Comparison of Dequalinium Chloride (Fluomizin) vs Oral Metronidazole for the Treatment of Bacterial Vaginosis

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.

• Dequalinium Chloride (Drug), also known as Fluomizin: Fluomizin vaginal tablets (10 mg dequalinium chloride) used once a day for 6 days
• Metronidazole Oral (Drug): Metronidazole oral tablets (500 mg) taken twice a day for 7 days

Primary outcomes

• Clinical Cure Rate [One week after randomization (C1)]: Resolution of the abnormal vaginal discharge, negative whiff test, and less than 20% clue cells

Secondary outcomes

• Clinical Cure Rate [One month after randomization (C2)]: Resolution of the abnormal vaginal discharge, negative whiff test, and less than 20% clue cells
• Bacteriological Cure Rate [One week & one month]: Nugent score ≤3 Nugent score uses a 0 - 10 scale (higher score mean a worse outcome): 0 - 3 = normal flora, 4 - 6 = intermediate flora, 7 - 10 = bacterial vaginosis
• Therapeutic Cure [One week & one month]: Combination of clinical and bacteriological cure
• Subjective Assessment of Efficacy [One week]: Efficacy was assessed by patients and investigators as 'very good', 'good', 'moderate' or 'poor'.
• Subjective Assessment of Tolerability [One week]: Tolerability was assessed by patients as 'very good', 'good', 'moderate' or 'poor'.

Sex: Female, ages: 18 Years to any

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

Participant flow

Outcome results

• Clinical Cure Rate (Primary), Count of participants, Participants: Dequalinium Chloride 64; Metronidazole 69 (p <.025)
• Clinical Cure Rate (Secondary), Number, participants: Dequalinium Chloride 55; Metronidazole 62
• Bacteriological Cure Rate (Secondary), Count of participants, Participants: Dequalinium Chloride 35; Metronidazole 51
• Therapeutic Cure (Secondary), Count of participants, Participants: Dequalinium Chloride 34; Metronidazole 48
• Subjective Assessment of Efficacy (Secondary), Count of participants, Participants: Dequalinium Chloride 46; Metronidazole 49
• Subjective Assessment of Tolerability (Secondary), Count of participants, Participants: Dequalinium Chloride 30; Metronidazole 21
• Patients Cured Based on Standard Amsel Criteria (Post hoc), Count of participants, Participants: Dequalinium Chloride 68; Metronidazole 73

Adverse events

Time frame: 1 month

Other adverse events by term

• Results publication: 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. PMID 38696172

• Study Protocol and Statistical Analysis Plan (PDF, 2022-04-13)

• Philipp Grob, PhD, Study director, Medinova AG