Study to evaluate the microbial response of Furazidin 200 mg prolonged-release tablets in urine collected in patients with clinical symptoms of lower urinary tract infections, and to gain a better understanding of the drug metabolism in patients.

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: EUCTR2021-000963-54-PL
• Lead Sponsor: Adamed Pharma S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-07
• Last Update Posted: 15 November 2021

Recruitment & Eligibility

• Status: A
• Sex: Female
• Target Recruitment: 100

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. For patients < 18 years old – parents’ informed
consent is required.
2. Age: Subject must be = 12 years of age at the time of signing the informed consent form.
3. Sex: female.
4. Patients with diagnosis of uncomplicated lower urinary tract infection (acute or recurrent). For the
purposes of this study, urinary tract infection 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 systemic antibiotics and/ or chemotherapeutic agents for any reason within
7 days prior to Visit 1; NOTE: in case of any antimicrobial therapy administrated > 7 days before
Visit 1, each treatment should be evaluated individually by the Investigator to assess the risk of PK
or PD carryover from previous antibiotics/ chemotherapeutic agents.
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 ovariectomy or
hysterectomy), abstain from sexual intercourse 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
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? yes
Number of subjects for this age range: 12
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 76
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 12

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. Travelled and stayed more than 48 hours in the country affected with SARS-CoV-2 transmission
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 duringthe 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. Known contraindications for furazidin treatment: severe pulmonary disease, diagnosed
polyneuropathy, e.g., diabetic polyneuropathy, known glucose-6-phosphate dehydrogenase
deficiency, anemia, known deficiency of vitamins B and folic acid, fructose intolerance, glucosegalactose malabsorption or sucrase-isomaltase deficiency.
8. 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; NOTE: Patients with mild
to moderate renal impairment may be enrolled into the study, unless in Investigator’s opinion,
patient will not be able to attend the study visits.
9. Any intake of systemic bacteriostatic agents within 7 days prior to Visit 1 and 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, with an exemption for acetylosalicylic
acid at a stable dose of 75 mg or 150 mg per day, taken over 30 days before Visit 1 to reduce blood
clotting; NOTE in case of any bacteriostatic therapy administrated > 7 days before Visit 1, each
treatment should be evaluated individually by the Investigator to assess the risk of PK or PD
carryover.
10. Other acute infections (except for acute UTI) requiring antibiotic treatment at Visit 1.
11. Catheter in the bladder or any other foreign body in the urinary tracts.
12. Overactive bladder.
13. Menstrual bleeding at the day of visit.
14. Immunomodulatory prophylaxis due to urinary tract infection within 6 months prior to Visit 1;
15. The presence of known severe renal impairment (glomerular filtration rate < 30 ml/min).
16. Current or previous history of addiction to alcohol and/or drugs.
17. Patients who are expected to have problems with the insertion of intravenous catheters or
venipuncture.
18. 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.
19. The legal inability and/or other circumstances that prevent the patient's understanding of the extent
and possible influence of the study.
20. Sound suspicion that the patient fails to co

Study & Design

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