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Communicable Diseases clinical trials

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NCT ID: NCT05210920 Completed - Clinical trials for Surgical Site Infection

RBG: Regular, Bare, Gel: Does Type of Nail Polish Affect Bacterial Counts After Surgical Scrubbing?

RBG
Start date: May 28, 2021
Phase: N/A
Study type: Interventional

Purpose: The purpose of this study is to evaluate if type of nail polish (gel polish or regular polish) has an effect on the number of bacterial colonies on finger nails after surgical scrubbing. Participants: The potential participants are healthcare providers with patient interaction. Exclusion criteria include evidence of active dermatitis or other skin abnormalities, or allergy to chlorhexidine. Intervention: Participants will have gel nail polish applied to one finger of their dominant hand, and regular polish applied to another finger of their dominant hand. Bacterial swabs will be collected from these two fingers, as well as the from the adjacent finger with no nail polish. Specimen collection will occur both before and after scrubbing with surgical soap. Bacterial counts will be compared between the three groups to determine the association between the presence of nail polish and nail polish type on bacterial counts after surgical scrubbing. Specimen collection will not take place during scrubbing for actual patient care.

NCT ID: NCT05201079 Completed - Clinical trials for Recurrent Clostridium Difficile Infection

Primary or Recurrent Clostridioides Difficile Infection Treatment With Capsules of Lyophilised Faecal Microbiota vs Fidaxomicin

Start date: October 29, 2021
Phase: Phase 3
Study type: Interventional

Patients with microbiota alterations developed after being exposed to antibiotics are especially susceptible to Clostridioides difficile infections (CDI). The incidence and severity of CDI has increased in recent years and CDI recurrences (r-CDI) due to the appearance of new episodes in patients with a previous cured CDI, represent a serious and complex clinical issue. Although antibiotics are the recommended therapy for the first episode of CDI, treatment with oral vancomycin and/or metronidazole often results in significant treatment failure. In addition, the treatment of r-CDI is not adequately standardized, and although the most widely used treatment is the administration of fidaxomicin and bezlotoxumab, its efficacy in patients who already have r-CDI is not proven. In the late years, Fecal Microbiota Transfer (FMT) has emerged as the preferred non-pharmacological treatment to manage CDI with multiple recurrences and recent clinical trials have evaluated its potential efficacy and safety in the treatment of patients with primary CD infection. The objective of this study is to assess the efficacy and safety of the MBK-01 medication, consisting of heterologous lyophilized fecal microbiota capsules coming from healthy donors in comparison to the treatment with Fidaxomicin, in 66 patients with primary or r-CDI.

NCT ID: NCT05195866 Completed - Clinical trials for Respiratory Tract Infections

CRP for Respiratory Diagnosis in Kyrgyz Pediatric Practice

COORDINATE
Start date: November 1, 2022
Phase: N/A
Study type: Interventional

Rationale: Overuse of antibiotics globally is leading to increasing rates of antibiotic resistance and may lead to a 'post-antibiotic' era. Case fatality rates for pneumonia in children remain high in Central Asia and there is a lack of knowledge of which viruses and bacteria cause the disease. Antibiotic resistance patterns of common bacteria remain largely unknown in Central Asia which makes it challenging for clinicians to choose the right antibiotic to treat children with suspected bacterial pneumonia and sometimes healthcare workers overuse an antibacterial therapy even when the child does not need it. Randomised trials of using CRP point of care test (POCT) to guide antibiotic prescription for respiratory tract infections has been successful in lowering unnecessary antibiotic prescriptions in adults in high income countries but left a small concern for safety in the form of possibly slightly increased risk of hospitalisation in the CRP group. Objective: This study seeks to gain evidence on whether use of C-reactive protein point-of-care test can safely decrease prescription of antibiotics for children under 12 with acute respiratory symptoms in primary level healthcare centres in Kyrgyzstan. Study design: Multicentre, open-label, individual randomised controlled clinical trial with 14 days blinded follow-up in rural Chui and Naryn regions of Kyrgyz Republic. Healthcare workers from ten selected healthcare centres will be trained in the CRP POCT and in interpreting the results in the field. Study population: Children aged from 6 month to 12 years attending the primary level healthcare centres during normal business hours with acute respiratory symptoms. Main study parameters: The proportion of patients in the two groups prescribed an antibiotic within 14 days of index consultation; length of disease, antibiotics given at index consultation, admissions and vital status. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Risks, inconvenience and burden associated with participating in this observational study are low. As part of the inclusion children in the CRP cluster group will have a finger-prick test performed. This may be unpleasant and course transient discomfort but poses no risks to the child. Follow-up will be three short phone calls day 3, 7 and 14 after inclusion. Risks includes possible undertreatment of serious disease, however previous studies have not found safety issues with CRP testing in children. There is no direct benefit to participants, but side effects and non-necessary medications are likely minimised.

