Clinical trial NCT05788991: Comparison of Dequalinium Chloride (Fluomizin) vs Oral Metronidazole for the Treatment of Bacterial Vaginosis
Official title: Comparative Study of the Efficacy and Safety of Vaginally Applied Dequalinium Chloride (10 mg) and Orally Applied Metronidazole (2 x 500 mg) in the Treatment of Bacterial Vaginosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Bacterial Vaginosis
Vaginal Infection
Vaginal Diseases
Keywords: bacterial vaginosis
dequalinium chloride
metronidazole
vaginal infection treatment
comparative study
non inferiority
Lead sponsor: Medinova AG
Sponsor class: INDUSTRY
First posted: 2023-03-29
Enrollment: 151
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to show the efficacy and safety of dequalinium chloride in the treatment of bacterial vaginosis compared to metronidazole.

Detailed description: Eligible patients who signed informed consent were randomized to receive treatment with either dequalinium chloride (+ oral placebo) or metronidazole (+ vaginal placebo) for up to 7 days. Primary objective was clinical cure rate at one week after start of treatment. Control visits to assess outcomes were done after end of treatment and after one month.

Eligibility criteria: Inclusion Criteria:

1. Premenopausal woman ≥18 years
2. Diagnosis of bacterial vaginosis (all 4 Amsel criteria positive, i.e. 1) greyish white thin discharge, 2) postassium hydroxide (KOH) test or 'fishy' smell, 3) microscopic presence of \> 20% clue cells, 4) vaginal pH \> 4.5)
3. Signed Written Informed Consent to participate in this study

Exclusion Criteria:

1. Pregnancy and/or lactation based on urine Pregnancy test (women with childbearing potential should use any contraception excluding vaginal methods like vaginal ring, etc.)
2. Uterine bleeding (including menstruation) or vaginal bleeding of unknown origin
3. Ulcerations/erosions of vaginal mucosa or cervix uteri
4. Patients with clinical symptoms and findings of Candida vulvovaginitis and/or Aerobic vaginitis
5. Clinically manifest or suspicion of sexually transmitted infections (Neisseria gonorrhoeae, Chlamydia trachomatis, or Trichomonas vaginalis) based on signs, symptoms, and anamnesis
6. Use of any antimicrobial treatment (local or systemic) 14 days before entry the study
7. Use of any vaginal medication or vaginal douching 7 days before entry the study
8. Unwillingness to refrain from alcohol consumption during treatment, and 48 hours after treatment
9. Severe systemic diseases (HIV, cancer, tuberculosis, autoimmune diseases, diabetes mellitus, severe psychiatric conditions, etc.), including diseases treated with immunosuppressive therapies, systemic corticosteroids, or warfarin
10. Known or suspected hypersensitivity to one of the study medications, inclusive of their excipients
11. Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant (including inability to fill-in electronic patient diary)
12. Participation of patient in another investigational drug study concomitantly or within 30 days prior to entry in the study
13. Patient is relative of, or staff directly reporting to, the investigator

Primary outcomes:
measure: Clinical Cure Rate
timeFrame: One week after randomization (C1)
Secondary outcomes:
measure: Clinical Cure Rate
timeFrame: One month after randomization (C2)
measure: Bacteriological Cure Rate
timeFrame: One week & one month
measure: Therapeutic Cure
timeFrame: One week & one month
measure: Subjective Assessment of Efficacy
timeFrame: One week
measure: Subjective Assessment of Tolerability
timeFrame: One week
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: Centrum ambulantní gynekologie a primární péče, s.r.o.
city: Olomouc
country: Czechia
facility: G-CENTRUM Olomouc s.r.o.
city: Vsetín
country: Czechia
facility: GYNEKO spol. s r.o
city: Ústí nad Labem
country: Czechia
facility: Gynekologicko-porodnická ambulance
city: Lublin
country: Poland
facility: 1 Wojskowy Szpital Kliniczny z Polikliniką SPZOZ
city: Lublin
country: Poland
facility: KO-MED CENTRA KLINICZNE Sp. z o.o. Ośrodek
city: Łódź
country: Poland
facility: Salve Medica Sp. z o. o. S. K.
city: Łódź
country: Poland
facility: NZOZ All-Med Centrum Medyczne
city: Żurawica
country: Poland
facility: Prywatny Gabinet Ginekologiczno-Położniczy
city: Bratislava
country: Slovakia
facility: GPN, s.r.o.
city: Bratislava
country: Slovakia
facility: RADMA GYN s.r.o.
city: Dubnica nad Vahom
country: Slovakia
facility: GYNEDUR s.r.o
city: Dubnica Nad Váhom
country: Slovakia
facility: MCM GYNPED s.r.o.
city: Puchov
country: Slovakia
facility: GYNECARE s.r.o.
Study officials:
affiliation: Medinova AG
name: Philipp Grob, PhD
role: STUDY_DIRECTOR
References:
citation: Raba G, Durkech A, Malik T, Bassfeld D, Grob P, Hurtado-Chong A; Fluomizin Study Group. Efficacy of Dequalinium Chloride vs Metronidazole for the Treatment of Bacterial Vaginosis: A Randomized Clinical Trial. JAMA Netw Open. 2024 May 1;7(5):e248661. doi: 10.1001/jamanetworkopen.2024.8661.