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Communicable Diseases clinical trials

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NCT ID: NCT02831673 Completed - HIV Infections Clinical Trials

An Efficacy, Safety, and Tolerability Study Comparing Dolutegravir Plus Lamivudine With Dolutegravir Plus Tenofovir/Emtricitabine in Treatment naïve HIV Infected Subjects (Gemini 1)

Start date: July 21, 2016
Phase: Phase 3
Study type: Interventional

This study will compare safety, efficacy, and tolerability of a two drug regimen of dolutegravir (DTG) plus (+) lamivudine (3TC) administered once daily with DTG plus two nucleoside reverse transcriptase inhibitors (Tenofovir [TDF]/Emtricitabine [FTC] fixed dose combination [FDC]) administered once daily in human immunodeficiency virus (HIV) 1 infected adult participants that have not previously received antiretroviral therapy. The study is designed to demonstrate the non-inferior antiviral activity of DTG plus 3TC regimen to that of DTG plus TDF/FTC FDC and will characterise the long term antiviral activity, tolerability and safety of DTG plus 3TC through Week 148. Approximately, 700 participants will be randomised 1:1 to receive DTG + 3TC or DTG + TDF/FTC FDC. Participants will be stratified by screening HIV 1 ribonucleotide nucleic acid (RNA) levels and by screening CD4+ (cluster of differentiation 4) cell count.

NCT ID: NCT02830542 Completed - Clinical trials for Clostridium Difficile Infection

SER-262 Versus Placebo in Adults With Primary Clostridium Difficile Infection to Prevent Recurrence

Start date: August 2016
Phase: Phase 1
Study type: Interventional

The study will involve administering a single dose of investigational drug or placebo in ascending dose cohorts. This study is designed to evaluate the safety and tolerability of investigational drug as well as the efficacy of investigational drug versus placebo in adults with primary (first episode) Clostridium difficile infection (CDI).

NCT ID: NCT02823132 Completed - Acute Leukemia Clinical Trials

Study of the Level of a Protein Which Could Predict the Development of a Fungal Infection in Patients With Acute Leukemia

MBL INFFONG
Start date: n/a
Phase: N/A
Study type: Observational

The aim of this study is to investigate levels of a protein, mannose binding lectin, in patients with acute leukemia who develop or not an invasive fungal infection.

NCT ID: NCT02822794 Completed - Clinical trials for Hepatitis C Virus Infection

Sofosbuvir/Velpatasvir Fixed-Dose Combination and Ribavirin for 12 or 24 Weeks in Participants With Chronic Genotype 1 or 2 Hepatitis C Virus Infection Who Have Previously Failed a Direct-Acting Antiviral-Containing Regimen

Start date: July 25, 2016
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the antiviral efficacy, safety, and tolerability of therapy with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) and ribavirin (RBV) in participants with chronic genotype 1 or 2 hepatitis C virus (HCV) infection who have previously failed a direct-acting antiviral (DAA)-containing regimen.

NCT ID: NCT02819232 Completed - Clinical trials for Infectious Keratitis

Microbiological Diagnosis of Infectious Keratitis to Pathogenic Fastidious Germs

Keratite
Start date: August 12, 2013
Phase: N/A
Study type: Interventional

Infectious keratitis are favored by the circumstances causing the small trauma of the corneal epithelium, corneal surgery, corneal dryness under health system such as Sjögren's syndrome rheumatoid arthritis, or much more frequently wearing contact lenses. If the majority of infectious keratitis are favourable, some lead to serious injury of the cornea, or even corneal perforation which result an endophthalmitis. This unfavourable evolution may lead to blindness due to corneal damage, the endo-ocular lesions or enucleation of the eyeball. This negative evolution is encountered while the infectious keratitis due to tedious germs of difficult diagnosis such as nontuberculous Mycobacterial, fungal infections, fungal keratitis, amoebic keratitis, and certain viral keratitis. The microbiological diagnosis of routine is based on the systematic search for pathogens tedious from invasive sampling of cornea by vaccinostyle. We set up a new non-invasive corneal swab diagnostic method.

NCT ID: NCT02817282 Completed - Clinical trials for Infectious and Communicable Diseases

Compliance With Hand Hygiene in Nursing Homes: Go for a Sustainable Effect (CHANGE)

CHANGE
Start date: November 2015
Phase: N/A
Study type: Interventional

Hand hygiene (HH) appears to be a simple, non-complex procedure to prevent healthcare-associated infections (HAIs), implementation in daily routine is difficult. The residential setting and specific population pose challenges to optimal HH compliance. This study aims to develop and to evaluate an evidence based multi-component implementation strategy aimed at the promotion of HH in Dutch nursing homes(NHs). A strategy to improve HH compliance in Dutch NHs will be developed. This strategy addresses the specific barriers and facilitators of NHs' infrastructure, healthcare workers (HCWs) and socio-cultural setting. The strategy will be tested in a stepped wedge cluster randomized design which is based on a random sequential roll-out of the implementation strategy to all participating NHs (n=20) for comparison. Data are collected during six consecutive four month periods with an initial baseline period for all NHs. During each period 1200 opportunities for HH are observed, using the gold standard of direct and unobtrusive observations, according to the Five Moments for HH of the World Health Organization. HAIs incidence densities, collected in the sentinel surveillance network for infectious diseases in nursing homes (SNIV), will be evaluated in parallel. A multi component implementation strategy, combining activities aimed at individual HCWs, teams and the organization will be used. The individual level includes education, skills, action planning, reminders and feedback. The team level includes activities that focus on social influence, strengthening of leadership by gaining active commitment and initiative of ward management. The organizational level addresses the structural context and institutional management support. To assess the cost implications of the CHANGE strategy, an economic evaluation will be conducted from a healthcare perspective. The cost-effectiveness of improved HH, defined here as the costs for the CHANGE strategy minus less costs for treating infections, divided by the difference between HAIs before and after the intervention period, will be calculated. A process evaluation will be performed during and after the intervention to investigate the feasibility of the implementation strategy and to illuminate the mechanisms and processes responsible for the results and their variation within the NHs.

