrobid, Furadantin, Macrodantin
Participants will receive intravesical via catheter Gentamicin solution 25 mg in 50cc for 3 days
Also known as: Gentak, Garamycin
Change in microbiologic effect of a chronic acute Urinary Tract Infection
Microbiological culture growth of susceptible organisms obtained on day 0, compared with voided urine culture as no growth in 24-48 hours obtained at 7-10 days
Time frame: baseline, 7-10 days
Change in symptomatic relief of a chronic acute Urinary Tract Infection
Completion of a Symptom Urinary Tract Questionnaire. Tracking the symptoms in the past 24 hours. Indicating how severe and how bothersome they were. Severe ranging from 0 (Did not have) to 3 (Severe). Bothersome ranging from 0 (Not at all) to 3 (A lot)
Time frame: baseline, 7-10 days
To establish the clinical FTE needs for providing urgent intravesical treatments
Nursing needs to provide intravesical treatments of acute Urinary Tract Infections (UTI) in women with chronic recurrent UTIs. Measured in amount of participants and FTE requirement for nursing staff.
Time frame: baseline, through stufy completion, an average of one year
No study locations are listed for this record.
Plan to share: No
This study is withdrawn, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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