The DEVA trial: protocol for a randomised controlled trial of dequalinium chloride versus usual care antibiotics for the treatment of bacterial vaginosis.

BACKGROUND: Bacterial vaginosis (BV) is the most common cause of vaginal discharge in women of reproductive age, and it is estimated that up to a third of women will experience it at some point in their lives. BV produces an offensive vaginal odour and it is associated with serious sequelae. The most frequently prescribed treatment for BV in the UK is 7-day oral metronidazole but recurrences are common following it. Dequalinium chloride (Fluomizin©) is an anti-infective, antiseptic agent administered as a vaginal tablet. Small studies have shown this to be an effective alternative to antibiotics as a BV treatment. This trial aims to investigate whether dequalinium is as effective as current antibiotic treatments for the treatment of BV 1 month after treatment start. METHODS: DEVA is a multi-centre, randomised, open-label, parallel group, non-inferiority trial of dequalinium chloride versus usual care antibiotics for the treatment of BV. Recruitment will take place in 15 GUM clinics in the UK with Leeds Sexual Health also managing remote recruitment via the trial website. Women will be randomised 1:1 to receive dequalinium or usual care antibiotics. The primary outcome is to determine if the proportion of women reporting resolution of BV symptoms 4 weeks after treatment (without the need for additional treatment) is not worse in women treated with dequalinium chloride compared to usual care antibiotics. Questionnaire follow-up will take place 4 and 12 weeks after starting treatment, and remotely recruited patients will also provide a week 4 BV vaginal smear. The sample size is 904. DISCUSSION: This trial will provide high-quality evidence on the use of dequalinium chloride as a BV treatment, which could result in patients reducing the number of antibiotics they take. TRIAL REGISTRATION: ISRCTN ISRCTN91800263. Prospectively registered on 20 January 2020.

Dequalinium for bacterial vaginosis.

Bacterial vaginosis is an infection characterised by overgrowth of anaerobic bacteria in the vagina with an accompanying loss of lactobacilli, and is thought to be the most common cause of abnormal vaginal discharge in women of child-bearing age.1 Standard treatment for symptomatic bacterial vaginosis consists of a short course of an oral or topical antibiotic.2 Dequalinium, a topical antiseptic agent, has been available for many years as a treatment for oral infections.3 A new formulation, dequalinium 10mg vaginal tablets (Fluomizin-Kora Healthcare), was licensed in the UK in June 2015 for the treatment of bacterial vaginosis.4 Here, we review evidence for the effectiveness and safety of dequalinium vaginal tablets in the management of bacterial vaginosis.

[The application of laripront in the pediatric otorhinolaryngological practice].

The objective of the present study was to estimate the efficacy of laripront intended for the treatment of inflammatory diseases of the laryngopharynx in the children. Available for the observation were 50 patients aged between 4 and 14 years suffering from the following ENT pathologies: adenoiditis, lacunar tonsillitis, acute laryngitis, chronic tonsillitis, oropharyngeal candidiasis, chronic hypertrophic pharyngitis, atrophic pharyngolaryngitis after the chemical burn of the mouse cavity and laryngopharynx or in the case of gastroesophageal reflux disease. All the patients enjoyed the positive outcome of the treatment that was especially efficacions in the patients with acute pathologies. No adverse effects of the treatment were documented.

A comparison of dequalinium chloride vaginal tablets (Fluomizin®) and clindamycin vaginal cream in the treatment of bacterial vaginosis: a single-blind, randomized clinical trial of efficacy and safety.

