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NCT ID: NCT04131751 Completed - Ascites Infection Clinical Trials

Application of Clinical Metagenomics in the Diagnosis of Ascites

Start date: October 1, 2019
Phase:
Study type: Observational

Infection of the ascitic fluid is a serious complication associated with high morbidity and mortality. This fluid is often colonized with bacteria that can cause infection of the peritoneum and possibly sepsis. Many bacteria of the human intestinal microbiome can't be cultured by standard methods; therefore it seems likely that many of the relevant bacteria are not discovered in routine diagnostics, but may be relevant to pathogenesis. Culture-independent approaches such as NGS (Next generation Sequencing) have in principle made it possible to study or prove complex microbial colonization. Because NGS is a relatively new technology, microbiological diagnostic protocols need to be further customized and refined to integrate with the standard diagnostic workflow, if necessary. For microbiological diagnostics, material is collected from the appropriate ascites patients and sent for microbiological diagnostics. Afterwards the cultural diagnostics are carried out as part of the patient care at the university hospital. In this study the investigators plan to use these samples to analyze and compare the presence of bacteria by NGS in parallel to the culture diagnostics, and then compare it to the patients' gut microbiome, to understand the possible effect of the microbiome on ascites pathogenesis and outcome.

NCT ID: NCT04130165 Recruiting - Preterm Birth Clinical Trials

Matching Donor Human Milk On Maternal Secretor Status (MMOMSS) Study

MMOMSS
Start date: May 29, 2023
Phase: N/A
Study type: Interventional

This study will evaluate the impact of matching donor human milk to the maternal secretor status of very preterm infants (<34 weeks gestation) on the gut microbiome. Half of enrolled infants will receive donor human milk which is matched their mother's secretor status and half will receive standard (unmatched) donor human milk, which is standard care in the neonatal intensive care unit.

NCT ID: NCT04129398 Completed - Clinical trials for Cytomegalovirus Infection

MK-8228 (Letermovir) in the Prevention of Human Cytomegalovirus (CMV) Infection and Disease in Adult Japanese Kidney Transplant Recipients (MK-8228-042)

Start date: December 27, 2019
Phase: Phase 3
Study type: Interventional

This study aims to evaluate the safety, efficacy and pharmacokinetics (PK) of Letermovir (LET) administered as prevention of cytomegalovirus (CMV) infection and disease in adult Japanese kidney transplant recipients.

NCT ID: NCT04129177 Completed - Clinical trials for Colorectal Neoplasms

Reduction of Surgical Site Infections in Elective Colorectal Surgery After the Implementation of a Bundle of Care.

Start date: October 1, 2018
Phase:
Study type: Observational [Patient Registry]

Background. The Nosocomial Infection Surveillance Program in Catalonia (VINCat) monitors SSI in elective colorectal surgery since 2007 in 56 hospitals (7.5 million population). These hospitals perform active and prospective standardized surveillance of elective colorectal resections. Post-discharge surveillance is mandatory up to 30 days after surgery. Between 2007 and 2015, the SSI rate did not change significantly, with a cumulated incidence of 5,491 SSI in a total of 29,006 interventions (19%). In 2015, a working group of VINCat specialists and surgeons from the Catalan Society of Surgery was set up to formulate a specific bundle of SSI preventative measures for colorectal surgery. Aim. To analyse the effect of a specific bundle for SSI prevention in elective colorectal surgery. Methods. In 2016, a bundle of six preventative measures was recommended to the VINCat hospitals. Bundle measures were: systemic and oral antibiotic prophylaxis, mechanical bowel preparation (MBP), laparoscopic surgery, maintenance of normothermia, and the use of a double-ring wound retractor. The results of SSI before and after the implementation of the bundle are compared. The results are analysed using the chi-square test (statistical significance p <0.05).

NCT ID: NCT04126031 Terminated - Clinical trials for Gram-negative Bacterial Infection

Evaluation of Pharmacokinetics, Safety, and Tolerability of Ceftazidime-avibactam in Neonates and Infants.

