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Communicable Diseases clinical trials

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NCT ID: NCT05804058 Completed - Joint Infection Clinical Trials

Biofilm Composition as a Predictive Biomarker for Prosthetic Joint Infection

Biofilms
Start date: July 1, 2019
Phase:
Study type: Observational

Prosthetic joint infection (PJI) represents one of the most common reasons for failure among hip and knee prostheses, with an incidence of around 1-2%. Infection can occur early (within days of surgery) or late (over a year after surgery), and no specific early markers for infection onset exist. Given the significant costs to the NHS for corrective revision surgery, the added suffering and risk to patients from surgery, and the risk of enhancing antimicrobial resistance through the use of broad-spectrum antibiotics, a more specific predictive test for early onset of infection is required.

NCT ID: NCT05803577 Active, not recruiting - Clinical trials for Microbial Colonization

Microbiome Establishment in Preterm Infants

PIMENTO
Start date: April 7, 2021
Phase:
Study type: Observational

Our bodies are home to millions and millions of microbes (bacteria, fungi and viruses), that live in harmony with us without producing any negative (disease producing) effects. Research is beginning to show that these microbes interact with us to help with our immune system, digestive tract and brain development among many other effects. This community of microbes, known collectively as our microbiome, may commence colonisation while we are developing in the womb and becomes quickly established after we are born. Much remains unknown about how preterm birth affects the development of our microbiome. The goal of this longitudinal observational study is to gather more information of how and from where we get those first few microbes, the pattern in which our microbiome develops, and how intensive care for a preterm baby affects this. The main questions it aims to answer are: - How is the gut microbiome of a very premature infant affected by clinical management practices (e.g. antibiotics, probiotics, feeding) and how does it progress subsequently. - How do probiotics colonise the preterm gut, and how do they persist once supplementation is discontinued. Samples will be collected from mothers and their infants during the NICU admission including: - A rectal swab - Meconium and stool - Urine - Blood - Expressed breastmilk - Maternal stool - Maternal oral swab - Maternal vaginal or skin swab (depending on mode of delivery) Samples will be analysed using next generation sequencing techniques to, for example, evaluate microbial composition of the samples or determine functional microbiome-host interactions.

NCT ID: NCT05797818 Completed - Clinical trials for Surgical Site Infection

Red Light Photobiomodulation and Topical Disinfectants

Start date: January 10, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The goal of this clinical trial is to evaluate the potential effects of photobiomodulation when used with topical disinfectants in the anterior nares of healthy adults. Over a three week period, participants will have their anterior nares swabbed with methylene blue, chlorhexidine gluconate, or a combination of the two followed by 4 minutes of non-thermal red light treatment. The fourth week of consist of only red light treatment. Culture samples of the subjects nasal microbiome will be taken prior to treatment, immediately after treatment, 4-, 8-, 24-, and 48 hours after treatment.

NCT ID: NCT05797246 Recruiting - Neoplasms Clinical Trials

Bevacizumab in Adults With Recurrent Respiratory Papillomatosis (RRP)

Start date: August 2, 2023
Phase: Phase 2
Study type: Interventional

Background: Recurrent respiratory papillomatosis (RRP) is a rare disease that causes wart-like growths in the airways. These growths come back when removed; some people may need 2 or more surgeries per year to keep their airways clear. Better treatments are needed. Objective: To see if a drug called bevacizumab can reduce the number of surgeries needed in people with RRP. Eligibility: People aged 18 and older with recurrent RRP; they must need surgery to remove the growths in their airways. Design: Participants will be screened. Their ability to breathe and speak will be evaluated. They will have an endoscopy: a flexible tube with a light and camera will be inserted into their nose and throat. They will have a test of their heart function and imaging scans of their chest. Participants will have surgery to remove the growths in their airways. Bevacizumab is given through a small tube placed in a vein in the arm. After the surgery, participants will receive 11 doses of this drug: every 3 weeks for 3 doses, and then every 6 weeks for 8 more doses. They will come to the clinic for each dose; each visit will be about 8 hours. Tissue samples of the growths will be collected after the second treatment; this will be done under general anesthesia. Participants may undergo apheresis: Blood will be drawn from a needle in an arm. The blood will pass through a machine that separates out the cells needed for the study. The remaining blood will be returned to the body through a second needle. Follow-up will continue for 1 year after the last treatment.

