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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Bacterial Vaginosis, Vaginal Infection, Vaginal Diseases

Intervention / Treatment
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* Drug: Dequalinium Chloride
* Drug: Metronidazole Oral


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Premenopausal woman ≥18 years Diagnosis of bacterial vaginosis (all 4 Amsel criteria positive, i.e. 1) greyish white thin discharge, 2) KOH test or 'fishy' smell, 3) microscopic presence of > 20% clue cells, 4) vaginal pH > 4.5) Signed Written Informed Consent to participate in this study Exclusion Criteria: Pregnancy and/or lactation based on urine Pregnancy test (women with childbearing potential should use any contraception excluding vaginal methods like vaginal ring, etc.) Uterine bleeding (including menstruation) or vaginal bleeding of unknown origin Ulcerations/erosions of vaginal mucosa or cervix uteri Patients with clinical symptoms and findings of Candida vulvovaginitis and/or Aerobic vaginitis Clinically manifest or suspicion of STIs (Neisseria gonorrhoeae, Chlamydia trachomatis, or Trichomonas vaginalis) based on signs, symptoms, and anamnesis Use of any antimicrobial treatment (local or systemic) 14 days before entry the study Use of any vaginal medication or vaginal douching 7 days before entry the study Unwillingness to refrain from alcohol consumption during treatment, and 48 hours after treatment Severe systemic diseases (HIV, cancer, tuberculosis, autoimmune diseases, diabetes mellitus, severe psychiatric conditions, etc.), including diseases treated with immunosuppressive therapies, systemic corticosteroids, or warfarin Known or suspected hypersensitivity to one of the study medications, inclusive of their excipients 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) Participation of patient in another investigational drug study concomitantly or within 30 days prior to entry in the study Patient is relative of, or staff directly reporting to, the investigator

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dequalinium chloride<br>Dequalinium chloride 10 mg vaginal tablets | Drug: Dequalinium Chloride<br>* Fluomizin vaginal tablets (10 mg dequalinium chloride) used once a day for 6 days<br>* Other names: Fluomizin;|
| Active Comparator: Metronidazole<br>Metronidazole 500 mg oral tablets | Drug: Metronidazole Oral<br>* Metronidazole oral tablets (500 mg) taken twice a day for 7 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical cure rate | Resolution of the abnormal vaginal discharge, negative whiff test, and less than 20% clue cells | One week after randomization (C1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical cure rate | Resolution of the abnormal vaginal discharge, negative whiff test, and less than 20% clue cells | One month after randomization (C2) | 
| Bacteriological cure rate | Nugent score ≤3 | One week & one month | 
| Therapeutic cure | Combination of clinical and bacteriological cures, | One week & one month | 
| Individual Amsel Criteria over time | greyish white thin discharge Whiff test: 'fishy' smell with 10% KOH > 20% clue cells in saline wet mount vaginal pH > 4.5 | One week & one month | 
| Nugent score over time | 0-3: normal flora 4-6: intermediate flora 7-10: bacterial vaginosis | One week & one month | 
| Subjective assessment of efficacy | Efficacy was assessed by patients and investigators as 'very good', good, moderare or 'poor'. Patient satisfaction with the treatment ranged from 'very satisfied' to 'not satisfied' | One week & one month | 
| Subjective assessment of tolerability | Tolerability was assessed by patients and investigators as 'very good', good, moderare or 'poor'. Patient satisfaction with the treatment ranged from 'very satisfied' to 'not satisfied' | One week & one month | 
| Adverse events |  | Up to end of study (one month) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bacterial vaginosis, dequalinium chloride, metronidazole, vaginal infection treatment, comparative study, non inferiority