Furazidin for resolution or improvement of all clinical symptoms of Urinary Tract Infections

Phase 1

• Conditions: uncomplicated lower urinary tract infections (acute or recurrent); MedDRA version: 20.0Level: HLTClassification code 10046577Term: Urinary tract infectionsSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 20.0Level: PTClassification code 10046571Term: Urinary tract infectionSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 20.0Level: LLTClassification code 10024981Term: Lower urinary tract infectionSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 20.0Level: LLTClassification code 10038140Term: Recurrent 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: EUCTR2020-005559-19-HU
• Lead Sponsor: ADAMED Pharma S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-16
• Last Update Posted: 15 January 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 636

Inclusion Criteria

Inclusion criteria
The patients meeting the below mentioned criteria will be included into the study:
1. Informed Consent: Willingness to comply with all the study activities and procedures and
provision of signed and dated, written informed consent form prior to any mandatory study
specific procedures, sampling, and analyses.
2. Age: Subject must be = 18 < 65 years of age at the time of signing the informed consent
form.
3. Sex: female.
4. Patients with diagnosis of the acute or recurrent uncomplicated lower urinary tract infection
(cystitis). For the purposes of this study, urinary tract infection (cystitis) is defined by:
a) presence of at least two of the following clinical symptoms: dysuria, urinary
frequency, urinary urgency, suprapubic pain,
and
b) at least a score of 6 of typical symptoms obtained by the Acute Cystitis Symptom
Score (ACSS) questionnaire applied as additional tool for the clinical inclusion criteria
defined by the draft guideline on the evaluation of medicinal products indicated for
treatment of bacterial infections (EMA/844951/2018 Rev. 3)
and
c) presence of pyuria, as determined by a dipstick test positive for leukocyte esterase or
at least 10 leukocytes per cubic millimeter (WBC = 10/mm3) as required by the draft
EMA Guideline (EMA/844951/2018 Rev. 3).
5. Onset of symptoms of urinary tract infection at least 12 hours but not more than 72h prior
to Visit 1 (Screening).
6. No prior treatment with antibiotics and/ or chemotherapeutic agents for any reason within 7
days prior to Visit 1.
7. Negative urine pregnancy test for female subjects of childbearing potential.
8. Female patients must be post-menopausal (i.e.: no menstrual bleeding for at least 12
consecutive months), surgically sterile (i.e. after surgery as bilateral tubal ligation, bilateral
ovarectomy or hysterectomy), or using an acceptable and effective method of contraception
(an acceptable method of contraception is defined as a barrier method in conjunction with a
spermicide) for the duration of the study and for 1 month after the last dose of Furazidin
PR or Nitrofurantoin PR to prevent pregnancy. In addition, oral contraceptives, approved
contraceptive implant, long-term injectable contraception, intrauterine device, or tubal
ligation are allowed. Oral contraception alone is not acceptable; additional barrier methods
in conjunction with spermicide must be used.
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 636
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients must not meet any of the following exclusion criteria:
1. Symptoms suggesting probability of SARS-CoV-2 infection.
2. Direct contact with a person suffering from COVID-19 within 14 days before Visit 1.
3. Traveled and stayed in the country affected with SARS-CoV-2 transmition within 14 days
before Visit 1.
4. Any symptoms of complicated urinary tract infections (cUTI), pyelonephritis (i.e. fever T
= 38.0°C, flank pain (costovertebral angle pain), chills and / or inflammation of the vulva
and vagina and / or abnormal discharge from the vagina or urethra at Visit 1.
5. Clinically significant anatomic and functional disorders of the urinary tracts (including,
but not limited to: congenital malformations, conditions after surgery within the urogenital
tracts during the last 30 days, clinically significant residual urine (more than 100 ml of
urine being retained in urinary bladder based on PVR USG examination*), neurogenic
bladder, urolithiasis, urogenital system malignancies) allowing to recognize complicated
urinary tract infection.
6. Recurrent urinary tract infections (more than 3 episodes of infection during the last year),
if there was an acute episode during the last 4 weeks.
7. As judged by the investigator, any evidence of disease/condition which in the
investigator’s opinion makes it undesirable for the subject to participate in the trial.
8. Any intake of bacteriostatic agents, OTC drugs, including ibuprofen and other NSAIDs,
and / or dietary supplements, food preparations used in the urinary tract infections, within
7 days prior to Visit 1.
9. Other acute infections (with the exception of acute UTI) requiring antibiotic treatment at
Visit 1.
10. Catheter in the bladder or any other foreign body in the urinary tracts.
11. Overactive bladder.
12. Menstrual bleeding at the day of visit.
13. Immunomodulatory prophylaxis due to urinary tract infection within 6 months prior to
Visit 1.
14. Treatment with vitamin K antagonists (Warfarin, Acenocumarol) as long the INR test is
out of the normal values resulting in significant haematuria, probenecid, sulfinpirazon,
alkalising drugs containing magnesium trisilicate, any antibiotics / bacteriostatic drugs,
ristomycin, metoclopramide, nalidixic acid, atropine, levomicetin, sulphanilamide.
15. Pregnancy or lactation.
16. The presence of known severe renal impairment (creatinine clearance glomerular filtration
rate < 30 ml/min/1.73m2).
17. The presence of: polycystic kidney disease, severe pulmonary disease, diagnosed
polyneuropathy, e.g. diabetic polyneuropathy, known glucose-6-phosphate
dehydrogenase deficiency, anemia, known deficiency of vitamins B and folic acid,
neutropenia, severe thrombocytopenia, liver failure, porphyria, immunosuppressive or immunomodulatory treatment, HIV/AIDS infection, chemotherapy, steroid therapy,
fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency –
data obtained on the basis of patient medical history.
18. The known history of cancer disease, that is not cured nor stable within 12 months prior
to Visit 1.
19. Active peptic ulcers.
20. Current or previous history of addiction to alcohol and/or drugs.
21. Investigator’s opinion that the patient should not participate in the study if the subject is
unlikely to comply with study procedures, restrictions and requirements:
22. The legal inability and/or other circumstances that prevent the patient's understanding of
the extent and possible influence of the study.
23. Sound

Study & Design

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