NCT ID: NCT05188482 Completed - Clinical trials for SARS CoV 2 Infection

Using Vibroacoustic Therapy in a Patient With Co-infection and COVID-19

Start date: September 29, 2020
Phase:
Study type: Observational [Patient Registry]

This article describes a case of successful treatment of a 59-year-old man with sepsis as a result of periprosthetic infection against the background of severe SARS-CoV-2-19, who was hospitalized for 59 days, 57 of which were in the intensive care unit. Vibroacoustic pulmonary therapy, the concept of noninvasive ventilation, syndrome therapy, combination antibiotic therapy taking into account the pathogen and antibiotic sensitivity were used in the treatment.

NCT ID: NCT05180201 Completed - Safety Issues Clinical Trials

SEPSIS: L. Plantarum Trial

Start date: January 7, 2022
Phase: Phase 2
Study type: Interventional

Sepsis is a life-threatening clinical syndrome and a leading cause of neonatal deaths worldwide. The burden of neonatal sepsis and severe infection (SI) is particularly high in areas of South Asia and other resource-limited settings. The goal of the Synbiotics for the Early Prevention of Severe Infections in Infants (SEPSIS) phase II L. plantarum trial is to generate knowledge on the safety, tolerability and effects on the microbiome of Lactiplantibacillus plantarum, with or without fructooligosaccharide, in infants (birth to 60 days of age) in Dhaka, Bangladesh. All data generated will support the design and implementation of a phase III trial to test the efficacy of the probiotic/synbiotic or other interventions for the prevention of SI, promotion of optimal growth and development, and effects on other health outcomes in early infancy.

NCT ID: NCT05175963 Completed - COVID-19 Clinical Trials

Surveillance Among Healthcare Workers for SARS-Coronavirus-2 Infection

Start date: April 22, 2020
Phase:
Study type: Observational

This study aims to investigate the epidemiology of SARS-CoV-2 infection among: i) HCW who triage patients with suspected SARS-CoV-2 infection and provide care to COVID-19 patients; and ii) laboratory personnel who test clinical samples for SARS-CoV-2 infection. After the second wave of the pandemic enrolment will be widen to any person working at the study hospitals.

NCT ID: NCT05175833 Completed - Clinical trials for Microbial Colonization

Oral Probiotics and Secondary Bacterial Pneumonia in Severe COVID-19

Start date: September 11, 2020
Phase: Phase 2
Study type: Interventional

Background and aims: Patients with severe Coronavirus Disease 2019 (COVID-19) are prone to secondary bacterial pneumonia. The use of probiotics against oral pathogens might prevent lung colonization and progression to bacterial pneumonia. This study aimed to assess the effect of Streptococcus salivarius K12 combined with Lactobacillus brevis CD2 in preventing secondary bacterial pneumonia in patients with severe COVID-19. Methods: This randomized placebo-controlled phase 2 trial involved 70 patients with severe COVID-19 admitted to the intensive care unit (ICU). Patients were randomly assigned to a 7-day course of oral gel containing Streptococcus salivarius K12 2 billion colony-forming units (CFU) and Lactobacillus brevis CD2 4 billion CFU every 8 hours or placebo, starting in the first ICU day. The primary outcome was bacterial pneumonia, established according to clinical, laboratory, radiological, and microbiological findings, whereas secondary outcomes were ICU stay in days and hospital mortality.

