Clinical Effectiveness and Bacteriological Eradication of 4 Short-course Antibiotics for Uncomplicated UTIs in Women.

Launched by FUNDACIO D'INVESTIGACIO EN ATENCIO PRIMARIA JORDI GOL I GURINA · Jul 12, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of four different short-term antibiotics for treating uncomplicated urinary tract infections (UTIs) in women. The researchers want to see how well these antibiotics work in relieving UTI symptoms and eliminating bacteria from the urine. Women aged 18 and older who have symptoms like painful urination, urgency, or frequent trips to the bathroom, along with a positive urine test, may be eligible to participate. However, women with certain conditions, such as pregnancy, severe kidney issues, or those currently on antibiotics, will not be included in the study.

Participants in the trial will be randomly assigned to one of four treatment groups, where they will receive either a 2-day dose of fosfomycin, a 3-day course of pivmecillinam, a 5-day course of nitrofurantoin, or a single dose of fosfomycin. After starting the treatment, they will have follow-up calls and visits at 7, 14, and 28 days to check on their progress and collect urine samples to test for bacteria. This trial is currently recruiting participants, and it aims to help improve treatment options for women suffering from UTIs.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• Women of 18 years of age or older, with clinical features of uncomplicated community-acquired lower urinary tract infection including:
• • At least one of four key symptoms of lower urinary tract infection: dysuria, urgency including nycturia, frequency, and suprapubic tenderness that could be attributed to an uncomplicated lower urinary tract infection, and no alternative explanation (i.e. symptoms suggestive of sexually-transmitted infection or vulvovaginitis), and
• • A urine dipstick analysis positive for either nitrites or leukocyte esterase.
• Exclusion Criteria:
• • Male sex
• • High suspicion of pyelonephritis (i.e. fever ≥ 37.5°C or flank pain/tenderness)
• • Any condition that may lead or predispose to complicated urinary infection (i.e. indwelling urinary catheter, pregnancy, immunosuppressive therapy, abnormal urinary tracts, recurrent urinary tract infection, severe neurological disease affecting the bladder)
• • Pregnancy or planned pregnancy
• • Symptoms consistent with urinary tract infection in the preceding 4 weeks
• • Patients taking long-term antibiotic prophylaxis
• • Ongoing antibiotic therapy or use of any systemic antibiotic in the previous 7 days
• • Symptoms correlating with differential diagnosis (i.e. vaginal discharge or pain)
• • Hypersensitivity or allergy to β lactams, nitrofurantoin and/or fosfomycin
• • Moderate to severe chronic renal insufficiency
• • Pre-existing polyneuropathy
• • History of lung or liver reaction or peripheral neuropathy after previous use of nitrofurantoin
• • Glucose-6-phosphate dehydrogenase deficiency
• • Porphyria or systemic primary carnitine deficiency or of the type organic aciduria (i.e. methylmalonic aciduria and propionicacidaemia)
• • Esophageal stricture
• • Current intake of allopurinol or probenecid or valproate
• • Currently part of another randomized clinical trial
• • Previous enrolment in the proposed study
• • Patients living in long-term institutions; and/or
• • Difficulty in conducting scheduled follow-up visits