Individualized homeopathy to reduce the use of antibiotics in women with recurring uncomplicated urinary tract infections

Phase 1

• Conditions: Women with recurring uncomplicated urinary tract infections; MedDRA version: 20.0Level: LLTClassification code 10021872Term: Infection urinary tractSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2021-002214-14-DE
• Lead Sponsor: Klinikum rechts der Isar, Technische Universität München

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-15
• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 240

Inclusion Criteria

1.Females, age <65 years
2.Signed informed consent
3.Documented recurrent UTI (i.e. = 2 UTI in 6 months and/ or = 3 UTI in 12 months)
4.No change of other prophylactic treatment (e.g. Urovaxom, estrogen) for recurrent UTI for at least three months before baseline
5.No product or dosage change of systemic hormonal treatment (including oral anticonception) for at least three months before baseline
6.Female participants who are not capable of bearing children or who use a method of contraception that is medically approved by the health authority of the respective country.

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 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

1.Individual symptomatology of the patient indicates the prescription of
a HMP which is not available within this clinical trial
2.Pregnancy or breast feeding after pregnancy
3.Women with a complicated urinary tract infection (including infections
occurring due to anatomical abnormalities (e.g. an obstruction, renal
tract calculi, hydro nephrosis), infections occurring due to an immune
compromised state (e.g. HIV, immune suppressive therapy), and
recurrent infections despite adequate treatment (multi-drug resistant
organisms or atypical organisms))
4.Surgery of the urinary tract or the pelvic floor
5.Known hypersensivity against the study medication or the
recommended on demand medication (Ibuprofen)
6.Homoeopathic therapy for recurrent UTIs during the last 3 months
before baseline
7.Postmenopausal woman WITHOUT previous attempt of a therapy
with locally applicate (vaginal) oestrogen
8.Serious acute or chronic organic disease or serious mental disorder,
including
-diseases requiring immune suppressive therapy
-diabetes mellitus type 1 or 2 with an HbA1c > 7%
-any acute organic failure
-any advanced chronic organic failure (e.g. grade 3 or more)
-active cancer
-active (=clinically unstable) epileptic, cardiovascular or other organic
pathology
9.Patients not able to declare meaningful informed consent on their own
(e.g. with legal guardian), or other vulnerable patients (e.g. under
arrest)
10.Simultaneous participation in any other clinical trial
11.Employees or family members of the sponsor or investigators

Study & Design

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