AIMS: To investigate if vaginal application of dequalinium chloride (DQC, Fluomizin®) is as effective as vaginal clindamycin (CLM) in the treatment of bacterial vaginosis (BV). METHODS: This was a multinational, multicenter, single-blind, randomized trial in 15 centers, including 321 women. They were randomized to either vaginal DQC tablets or vaginal CLM cream. Follow-up visits were 1 week and 1 month after treatment. Clinical cure based on Amsel's criteria was the primary outcome. Secondary outcomes were rate of treatment failures and recurrences, incidence of post-treatment vulvovaginal candidosis (VVC), lactobacillary grade (LBG), total symptom score (TSC), and safety. RESULTS: Cure rates with DQC (C1: 81.5%, C2: 79.5%) were as high as with CLM (C1: 78.4%, C2: 77.6%). Thus, the treatment with DQC had equal efficacy as CLM cream. A trend to less common post-treatment VVC in the DQC-treated women was observed (DQC: 2.5%, CLM: 7.7%; p = 0.06). Both treatments were well tolerated with no serious adverse events occurring. CONCLUSION: Vaginal DQC has been shown to be equally effective as CLM cream, to be well tolerated with no systemic safety concerns, and is therefore a valid alternative therapy for women with BV [ClinicalTrials.gov, Med380104, NCT01125410].

[The treatment of MRSA colonized middle ear; case report and literature review]. / Die Behandlung des MRSA besiedelten Mittelohres; eine Fallbeschreibung und Literaturübersicht.

BACKGROUND: The treatment of MRSA (methocillin resistant staphylococcus aureus) colonized middle ear is difficult. According to the guidelines, a MRSA colonized Patient is not to be treated with systemic antibiotics. The topical treatment shows the problem of the ototoxicity of most of the used antiseptic as well as antibiotic substances. METHOD: Selective literature review and consideration of the author's own clinical experience. RESULTS AND CONCLUSIONS: Antibiotic treatment options include aequeous Tetracyclin drops, aequeous chloramphenicol drops and quinolon ear drops (unfortunately the MRSA is resistent mostly). Antiseptics without ototoxic effects are the Burow's solution, Povidone-iode, acetic acid solutions and aequeous dequalinium solutions.

Local treatment of vaginal infections of varying etiology with dequalinium chloride or povidone iodine. A randomised, double-blind, active-controlled, multicentric clinical study.

This randomised, double-blind, multicentric clinical study compared the efficacy and tolerability of the two vaginal antiseptics, 10 mg dequalinium chloride (CAS 522-51-0, Fluomycin N) and 200 mg povidone iodine (CAS 25655-41-8), in a parallel-group design. A total of 180 patients with vaginal infections of varying etiology participated in this study (bacterial vaginosis, fluor vaginalis, vulvo-vaginal candidiasis, trichomoniasis). Patients were randomly allocated to one of the two treatment groups and were treated once per day for 6 days. Control examinations took place 5 to 7 days after the end of treatment, and 3 to 4 weeks after the first control examination. The total symptoms score, a summary score for the clinical symptoms, discharge, burning, pruritus, redness of vulva/vagina, was defined as primary efficacy parameter. The treatments at the first control examination were compared in the full analysis set using the Wilcoxon-Mann-Whitney U-test, 2-sided, thereby proving equivalence of both treatments at the 5% level. Both treatments strongly improved the symptoms of vaginal infections both on short-term and long-term follow-up. Descriptive analysis of the secondary parameters, vaginal pH, degree of purity of the vaginal flora, and number of lactobacilli in the wet mounts, supported the comparable efficacy of both therapies to restore the vaginal milieu. Analysis of the diagnostic subgroups indicated that irrespective of the diagnosis, both treatments improved the efficacy criteria as observed for the entire population. The global assessment of the therapeutic efficacy by investigators and patients supported the results of the efficacy analysis with good to very good ratings in 70-90% of the cases. A good tolerability of both preparations was observed in this study with a low number of adverse events in the test group (5.8%).

Microvascular response to local application of dequalinium chloride. A vital microscopical study of hamster's cheek pouch and a microangiographic study of rabbit's ear.

Dequalinium chloride is a topical antiseptic, whose use may be attended by skin necrosis. Since microcirculatory changes are an early and distinct manifestation of tissue injury, the tissue damaging effect of dequalinium chloride on the microcirculation was examined. The immediate vascular reactions were studied by vital microscopy, of the hamster cheek pouch and the late effects were visualized by microangiography of the rabbit ear. An aqueous solution of dequalinium chloride in concentrations well below those used in clinical practice induced severe microcirculatory disturbances.