Clinical trial: Controlled Human Urine Transfusion for UTI (NCT03142295)

Eligibility criteria:
Inclusion Criteria:

          -  Subject is premenopausal, aged ≥ 18 and ≤45 years

          -  Subject had recurrent UTI's (≥3 documented UTI's in the last year with documented
             symptom-free interval of at least 2 weeks) following the definition of a urinary tract
             infection: the presence of significance bacteruria (10^3 CFU/ml or more), pyuria and
             fever plus one or more of the following signs and symptoms: suprapubic or flank
             discomfort, dysuria, bladder spasms or pollakiuria

          -  Subject has a documented urinary tract infection (see definition), for which oral
             antibiotic therapy has been initiated.

          -  Subject has adequate understanding of the procedures of the study and agrees to abide
             strictly thereby.

          -  Subject is able to communicate well with the investigators and is available to attend
             all study visits.

          -  Subject has signed informed consent.

          -  Subject will remain available during the first 3 weeks of the study period
             (recruiting, intervention and first follow-up).

        Exclusion Criteria:

          -  Any history, or evidence at screening, of clinically significant symptoms, physical
             signs or abnormal laboratory values suggestive of systemic conditions, such as
             cardiovascular, pulmonary, renal, hepatic, neurological, dermatological, endocrine,
             malignant, haematological, immune-deficient, psychiatric and other disorders, which
             could compromise the health of the recipient during the study. These include, but are
             not limited to, any of the following: positive HIV, HBV or HCV screening tests; the
             use of immune modifying drugs within three months prior to study onset (inhaled and
             topical corticosteroids and oral anti-histamines exempted) or expected use of such
             during the study period.

          -  Documented vesico-urethral reflux

          -  Documented urinary retention > 100 milliliters post-void residual urine

          -  Anatomic urogenital abnormalities

          -  Urolithiasis

          -  Nephrostomy catheters

          -  Extra-urogenital infections that require prolonged antibiotic therapy

          -  Pregnancy

          -  Use of probiotics and or cranberry juice

          -  Allergy or intolerance for multiple common prescribed antibiotics

          -  Carriage of multi drug resistant organisms in faeces and/or urine without regular
             antibiotic treatment options
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 45 Years

Patient description (medical language): A 32-year-old woman comes to the hospital with vaginal spotting.  Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal.  Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL.  Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus.

Patient description (patient's own words): I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule.

Does the patient match the trial criteria? 0