NCT ID: NCT05796362 Not yet recruiting - Infectious Disease Clinical Trials

A Single-Dose, Three-Way, Three-Sequence, Crossover BA Study of Azithromycin Oleogel

Start date: April 2023
Phase: Phase 1
Study type: Interventional

This is an exploratory study to describe the pharmacokinetics of the azithromycin oral and rectal oleogel in humans compared to the reference oral drug to (Zithromax) assess the impact of the novel formulation on bioavailability. The investigators will perform a randomized, balanced, single dose, three-treatment, three-period, crossover oral bioavailability study under fasted conditions to evaluate the safety and tolerability of azithromycin oleogel and compare the bioavailability of the azithromycin oleogel to the reference drug.

NCT ID: NCT05794412 Active, not recruiting - Clinical trials for SARS-CoV-2 Infection

Mucosal Immunity: Influence on Infectious Viral Load: a Prospective Observational Study

MIViral
Start date: January 10, 2023
Phase:
Study type: Observational

The goal of this observational study is to learn about the influence of pre-existing mucosal immunity, i.e. antibodies and immune cells that are present at the nasal mucosa before infection, on the infectious viral load after infection with SARS-CoV-2, influenza virus and RSV. The investigators will include app. 320 participants which will be followed for up to 17 months. During this time, the investigators will monitor their nasal mucosal antibodies at regular intervals and compare them to their infectious viral load if they are infected with SARS-CoV-2, influenza virus or RSV. Participants are invited to take a test for SARS-CoV-2, influenza virus or RSV in case of respiratory symptoms. If participants are positive the investigators will follow their viral load kinetics by taking nasopharyngeal swabs every 2-3 days. The investigators will also record the duration and strength of the following symptoms: - Cough - Fever - Tired - Sore throat - Difficulty breathing - Respiratory distress - Headache - Loss (or alteration) of smell - Loss (or alteration) of sense of taste - Myalgias - Chills - Subjective fever - Pink sputum (or coughing up blood) - Thoracic pain - Runny nose - Abdominal pain - Nausea - Vomiting - Diarrhea - Constipation - Irritated or watery eyes - Rashes - Other

NCT ID: NCT05792878 Recruiting - Chronic Hepatitis B Clinical Trials

Study of COVID-19 Infection and Its Clinical Prognosis in Chronic Hepatitis B Patients With Antiviral Therapy

Start date: September 1, 2022
Phase:
Study type: Observational

This is a two-way (retrospective and prospective) study of COVID-19 infection in an observational cohort of patients with chronic hepatitis B treated with antiviral therapy. Patients with chronic hepatitis B who received anti-HBV treatment in the Second Department of Hepatology, Beijing Ditan Hospital Affiliated to Capital Medical University from February 2022 to December 2023 were enrolled. After enrollment, demographic data of patients, information on antiviral treatment of chronic hepatitis B, COVID-19 vaccination, COVID-19 infection and COVID-19 incidence and treatment from January 2022 to pre enrollment, and data on HBV virus and serology, clinical biochemistry, liver and lung imaging, COVID-19 nucleic acid and COVID-19 antibody examination of patients were collected. After enrollment, prospective anti-HBV treatment, HBV virology, clinical biochemistry, liver imaging and COVID-19 infection and morbidity were observed. The patients with COVID-19 infection during the prospective observation period were observed for COVID-19 infection, onset and treatment, including body temperature, clinical symptoms, signs, cardiac examination, pulmonary imaging, COVID-19, clinical biochemistry, disease severity, time of virus negative conversion, hospital stay and outcome. The influence of COVID-19 infection on liver disease and the influence of interferon anti-HBV treatment on COVID-19 infection, its pathogenesis and prognosis were studied.