NOOR
Start date: January 14, 2020
Phase: Phase 2
Study type: Interventional

This study will assess the pharmacokinetics, safety, and tolerability of single and multiple doses of intravenous ceftazidime-avibactam in hospitalized infants and neonates from 26 weeks gestation to 3 months of age. In Part A of the study all patients will receive a single dose of ceftazidime-avibactam. In Part B all patients will received multiple doses of ceftazidime-avibactam. Efficacy will be assessed in the infants and neonates receiving multiple doses of ceftazidime-avibactam.

NCT ID: NCT04124198 Recruiting - Quality of Life Clinical Trials

Quality of Life After Primary TORS vs IMRT for Patients With Early-stage Oropharyngeal Squamous Cell Carcinoma

QoLATI
Start date: March 1, 2019
Phase: N/A
Study type: Interventional

Oropharyngeal squamous cell carcinoma (OPSCC) is now the most frequently diagnosed head and neck cancer in Denmark which is mainly due to the increase of Human Papillomavirus (HPV). Patients with HPV-positive OPSCC have a significantly higher survival rate compared to HPV-negative OPSCC. The traditional primary treatment modality in Denmark is Intensity Modulated Radiation Therapy (IMRT), and in advanced stages in combination with chemotherapy. Since 2009, Transoral Robotic Surgery (TORS) has enabled surgeons to perform minimally invasive surgery as an alternative to standard radiotherapy treatment which is considered the primary treatment for OPSCC in many countries. There is a lack of randomised trials comparing long-term functional outcomes after TORS or IMRT. Current data are mostly derived from retrospective studies with selection bias. However, several small retrospective studies have shown promising results when comparing the two treatment modalities in favour of TORS with regards to treatment related swallowing function and quality of life (QoL) without compromising survival outcomes. This study aims to evaluate the early and long-term functional outcomes following two treatment arms 1) TORS combined with neck dissection and 2) IMRT±concurrent chemotherapy with a special focus on swallowing-related QoL.

NCT ID: NCT04121169 Recruiting - Clinical trials for Clostridium Difficile Infection (CDI)

Treatment of Mild-moderate Clostridium Difficile Infection (CDI)

IM-01
Start date: October 4, 2019
Phase: Phase 2
Study type: Interventional

Patients diagnosed to have mild-moderate CDI will be randomized to receive IM-01 egg-derived anti-C. difficile polyclonal antibodies in increasing dosages, twice daily, for a total of 10 - 14 days. Resolution of diarrhea and other symptoms and fecal test parameters will be used to assess clinical effectiveness of Immunotherapy with IM-01 antibodies. Patients will be followed for recurrence of CDI. Subjects who are assessed as non-respondents to IM-01 will be reassessed and treated with standard of care CDI antibiotics for 10 -14 days.

NCT ID: NCT04120415 Completed - HIV-1-infection Clinical Trials

A HIV Vaccine Trial in Individuals Who Started Antiretrovirals During Primary or Chronic Infection (EHVA T02)

Start date: June 21, 2022
Phase: Phase 2
Study type: Interventional

EHVA T02 is an international, phase II, double-blind study to evaluate two experimental arms each compared to placebo control in HIV-1 positive participants to see if either has a clinically relevant impact on viral replication.

NCT ID: NCT04119804 Recruiting - Clinical trials for Hip Prosthesis Infection

Early Discrimination of Periprosthetic Hip Infections Using Neural Networks (SEPTIC-ANNR)

SEPTIC-ANNR
Start date: October 3, 2019
Phase:
Study type: Observational

The study is about the role of cellular neural networks-genetic algorithm in the diagnosis of periprosthetic hip infections. A retrospective case series of septic and aseptic loosening of primary hip arthroplasties is selected. The diagnosis of septic loosening is made according to well-established criteria (CDC 2014 and culture samples). The serial radiographs of the selected patients are processed using cellular neural networks-genetic algorithm. The purpose of this study is to evaluate whether neural networks (cellular neural networks-genetic algorithm), applied to conventional radiographies, are accurate, sensitive and specific for the early-discrimination of a periprosthetic hip infection, already diagnosed with well-recognized methods (CDC 2014).

NCT ID: NCT04112303 Completed - Clinical trials for Hepatitis C Virus Infection

Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination for 12 Weeks in Adults With Chronic HCV Infection and Compensated Cirrhosis

Start date: October 16, 2019
Phase: Phase 3
Study type: Interventional

The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of therapy with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) in adults with chronic hepatitis C virus (HCV) infection and compensated cirrhosis.