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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-003466-12-DE

Enrollment

120

Registered

2021-12-16

Start date

2022-03-25

Completion date

Unknown

Last updated

2024-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute uncomplicated lower urinary tract infections MedDRA version: 20.0 Level: LLT Classification code 10024981 Term: Lower urinary tract infection System Organ Class: 10021881 - Infections and infestations

Interventions

Trade Name: Fosfomycin HEXAL® Product Name: Fosfomycin HEXAL® Pharmaceutical Form: Powder for use in drinking water Pharmaceutical form of the placebo: Powder for use in drinking water Route of admini

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: The current European Association of Urology guidelines on urological infections (EAU Guidelines 2020) recommend oral antibiotics (e.g. fosfomycin trometamol, pivmecillinam, nitrofurantoin) as first-line treatment for acute lower urinary tract infection (UTI, also called cystitis) in women. This randomised controlled clinical trial aims to investigate D-mannose (Femannose® N) as stand-alone therapy for acute uncomplicated UTI to point out possible strategies for the avoidance of so far common antibiotic use. ;Secondary Objective: Objectives: -To gain further information on clinical effectiveness and safety / tolerability of 5 days oral treatment with D-mannose in comparison to a single oral dose of fosfomycin with regard to clinical cure of acute uncomplicated cystitis in women -To compare the bacteriologic response to oral treatment with D-mannose and fosfomycin for acute uncomplicated cystitis -To assess the safety and tolerability of oral treatment with D-mannose and fosfomycin for acute uncomplicated cystitis ;Primary end point(s): not applicable ;Timepoint(s) of evaluation of this end point: not applicable	—

Measure

Time frame

Main Objective: The current European Association of Urology guidelines on urological infections (EAU Guidelines 2020) recommend oral antibiotics (e.g. fosfomycin trometamol, pivmecillinam, nitrofurantoin) as first-line treatment for acute lower urinary tract infection (UTI, also called cystitis) in women. This randomised controlled clinical trial aims to investigate D-mannose (Femannose® N) as stand-alone therapy for acute uncomplicated UTI to point out possible strategies for the avoidance of so far common antibiotic use. ;Secondary Objective: Objectives: -To gain further information on clinical effectiveness and safety / tolerability of 5 days oral treatment with D-mannose in comparison to a single oral dose of fosfomycin with regard to clinical cure of acute uncomplicated cystitis in women -To compare the bacteriologic response to oral treatment with D-mannose and fosfomycin for acute uncomplicated cystitis -To assess the safety and tolerability of oral treatment with D-mannose and fosfomycin for acute uncomplicated cystitis ;Primary end point(s): not applicable ;Timepoint(s) of evaluation of this end point: not applicable

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Secondary

Measure	Time frame
Secondary end point(s): Definitions: - CLINICAL CURE is defined as ACSS-“Typical” domain score =4 (sum of the 6 scores within the domain) whereby items 1-5 must be scored “1” (mild) or “0” (not present), and item 6 must be scored “0” (absence of haematuria, i.e. no visible blood in urine). - A positive urine culture is defined as either =10^3 CFU/mL of culture (with a maximum of 2 species) of uropathogens, or a positive mixed urine culture =10^3 CFU/mL as defined by the MIQ 02/2020 guidance. - A negative urine culture is defined as 1 on Day 8 6: Percentage of subjects with recurrence of UTI established by ACSS-“Typical” domain score =6 during the follow-up phase 7: Percentage of subjects with antibiotic therapy for acute UTI in the acute phase (Visit 1 – Visit 2, in addition to the trial treatment), in the follow-up phase (Visit 2 – Visit 3: recurrence by antibiotic therapy), and in both trial phases (Visit 1 – Visit 3) 8: Time to recurrence of UTI as determined by the first date of the ACSS-“Typical” domain score =6 during the follow-up phase 9: Time to recurrence of UTI as determined by the first date of antibiotic use for acute UTI during the follow-up phase 10: Change in ACSS-“Typical” domain score on Day 8 compared to Visit 1 11: Change in ACSS-“QoL” domain score on Day 4 and Day 8 each compared to Visit 1 12: Change in the total score calculated as the sum of the two domain scores ACSS-“Typical” and ACSS-“QoL” on Day 8 compared to Visit 1 13: Change in time course of the ACSS-“Dynamic” domain score from Day 1 to Day 8 14: Investigator’s and subject’s global judgement on efficacy at Visit 2 and Visit 3 Safety endpoints (SEP) 1: Adverse events (type, frequency, severity, seriousness, causal relationship to IMD / IMP) 2: Change in vital signs at Visit 2 and Visit 3 each compared to Visit 1 3: Investigator’s and subject’s global judgement on tolerability at Visit 2 and Visit 3 4: Percentage of subjects with co-medication at Visit 2 and Visit 3 each compared to Vis	—

Measure

Time frame

Secondary end point(s): Definitions: - CLINICAL CURE is defined as ACSS-“Typical” domain score =4 (sum of the 6 scores within the domain) whereby items 1-5 must be scored “1” (mild) or “0” (not present), and item 6 must be scored “0” (absence of haematuria, i.e. no visible blood in urine). - A positive urine culture is defined as either =10^3 CFU/mL of culture (with a maximum of 2 species) of uropathogens, or a positive mixed urine culture =10^3 CFU/mL as defined by the MIQ 02/2020 guidance. - A negative urine culture is defined as 1 on Day 8 6: Percentage of subjects with recurrence of UTI established by ACSS-“Typical” domain score =6 during the follow-up phase 7: Percentage of subjects with antibiotic therapy for acute UTI in the acute phase (Visit 1 – Visit 2, in addition to the trial treatment), in the follow-up phase (Visit 2 – Visit 3: recurrence by antibiotic therapy), and in both trial phases (Visit 1 – Visit 3) 8: Time to recurrence of UTI as determined by the first date of the ACSS-“Typical” domain score =6 during the follow-up phase 9: Time to recurrence of UTI as determined by the first date of antibiotic use for acute UTI during the follow-up phase 10: Change in ACSS-“Typical” domain score on Day 8 compared to Visit 1 11: Change in ACSS-“QoL” domain score on Day 4 and Day 8 each compared to Visit 1 12: Change in the total score calculated as the sum of the two domain scores ACSS-“Typical” and ACSS-“QoL” on Day 8 compared to Visit 1 13: Change in time course of the ACSS-“Dynamic” domain score from Day 1 to Day 8 14: Investigator’s and subject’s global judgement on efficacy at Visit 2 and Visit 3 Safety endpoints (SEP) 1: Adverse events (type, frequency, severity, seriousness, causal relationship to IMD / IMP) 2: Change in vital signs at Visit 2 and Visit 3 each compared to Visit 1 3: Investigator’s and subject’s global judgement on tolerability at Visit 2 and Visit 3 4: Percentage of subjects with co-medication at Visit 2 and Visit 3 each compared to Vis

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Countries

Germany

Contacts

Public ContactGlobal Clinical Operations

MCM Klosterfrau Vertriebsgesellschaft mbH

Ingrid.Schwienhorst@klosterfrau.de+492211652 949

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026