Active clinical trials for "Candidiasis, Vulvovaginal"

Vaginitis is one of the most common gynecological problems in women. Candida albicans is responsible for more than 85% of vaginal fungal infections and reinfection after standard treatment is quite common. The aim of this study is to compare the effects of a zinc-containing vaginal gel and oral fluconazole on the treatment and recurrence of vulvovaginal candidiasis (VVC). The investigator's hypothesis is that zinc-containing vaginal gel may decrease the rate of reinfection after standard treatment with oral 150 mg fluconazole.

This is a multi-centre, multi-national study to evaluate the clinical performance and safety of treatment with Gedea Pessary in adult women with confirmed VVC. The study population will consist of post-menarchal, pre-menopausal females, 18 years or older, seeking care for VVC symptoms. A total of 26 patients are planned to be included in the study. On Day 0 (Screening, Visit 1), eligible patients will undergo a gynaecological examination, including collection of CVVS data, and vaginal samples. Patients will be provided with 6 doses of Gedea Pessary that will be self-administered as a daily treatment (Days 0 to 5). Patients will visit the clinic on Day 7 (+2 days, Visit 2) for gynaecological examinations, including collection of CVVS data for the assessment of clinical cure and reporting of AEs and concomitant medications. On Day 14 (±2 days, Visit 3), patients that did not have a clinical and mycological cure Day 7 will re-visit the clinic for additional gynaecological examinations, including collection of CVVS data for the assessment of clinical cure. Rescue treatment will be offered during visits 2 and 3, if necessary. Patients will have a final telephone follow-up on Day 25 (±3 days, Visit 4), for for reporting of AEs, concomitant medications and potential menstruation onset. Vaginal sampling for culture and sequencing, as well as vaginal pH measuremetnts will be performed at the clinic on Day 0, Day 7, and Day 14. On Day 25, patients will self-perform vaginal swabs at home for sequencing and vaginal culture. Patient questionnaires for assessing VVC symptoms, will be used during the treatment period (Days 0 to 5), 1 day after the treatment (Day 6) and on Days 11 and 25. Usability will be assessed on Day 7, also via the patient questionaire. The patient questionnaire will be based on an electronic patient reported outcomes (ePRO) system, i.e. a mobile application (ViedocMe™).

Vulvovaginal candidiasis (CVV) is an infectious process of the female genitourinary tract, an important health issue due to the high incidence and difficulties encountered in the treatment. Therefore, new therapeutic modalities are sought with the capacity to minimize drug side-effects and to reduce recurrent cases. The objective of this stufy is to evaluate the clinical and microbiological response of the 405 nm blue light emitting diode in the treatment of women with vulvovaginal candidiasis and in women with healthy gentourine treatment. A clinical trial was conducted involving 40 women, divided into two groups, the first group consisting of women with a confirmed CVV diagnosis and a second group formed by women with a healthy genitourinary tract, without symptoms and symptoms of the disease. Both groups underwent clinical evaluation and examination with endocervice collection with gynecologist before and after a session of application of the Blue Light Emitting Diode of 405 nm, lasting 4.5 minutes. There will also be an evaluation of the effects of the diary through the questionnaire answered before and after the participants' treatment. It is expected that the 405 nm blue LED will destroy the CVV fungus demonstrated by laboratory examination and also improve the signs and results analyzed by the gynecologist and participants.

The overall aim of this study is to investigate if vaginally applied 1% chlorhexidine gluconate (CHG) could be an alternative treatment to oral fluconazole (FLZ), both during an acute episode and as prophylaxis, against recurrent infections of vulvovaginal candidiasis (RVVC). RVVC is very common in fertile women. Up to six months of treatment with FLZ is recommended for RVVC. Over the last ten years, the use of FLZ has increased markedly in many countries. No major problems have been noted with resistance development, but there is concern that this will occur in the future and alternative treatments are requested. In recent years, it has emerged that flukonazol interacts with several different types of drugs that are common in the patient group; several antidepressants, pain relief at dysmenorrhea (NSAID) and oral contraceptives to name a few. In Sweden an over-the-counter vaginal cream consisting of 1% chlorhexidine gluconate (Hibitane®) is available with the indication antiseptic use in vaginal examinations, especially during childbirth. The product has been used for a long time in various gynecological and obstetric surgical procedures. Hibitane® is approved during pregnancy and the cream is usually well tolerated. The research group has previously done an in vitro study in which we analyzed the effect of FLZ and CHG's ability to kill fungal cells and to break down existing biofilm or prevent new biofilm formation. The biofilm formation is an important stage for the fungal cells to attach to surfaces such as skin and mucosa and is considered a first step in the development of an infection. In the biofilm, the fungus can hide from the immune system and also to some extent for various treatments aimed against the fungus. The results of the study showed that CHG was better than FLZ both at killing the fungal cells and preventing new biofilm from forming and dissolving already established "old" biofilm. This effect is absolutely crucial for successful treatment with antimycotics. These encouraging results form the basis of the planned study. If CHG is at least as effective as FLZ with little impact on vaginal lactobacillus, with high tolerability and without cytotoxic effect on epithelial cells, the results of the study might lead to major benefits to the patients with reduced risk of systemic side effects such as drug interactions, development of drug resistance and reduced drug costs.

