A double-blind, randomised, multi-centre, controlled clinical trial to compare D-mannose versus antibiotic in the treatment of acute uncomplicated lower urinary tract infections in female patients

Phase 1

• Conditions: acute uncomplicated lower urinary tract infections; MedDRA version: 20.0Level: LLTClassification code 10024981Term: Lower urinary tract infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2021-003466-12-DE
• Lead Sponsor: MCM Klosterfrau Vertriebsgesellschaft mbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-16
• Last Update Posted: 22 April 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

1.Female outpatients aged 18 to 70 years
2.Clinical signs and symptoms of an acute uncomplicated cystitis (e.g. dysuria, pollakisuria, and / or urgency to urinate) starting not earlier than 72 hours prior to trial enrolment at Visit 1
3.Signed informed consent and data protection form
4.ACSS-Typical” domain score is =6 at Visit 1
5.Urine dipstick test (midstream sample) is positive for leukocytes at Visit 1

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 112
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8

Exclusion Criteria

1.Males
2.Pregnant or lactating females or females of childbearing potential who are not using an effective method of contraception
3.Females with episodes of acute cystitis within 4 weeks before enrolment (Visit 1) or females with =3 episodes of acute cystitis within 6 months before enrolment
4.Anamnestic proof of presence of any predisposing factors or any conditions that may promote or lead to (complicated) urinary tract infections (i.e., anamnestic proof of renal insufficiency, renal calculi, polycystic kidneys, urinary tract abnormalities or past urinary surgery, urine catheterisation, spinal cord injury, etc.)
5.Anamnestic proof of renal impairment (creatinine clearance <30 mL / min)
6.Anamnestic proof of diabetes mellitus (Type I and II)
7.Any signs of pyelonephritis (i.e., fever =38.0°C tympanic, flank and / or back pain, chills or shivers)
8.Vulvovaginitis with abnormal vaginal and / or with urethral discharge (without urination) at Visit 1
9.Known or suspected hypersensitivity to one or more of the ingredients of the test product (Femannose® N) and / or comparator (Fosfomycin HEXAL®) and / or any placebo used
10.Systemic or local (i.e. vaginal) treatment with antibiotics within 7 days prior to Visit 1
11.Treatment with analgesics (e.g. nonsteroidal anti-inflammatory drugs, NSAIDs) within 6 hours prior to Visit 1
12.Parallel participation in another clinical study or trial, participation in a clinical study or trial within the previous 4 weeks prior to Visit 1, or previous participation in this clinical trial
13.Known to be or suspected of being unable to comply with the trial protocol (e.g. no permanent address, history of or (and) known drug abuse, known to be non-compliant or presenting an unstable psychiatric history)
14.Legal incapacity and / or other circumstances which makes the subject unable to understand the nature, scope and possible impact of the investigation
15.Custody by juridical or official order
16.Evidence of an uncooperative attitude (non-compliance)
17.Difficulties in understanding the language in which the informed consent and data protection declaration is given
18.Investigational site staff, staff of the sponsor or involved clinical research organisation (CRO), the investigator him- / herself or close relatives

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified