Safety and tolerability of controlled Human Urine Transfusion for Urinary tract infection Prevention (SHUTUP): a pilot study - Controlled human urine transfusion for UTI

eids Universitair Medisch Centrum0 个研究点目标入组 6 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

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•1. Subject is premenopausal, aged * 18 and *45 years
•2. 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 (103
•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
•3. Subject has a documented urinary tract infection (see definition), for which
•oral antibiotic therapy has been initiated.
•4. Subject has adequate understanding of the procedures of the study and agrees
•to abide strictly thereby.
•5. Subject is able to communicate well with the investigators and is available
•to attend all study visits.
•6. Subject has signed informed consent.
•7. Subject will remain available during the first 3 weeks of the study period

•1. Any history or evidence at screening of clinically significant symptoms,
•physical signs or abnormal laboratory values suggestive of systemic conditions.
•2. 2. Documented vesico-urethral reflux
•3. Documented urinary retention > 100 milliliters post-void residual urine
•4. Anatomic urogenital abnormalities
•5. Urolithiasis
•6. Nephrostomy catheters
•7. Extraurogenital infections that require prolonged antibiotic therapy
•8. Pregnancy
•9. Use of probiotics and or cranberry juice
•10. Allergy or intolerance for multiple common prescribed antibiotics
•11. Carriage of multi drug resistant organisms in faeces and/or urine without
•regular antibiotic treatment options

发起方