NCT ID: NCT05789615 Recruiting - Clinical trials for Hematopoietic Stem Cell Transplantation

Letermovir Prophylaxis for CMV Infection in Haplo-HSCT Recipients: Single-center Data in China

Start date: April 15, 2023
Phase:
Study type: Observational

In the 30 years fighting against CMV infection, the mortality rate of HSCT patients was significantly reduced. Now we should turn to how to better improve the prognosis of HSCT patients and prevent CMV infection. The emergence of letermovir gave this vision a shot in the arm11-13. Letermovir is the only drug with an indication approved for the prevention of CMV infection in HSCT patients, with a novel mechanism of action characterized by inhibition of the CMV DNA terminase complex. The efficacy and safety of letermovir were well demonstrated in key phase III studies, where letermovir prophylaxis significantly reduced CMV infection and all-cause mortality after HSCT without increased myelosuppression and increased nephrotoxicity (vs. placebo)13. A real-world study of letermovir prophylaxis showed a significant reduction in CMV infection rates (47.0% vs 10.7%), and a significant reduction in antiviral use after 180 days. After more than100 days of continuous use, in addition to a significant reduction in clinically significant CMV infections and patients' overall survival increased, significant efficacy was consistently maintained in patients with grade 2 or greater GVHD14-17. A systematic review and meta-analysis of real-world studies on primary prevention in letermovir was showed in EBMT 2022. A total of 48 real-world observational studies were included, and the results showed that the use of CMV primary prevention was effective in reducing the overall risk of CMV performance (including CMV reactivation, cs-CMV infection and CMV disease), all-cause mortality and non-relapse mortality at day 200 in adult HSCT recipients. At 100 days follow-up, CMV reactivation decreased by 87%, meanwhile clinically significant CMV infection by 91%, CMV disease decreased by 69%, CMV-related hospitalization decreased by 94%, and GVHD decreased by 48%18. Letermovir has achieved excellent therapeutic benefits globally but is still in its infancy in China. Letermovir obtained an implied license for a clinical trial in June 2020, and in November 2020, Letermovir submitted and accepted four new drug marketing applications in China, including injection and tablet formulations. On December 31, 2021, the China National Medical Products Administration (NMPA) approved letermovir for cytomegalovirus (CMV) seropositive adult recipients undergoing allogeneic hematopoietic stem cell transplantation (HSCT) [R+] prevention of cytomegalovirus infection and cytomegalovirus disease. The commercial launch of letermovir is estimated to be in August 2022. Since the seropositive rate of CMV in the Chinese population is over 90%, it is not enough to judge whether CMV prevention is necessary depending on serology. In the past few years, with the increased number of only children in China, haploidentical stem cell transplantation (haplo-SCT) has been showing a steady expanding trend in China. Most hospitals' pretreatment methods use the Beijing protocol (including ATG) rather than post-transplant cyclophosphamide method to prevent GVHD, which also greatly increases the risk of CMV. To our knowledge, there is little published data focused on the efficacy of CMV prophylaxis for patients undergoing the haplo-SCT in China. A "real-life" evaluation of the new drug in terms of efficacy, emergence of resistance, tolerance related to CMV infection, is useful to propose recommendations on management strategies. Therefore, we would like to conduct a prospective observation study of CMV surveillance in haplo-SCT patients receiving letermovir prophylaxis in China, to evaluate the potential real-life effect of letermovir on efficacy, drug resistance emergence, tolerability, and CMV infection-related morbidity and mortality. This work contributes to recommendations regarding CMV management strategies, especially for patients at highest risk, i.e., CMV R+ haploidentical transplant recipients.

NCT ID: NCT05789550 Not yet recruiting - H Pylori Infection Clinical Trials

HELICOBACTER PYLORI INFECTION IN TYPE 2 DIABETES MELLITUS IN ASSIUT UNIVERSITY HOSPITAL

Start date: April 1, 2023
Phase:
Study type: Observational

The aim is to study the association of H. pylori infection with T2DM and its relation with glycated hemoglobin (HbA1c) levels

NCT ID: NCT05789199 Completed - Clinical trials for Gram-Negative Infection

Use of Cefiderocol in the Management of Gram-Negative Infections

PERSEUS
Start date: July 31, 2022
Phase:
Study type: Observational

The aim of this study is to describe the use of cefiderocol in the management of Gram-negative infections (GNIs) in participants treated through the Early Access Program (EAP) in Spain.