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Candidiasis clinical trials

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NCT ID: NCT02220790 Completed - Clinical trials for Invasive Candidiasis

BIOPIC: Fungal Biomarkers for Diagnosis and Response to Therapy for Pediatric Candidemia

BIOPIC
Start date: January 2015
Phase:
Study type: Observational [Patient Registry]

The purpose of the study is to 1) define the operating characteristics of fungal biomarker assays in pediatric patients at high-risk for developing invasive candidiasis, 2) determine the change in fungal biomarker assay results in children who develop invasive candidiasis, and 3) create a biobank of blood samples from pediatric patients at high-risk for invasive candidiasis and those with invasive candidiasis for future testing of fungal biomarker assays and development of new fungal biomarker assays. The study will assemble a prospective cohort of pediatric patients at high-risk for developing invasive candidiasis. Blood samples for biomarker testing will be obtained at the time a patient has a clinical indication for blood culture attainment. Additional blood sampling will be performed on the sub-set of patients that are found to have invasive candidiasis. The sensitivity, specificity, PPV, and NPV of biomarker assays will be determined for each biomarker assay. No PHI will be stored in the database and limits on blood draws (3 ml/kg in an 8 week period) will be adhered to.

NCT ID: NCT02203942 Completed - Bacterial Vaginosis Clinical Trials

Comparing NAAT Testing to Standard Methods for the Diagnosis of Vaginitis

VAST
Start date: July 2014
Phase: N/A
Study type: Observational

Vaginitis is the most common condition encountered in the gynecologist's office and is most commonly caused by bacerial vaginosis (BV), vulvovaginal candidiasis (VVC) and Trichomonas vaginalis (TV). Establishing the correct etiology of symptomatic vaginitis can be challenging, and the evaluation of vaginitis by physicians is often substandard. The investigators will determine whether NAAT testing will improve the diagnosis of vaginal infections including bacterial vaginosis (BV), vulvovaginal candidiasis (VVC) and Trichomonas vaginalis (TV).

NCT ID: NCT02201745 Completed - Dental Plaque Clinical Trials

Palatal Brushing for Denture Stomatitis

Start date: June 2012
Phase: N/A
Study type: Interventional

Several dental professionals recommend that complete denture wearers should brush their palate. Some advantages include better cleansing and blood flow, which may help to prevent or treat oral infections, such as denture-related stomatitis. However, there is no previous clinical trial dealing on that subject. Therefore, our goal is to evaluate whether palatal brushing may change the severity of denture stomatitis or counts of microbes on dentures and mucosa. After an initial exam and data collection, participants will receive instructions for palatal hygiene and will be assessed following 1 and 3 months. Collected data include patient-reported information, intraoral photographs and swabbing (for counting microbes). Tested Hypotheses: - There is no difference in the extent of palatal inflammation in edentulous patients with denture stomatitis before and after 3 months of palatal brushing. - There is no difference in the number of colony forming unit (CFU) of Candida isolated from palate and denture of patients affected by denture stomatitis before and after 3 months of palatal brushing.

NCT ID: NCT02184351 Completed - Candidiasis, Oral Clinical Trials

Clotrimazole vs. Mycelex® in Patients With Human Insufficiency Virus (HIV) Infection for the Treatment of Oropharyngeal Candidiasis

Start date: May 2001
Phase: Phase 3
Study type: Interventional

The objectives of this study are to compare the efficacy and safety of Roxane's clotrimazole troches vs. Mycelex troches in HIV positive patients with oropharyngeal candidiasis, where this condition has been diagnosed by clinical examination and confirmed by fungal culture.

NCT ID: NCT02180828 Completed - Clinical trials for Candidiasis, Vulvovaginal

Clotrimazole Vaginal Tablet vs Fluconazole for Severe Vulvovaginal Candidiasis

Start date: July 2014
Phase: Phase 4
Study type: Interventional

The study is focused to prove that the efficacy and safety of Clotrimazole vaginal tablet vs Fluconazole for the treatment of severe vulvovaginal candidiasis

NCT ID: NCT02180100 Completed - Clinical trials for Vulvovaginal Candidiasis

Terconazole Vaginal Suppository vs Fluconazole for the Treatment of Severe Vulvovaginal Candidiasis

Start date: August 2013
Phase: Phase 4
Study type: Interventional

The objectives of this study were to demonstrate comparable safety and efficacy of Terconazole Vaginal Suppositories, 80 mg and fluconazole in the treatment of subjects with severe vulvovaginal candidiasis.