NCT ID: NCT05171998 Completed - Clinical trials for Diabetes Mellitus, Type 1

Characterisation of the Immune Response to SARS-CoV-2 Infection / COVID-19 in Type 1 Diabetes

Start date: January 1, 2021
Phase:
Study type: Observational

Emerging clinical details of the current SARS-CoV-2 pandemic have illustrated that there are multiple clinical presentations and outcomes of this viral infection. People with an infection have been reported to have a spectrum of disease from severe acute respiratory distress requiring ventilation, to mild respiratory or gastrointestinal symptoms and asymptomatic presentations. The SARS-CoV-2 pandemic has been accompanied with a substantial increase in the number of individuals presenting with new onset type 1 diabetes [1]. Most individuals presenting with type 1 diabetes since the start of the COVID-19 pandemic are SARS-CoV-2 antibody positive. These findings suggest that SARS-CoV-2 infection can cause type 1 diabetes. Investigators have identified that many individuals presenting with type 1 diabetes since the start of the COVID-19 pandemic are SARS-CoV-2 positive by swab or blood test. Researchers have also observed that T cells in patients who have had COVID recognise some of the peptides in the pancreatic islet cells, which are responsible for production of insulin. These findings suggest that SARS-CoV-2 infection may be associated with new onset of type 1 diabetes. The aim of this project is to understand the host immune response to infection with SARS-CoV-2 over time in convalescent newly diagnosed patients with type 1 diabetes, including acquired immune responses, gene expression profiling in peripheral blood and to identify host genetic variants associated with disease progressions or severity. Participants will have Type 1 diabetes and will have had a diagnosis of COVID-19 (confirmed by a positive nasopharyngeal swab PCR test and/or SARS-CoV-2 antibody test) and have recovered from COVID-19. Samples will be processed and analysed to explore the molecular mechanisms by which SARS-CoV-2 infection might precipitate immune attack on insulin-producing cells resulting in autoimmune diabetes.

NCT ID: NCT05169255 Completed - Clinical trials for Microbial Colonization

Impact of Prolonged Antibiotic Therapy on Commensal Microbial Community Gene Expression.

Start date: December 7, 2012
Phase: Phase 3
Study type: Interventional

Antibiotics are a mainstay of life-saving interventions used frequently in medical practice to combat infections. These medications not only target the pathogenic bacteria for which they are prescribed but also function against commensal bacterial communities that inhabit the gut, skin, and oropharynx. The role that these native bacterial communities play in normal host function, such as in nutrition and host immunity, is only beginning to be explored, as are the changes in the communities and their function as a result of various alterations of antibiotic use. Short courses of antibiotics have been shown to affect the diversity of native bacterial communities, and to affect the abundance of antibiotic resistance genes present. For example, use of clindamycin in human subjects for 7 days has been demonstrated to result in persistent clindamycin resistance for months or years. The impact of prolonged antibiotic therapy on the host microbiome including both those organisms present and the diversity of antibiotic genes has not been studied, and we have very little understanding of the longitudinal effects of antimicrobial therapy on the genetic repertoire present in human microbial communities. In this study, we will examine changes in the microbiota as well as frequency of antibacterial resistance genes harbored in skin, saliva, and colonic microbiomes longitudinally in subjects on prolonged antimicrobial therapy, as well as household members of the person on antibiotic therapy. Previously well patients with minimal prior antibiotic exposure will be enrolled upon diagnosis of an infection requiring long-term antibiotic therapy, such as osteomyelitis or prosthetic joint infection, prior to starting antibiotic therapy. We will examine the microbiota of the skin, saliva, and gut prior to antibiotics as well as the frequency of antibiotic resistance genes harbored within these microbial communities. We will compare microbial communities and antibiotic resistance gene frequencies before, during and after prolonged course of antibiotics in patients on antibiotics. We will also look for alterations that occur among microbiomes or antibiotic resistance genes among household members of people on antibiotics.

NCT ID: NCT05168813 Completed - HIV Infections Clinical Trials

Efficacy Study of COVID-19 mRNA Vaccine in Regions With SARS-CoV-2 Variants of Concern

CoVPN3008
Start date: December 1, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

The study will evaluate the clinical efficacy of different dosing regimens of the Moderna COVID-19 mRNA vaccine (100 mcg) in preventing COVID-19 disease in people who are living with HIV or have comorbidities associated with elevated risk of severe COVID-19, with the different vaccine regimens assessed determined by whether the participant had evidence of prior SARS-CoV-2 infection at enrollment.