A Phase 4 interventional study of Arctuvan and Fosfomycin in Urinary Tract Infections, sponsored by University Medical Center Goettingen. Completed at 47 sites in Germany. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-11-27.
Sponsored by University Medical Center Goettingen · Phase 4, Interventional, and Treatment
It is well known that "over-treatment" of straightforward infections should be avoided as far as possible. Evidence-based data on non antibiotic treatment options for common conditions are therefore needed urgently. This randomised-controlled double blind trial examines whether initial herbal treatment with Uva Ursi, and antibiotic treatment only if symptoms persist, reduces antibiotic consumption in uncomplicated urinary tract infections (UTI) without a negative effect on symptom course and rate of recurrent UTIs. In total, 430 patients presenting with typical UTI symptoms will be included by their GPs and receive randomised either herbal treatment with uva ursi (antibiotics only if symptoms persist), or initial antibiotic treatment. Patients record symptom severity and drug intake in a diary and complete a final questionnaire after 28 days.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 398 is above the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →University Medical Center Goettingen is the lead sponsor of 61 studies on the registry; 27 are open to participants now.
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Exclusion Criteria:
placebo to fosfomycin: 3 g granules orally 1x1 (day 0) and Uva Ursi: 105 mg (Arctuvan®) 3x2 tablets orally from day 0 for 5 days
Drug: Arctuvan · Drug: Placebo to Fosfomycin
fosfomycin (Monuril®): 3 g granules orally 1x1 (day 0), and placebo to Uva Ursi: 3x2 tablets orally from day 0 for 5 days If the patient returns with persistent/recurrent symptoms, antibiotic therapy according to the sensitivity test.
Drug: Fosfomycin · Drug: Placebo to Arctuvan
application of a herbal drug
application of an antibiotic drug
application of Placebo to Arctuvan
application of Placebo to Fosfomycin
antibiotic courses
number of antibiotic courses from day 0 to day 28
Time frame: day 0-28
symptom burden
symptom burden (AUC) from day 0 to day 7
Time frame: day 0-7
early relapses
number of early relapses until day 14
Time frame: day 0-14
recurrent UTI
number of recurrent UTI day 15-28
Time frame: day 15-28
symptom resolution
number of patients with symptom resolution on day 4/7
Time frame: day 4 and 7
symptom sum score by patients' questionnaire
mean daily symptom sum scores from day 0 to day 7; Each of the symptoms dysuria, urgency, frequency and lower abdominal pain is scored daily on a five point scale from 0 "none" to 4 "very strong" in a patients' questionnaire.
Time frame: day 0-7
symptom burden for dysuria
symptom burden (AUC) for dysuria scored daily on a five point scale from 0 "none" to 4 "very strong", from day 0 to day 7
Time frame: day 0-7
symptom burden positive urine culture
symptom burden (AUC) day 0-7 of patients with positive urine culture
Time frame: day 0-7
symptom burden negative urine culture
symptom burden (AUC) day 0-7 of patients with negative urine culture
Time frame: day 0-7
activity impairment by UTI symptoms, measured as AUC
activity impairment by UTI symptoms (days 0-7), measured as AUC. Impairment by each UTI symptom is scored daily on a five point scale from 0 "none" to 4 "very strong".
Time frame: day 0-7
painkillers
use of painkillers (Defined Daily Dose (DDD) day 0-7)
Time frame: day 0-7
patients taking painkillers
number of patients taking painkillers
Time frame: day 28
antibiotic use
antibiotic use (defined daily dose (DDD) day 0-28)
Time frame: day 0-28
UTI related visits
number of UTI related visits day 0-28
Time frame: day 0-28
UTI related sick leave
number of days of UTI related sick leave day 0-28
Time frame: day 0-28
patients with poor outcome: temperature
number of patients with temperature \>38°C, day 0-7, according to patients´ statement
Time frame: day 0-7
patients with poor outcome: worsening symptoms
number of patients with worsening symptoms (impairment in symptom score)
Time frame: day 28
patients with poor outcome: prolonged symptoms
number of patients with prolonged symptoms (\> 7 days), day 0-28. Patients will be followed up until symptom resolution, defined as max. 1 score point on each symptom scale.
Time frame: day 0-28
pyelonephritis
number of pyelonephritis day 0-28, according to GP´s diagnosis
Time frame: day 0-28
AE and SAE
number of AE and SAE by system organ class day 0-28
Time frame: day 0-28
patients with at least 1 AE/ 2 AE
proportion of patients with at least 1 AE/ 2 AE
Time frame: day 28
symptom burden for urgency
symptom burden (AUC) for urgency scored daily on a five point scale from 0 "none" to 4 "very strong", from day 0 to day 7
Time frame: day 0-7
symptom burden for frequency
symptom burden (AUC) for frequency scored daily on a five point scale from 0 "none" to 4 "very strong", from day 0 to day 7
Time frame: day 0-7
symptom burden for lower abdominal pain
symptom burden (AUC) for lower abdominal pain scored daily on a five point scale from 0 "none" to 4 "very strong", from day 0 to day 7
Time frame: day 0-7
This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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University Medical Center Goettingen