NCT ID: NCT02164890 Completed - Clinical trials for Invasive Candidiasis

Pharmacokinetics of Micafungin in Patients of Intensive Care Units

MI-K
Start date: June 2014
Phase: Phase 4
Study type: Interventional

Invasive fungal infections (IFIs) are a frequent cause of morbidity and mortality in high-risk patients, such as immunocompromised patients. Candida is currently the predominant fungal pathogen in these patient populations and is associated with significant morbidity and a high mortality. Micafungin (MCF) is a semisynthetic compound belonging to the new class of antifungal agents, the echinocandin lipopeptides, that has potent in vitro and experimental in vivo activity against a variety of pathogenic Candida species and Aspergillus species. Its applied indications are so the treatment and/or the prophylaxis of Candida and Aspergillus infections. MCF is currently licensed for the treatment of candidiasis at doses of either 100 or 150 mg a day. The efficacy of MCF is linked to the area under the concentration-time curve over 24 h in the steady state divided by the MIC (AUC0-24/ MIC ratio). On one hand: - It was demonstrated that 98% of invasive candidiasis patients with a MCF AUC/MIC ratio between 3 and 12 achieve microbiological clearance, as opposed to only 85% of those with an AUC/MIC ratio < 3. In the case of infections by Candida parapsilosis, which exhibits drug MICs that are 50- to100-fold higher, 100% of patients with an AUC/MIC ratio >285 achieve microbiological clearance, as opposed to 82% of those below that exposure level.(1) On the other hand: - It is well known that patients of intensive care units (ICU) are characterized by particular pharmacokinetic parameters with higher apparent volume of distribution (VC/F) and/or higher apparent systemic clearance (CL/F). In a population of healthy volunteers, it was observed that CL/F of MCF presents a high interpatient variability.(2) - Whether most ICUs patients achieve optimal AUC/MIC ratio thresholds at standard doses has not been investigated so far. In particular, lower AUCs might be reached in patients having the highest VC/F values. Such patients would then be at risk of therapy failure and would benefit from individualized-dosing strategies. In this context, the study of the pharmacokinetics of MCF in critically ill patients seems to be necessary.

NCT ID: NCT02150655 Completed - Bacterial Vaginosis Clinical Trials

Study of the Microbiota, Metabolome, and Environmental Toxins in Relation to Reproductive Health in Rwandan Women

RVMM
Start date: September 2012
Phase: Phase 0
Study type: Interventional

The overall objective of this clinical pilot study is to determine at a random sampling time, the vaginal microbiome and metabolome of pregnant women, and to see if infection (bacterial vaginosis, vulvovaginal candidiasis, malaria) and exposure to environmental toxins affects could alter pregnancy and conception outcomes. It is hypothesized that infection and toxins will alter the vaginal microbiome and metabolome, increasing the risk of preterm labour and infertility in Rwandan women. In a sub-group of subjects, a preliminary assessment of the ability of orally administered probiotic lactobacilli to restore the vaginal microbiota to a healthy state and lower environmental toxins will be completed.

NCT ID: NCT01994096 Completed - Critically Ill Clinical Trials

Optimal Dosage of Caspofungin in Critically Ill Patients

Start date: November 2013
Phase: Phase 4
Study type: Interventional

Intensive care unit (ICU) patients are especially at risk for invasive candidiasis due to the presence of risk factors. It is known that in critically ill patients, alterations in function of various organs and body systems can influence the pharmacokinetics and hence the plasma concentration of a drug. A study of caspofungin in ICU patients has found a high inter- and intra-individual variability in caspofungin concentration. Factors that caused subtherapeutic caspofungin plasma concentrations were body weight > 75 kg and hypoalbuminemia. Furthermore, an efficacy study showed a lower response rate for caspofungin among patients with a higher disease severity score. As a result of the altered pharmacokinetics, under- or over-exposure of caspofungin can occur in critically ill patients and an adjusted dosage might be necessary in these patients.

NCT ID: NCT01926028 Completed - Clinical trials for Vulvovaginal Candidiasis

Safety, Tolerability, Immunogenicity and Efficacy of NDV-3A Vaccine in Preventing Recurrent Vulvovaginal Candidiasis

Start date: July 2013
Phase: Phase 1/Phase 2
Study type: Interventional

This is a multi-center, randomized, double-blind, placebo-controlled study intended to assess the safety, tolerability and humoral and cellular immune response over a 12-month period after receiving one dose of either the NDV-3A vaccine, NDV-3 vaccine, or placebo. In addition, the clinical efficacy of NDV-3A vaccine in lowering the recurrence rate of vulvovaginal candidiasis (VVC) in patients with recurrent VVC (RVVC) will be evaluated relative to placebo.