NCT ID: NCT02814916 Completed - Clinical trials for Bacterial Infections

Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections in Children, Known or Suspected to be Caused by Susceptible Gram-positive Organisms, Including MRSA

Start date: March 31, 2017
Phase: Phase 3
Study type: Interventional

To determine the safety and descriptive efficacy of dalbavancin for the treatment of acute bacterial skin and skin structure infections in children, aged birth to 17 years (inclusive), known or suspected to be caused by susceptible Gram-positive organisms, including methicillin-resistant strains of Staphylococcus aureus.

NCT ID: NCT02812446 Completed - Clinical trials for Staphylococcal Infection

Staphylokinase and ABO Group Phenotype: New Players in Staphylococcus Aureus Implant-associated Infections Development

Start date: February 2012
Phase: N/A
Study type: Observational

The purpose of this study is to identify bacterial and/or clinical features involved in the pathogenesis of Staphylococcus aureus implant-associated infections (IAI). Materials & methods: In total, 57 IAI S. aureus and 31 nasal carriage (NC) S. aureus isolates were studied. Staphylococcus aureus genetic background was obtained by microarray analysis. Multilocus sequence typing was performed to determine clonal complexes (CC). Biofilm production was investigated by resazurin and crystal violet methods

NCT ID: NCT02810678 Completed - Clinical trials for Latent Tuberculosis Infection

Enhancing the Public Health Impact of Latent Tuberculosis (TB) Infection Diagnosis and Treatment

ACT4
Start date: July 2016
Phase: N/A
Study type: Interventional

The study is a pragmatic cluster randomized trial that is being conducted in 5 countries, with sites in 4 cities in Canada, Benin, Ghana, Indonesia and Vietnam. The unit of randomization is the health facility (24 health facilities randomized). The trial tests a complex intervention-a two phase programmatic public health package which includes a standardized public health evaluation and analysis, to identify problems and barriers limiting Latent Tuberculosis Infection diagnosis and treatment among close contacts of active Tuberculosis cases. This will be followed by implementation of appropriate solutions and strengthening of the LTBI clinical program. The primary objective will be to estimate the increase the number of household contacts initiating LTBI treatment per newly diagnosed index patient, within 3 months of diagnosis of the index patient. A secondary objective is to evaluate the cost effectiveness of this two phase intervention. If successful, this approach can be expanded throughout these countries. After initial preparations, including administrative and ethical review, all participating sites will be randomized to intervention or control. Immediately after this, Phase 1 will begin in intervention sites with the standardized public health evaluation to identify barriers to LTBI diagnosis and treatment initiation and the selection of solutions to be used in Phase 2. To ensure standardization of data gathering research staff will use (i) current indicators of the Latent Tuberculosis Infection cascade of care in intervention facilities (number of contacts per index case registered, investigated, started on treatment and completing treatment) and (ii) interviewer administered questionnaires for patients with active pulmonary Tuberculosis, adult and child household contacts and clinic staff. These questionnaires will assess latent Tuberculosis-related knowledge, attitudes and beliefs from the perspective of these different participants. Results from intervention sites in Phase 1 will be analyzed, and used by the investigators, together with local public health officials, to decide on appropriate corrective solutions in each sites. Contact Investigation registries will also be developed with research staff from sites. In Phase 2, solutions for problems identified will be selected and implemented at the intervention sites, Contact Investigation registries will be implemented and clinical training will be provided to strengthen LTBI health care worker knowledge and clinical programs. Study outcomes and costs will be measured at all intervention and control sites throughout Phase 1 & 2. The main study will run for 18 months. Upon completion of the main study, a 1 year cross over study will be conducted where control sites will receive a streamlined version of the intervention and original intervention sites will be used to evaluate the sustainability of the intervention. Results will be disseminated within each country through existing links with National Tuberculosis Programs, and through international organizations such as the World Health Organization.

NCT ID: NCT02809352 Completed - HPV Infection Clinical Trials

Epidemiology of High-risk HPV Infection in Women Participating in a Pilot Screening Program for Cervical Cancer

Epi-START
Start date: July 2012
Phase: N/A
Study type: Observational

Cervical cancer is due to a persistent infection with a group of viruses known as high-risk Human Papillomaviruses (hrHPV). Viral DNA can be easily detected in a cervical sample by a procedure called 'HPV testing', which can be used as a relevant screening test. A pilot screening program called START-HPV has been set up in the Ardennes, a French administrative area localized in the North of France, with HPV testing as a primary screening test.This observational study aimed to evaluate hrHPV genotypes repartition in the population who participate in the START-HPV screening program. This study will allow a better knowledge of hrHPV infection epidemiology in a screened population.