The aim of the study is to investigate the efficacy of Fluconazol versus L-Mesitran in the treatment of patients with recurrent vulvovaginal candidiasis. Vaginal swabs will be analyzed after 1, 6 and 12 months. The study ends after 252 included patients completed the study.

This study is a multicentre, three-arm, double-blind, randomized controlled, parallel-group, comparative phase II clinical trial to evaluate miconazole nitrate 2% + domiphen bromide vaginal cream in subjects with acute vulvovaginal candidiasis.

We are trying to determine if Clotrimazole vaginal tablets with oral Lactobacillus is better than Clotrimazole vaginal tablets in Preventing the Recurrence of vulvovaginalcandidiasis

With the knowledge that VVC is an infectious disease of the genitourinary tract that is common in women of reproductive age, and because of the shortage of non-drug therapies for this condition, this study will aim to evaluate the effect of ultraviolet A/blue LED with a wavelength of 401 ± 5 nm in patients with a clinical manifestation of candidiasis and its ability to prevent recurrence.

This project aims to investigate if the contraceptive method, Phexxi, causes changes to the composition of the vaginal microbiome. The investigators hypothesize that regular use of Phexxi will cause increased colonization of lactic acid-producing lactobacilli, which could have positive effects in the way of preventing recurrent episodes of BV and candida infections.

Self-care and self-medication are commonly the treatments of choice for the management of minor ailments. Minor ailments can be treated through community pharmacy using a Minor Ailment Service (MAS). The INDICA+PRO Impact Study, evaluated the clinical, economic and humanistic impact of a MAS, concluding that community pharmacies could greatly benefit the health system. Thus, the following objectives were defined for the INDICA+PRO implementation study. The primary objective is to implement a standardised MAS in usual practice in community pharmacy in Spain. The secondary objectives include an evaluation of the clinical and economic outcomes and the role and impact of two different models of change agents. A pragmatic study with an effectiveness-implementation hybrid design type 3 will be undertaken using the Framework for the Implementation of Services in Pharmacy (FISpH). The study will be carried between October 2020 and December 2022. Two type of practice change facilitators FaFa and SEFaFa. Their main function, using the Observe-Plan-Do-Study-Act process, will be to facilitate the implementation through individualised continuous support to providers of the MAS. The depth and breadth of support to pharmacist providers by each type of change agents will vary. Pharmaceutical Associations (PA) and/or Spanish Society of Community Pharmacy (SEFAC) will invite community pharmacies/pharmacists. Participating pharmacists will need to sign a commitment form. The second study population will consist of patients presenting with minor ailments or requesting a non-prescription medication. Recruitment of patients will be carried out by the pharmacist providers. The inclusion criteria will be: patients or caregivers (aged ≥18 years, or younger if they are accompanied by an adult) presenting with 31 minor ailments, grouped into five categories (respiratory, moderate pain, digestive, dermatological and other) with pre-agreed referral protocols. Other symptoms may be included at the discretion of the pharmacists. The exclusion criteria will be patients who do not provide informed consent. The patient/pharmacist intervention will consist of a MAS protocol adapted for each symptom. The consultation will be record in an electronic data capture system (SEFAC eXPERT®-) that provides a step-by-step approach with protocols and clinical information embedded. The FISpH model will be used to guide the implementation of MAS. Two types of change agents, FaFas and SeFaFas, previously trained for 18 hours, will be used to facilitate the implementation. During each of the stages (exploration, preparation, testing and operation, and initial sustainability), strategies will be used by FaFas and SeFaFas to moderate implementation factors. The impact of strategies will be evaluated. Data on pharmacy/pharmacist's provider performance and patient outcomes will be provided to pharmacist, change agents and PA and SEFAC. FaFas and SeFaFas will have a classification system for barriers and facilitators derived from the constructs in the Consolidated Framework for Implementation Research (CFIR). The classification system for implementation strategies consists of an adaptation of the facilitation activities listed by Dogherty et al. These will be documented in an electronic data capture system. FaFas will train their pharmacists (max. of 25 pharmacies) for 6 hours and subsequently provide at least monthly follow-up. The research team will provide ongoing feedback and support to the FaFas and SeFaFas through periodically, hold group meetings by video conference between the research group and all the FaFas and SeFaFas. The research group will provide formal reports on the implementation process and patient outcomes. Other forms of communication such as emails, telephone calls or WhatsApp messaging will also be available. Implementation and patient consultation process and outcome variables will be measured such as reach, fidelity and integration. Outcome service indicators will be clinical, economic and humanistic. A patient follow up will occur at a maximum of 10 days. Continuous variables will be reported using mean and standard deviation, or median and percentiles. Categorical variables will be reported using percentages. T Student's test or the ANOVA test or Kruskal-Wallis. χ2 test, Fisher's exact test or Yate's chi-squared will also be used. To determine the relationship between the dependent and the independent variables, logistic regression models will be performed including the variables with statistical significance in the bivariate model. The level of significance will be set at p <0.05. Machine learning and big data techniques are being considered for predictive modelling. The research team will only have access to de-identified data of pharmacists and patients. This study protocol has been approved by the Granada Research Ethics Committee on the 5th February 2020.