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Fournier Gangrene clinical trials

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NCT ID: NCT05529628 Completed - Perianal Abscess Clinical Trials

The Immunological Differences Between Fournier Gangrene and Perianal Abscess

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

Although it is rarely observed, necrotizing fasciitis progresses with high mortality and serious complications. Fournier's gangrene is a specific form of necrotizing fasciitis. In laboratory tests, leukocytosis or leukopenia, anemia, lymphopenia can be observed. Perianal abscess is a surgical emergency that is observed much more frequently than necrotizing fasciitis. Although Fournier's gangrene has many different etiologies, it rarely occurs due to the progression of perianal abscess, and although it is difficult to distinguish between these two diseases at diagnosis, the two diseases manifest themselves as different entities. In this study, blood cytokine levels will be evaluated in patients with Fournier's gangrene and perianal abscess, and the role of blood cytokine levels in the differential diagnosis of these two diseases will be investigated.

NCT ID: NCT04983056 Completed - Fournier Gangrene Clinical Trials

Management of Fournier Gangrene at Ibn Rochd University Hospital Center

Start date: January 1, 2010
Phase:
Study type: Observational

Case series with retrospective data collection of patients treated for Fournier's gangrene between January 2010 and March 2017. The main etiologies, risk factors, postoperative complications outcomes and long term follow up results were analyzed.

NCT ID: NCT04694053 Completed - Fournier Gangrene Clinical Trials

Fournier's Gangrene in Patient With Uncontrolled Type 2 Diabetes

Start date: November 4, 2020
Phase:
Study type: Observational

A 66-year-old man, with a history of uncontrolled type 2 diabetes, obesity with BMI 38, chronic kidney failure and chronic heart failure, was admitted to the Emergency Department with a large area of necrosis involving the perineal and perianal regions.

NCT ID: NCT03443544 Completed - Fournier Gangrene Clinical Trials

Fournier's Gangrene and the Origin of the Infection as a Prognostic of Morbidity and Mortality, an Analysis of 121 Patients

Start date: November 1, 2017
Phase: N/A
Study type: Observational

Background: Fournier's gangrene it's a necrotizing infection of the genital area, with high morbidity and mortality. The site of infection its the origin of the necrotizing fasciitis. There are 4 well known origins of Fournier's gangrene: Testicular, Intestinal, Urinary and cutaneous, and its prognostic value has not been established yet, that's because the lack of case series with adequate number of patients. This is a retrospective study in which we evaluate the prognostic factors of every patient and its mortality compared with its origin area and multiple scores with their survival rates and hospital stay.

NCT ID: NCT03147352 Completed - Clinical trials for Necrotizing Soft Tissue Infection

Prognosis and Treatment of Necrotizing Soft Tissue Infections: A Prospective Cohort Study

ProTreat
Start date: February 2013
Phase:
Study type: Observational [Patient Registry]

The investigators will analyze biomarkers related to the prognosis and treatment of necrotizing soft tissue infections (NSTI). The focus will be on whether certain endothelial and immune system biomarkers can function as markers of disease severity, mortality as well as the effects of hyperbaric oxygen therapy (HBOT). Biomarkers will be measured upon admission to an intensive care unit at Copenhagen University Hospital and during the following 3 days.

NCT ID: NCT02501382 Completed - Clinical trials for Necrotizing Soft Tissue Infection

Modulation of Biomarkers in Patients With Flesh-eating Bacterial Infections After With Hyperbaric Oxygen Treatment

BIONEC-II
Start date: February 2013
Phase:
Study type: Observational

The purpose of this study is to investigate the effects of hyperic oxygen treatment on the immune response in patients with necrotizing soft tissue infections

NCT ID: NCT02469857 Completed - Clinical trials for Necrotizing Fasciitis

Phase III Efficacy and Safety Study of AB103 in the Treatment of Patients With Necrotizing Soft Tissue Infections

ACCUTE
Start date: December 1, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether AB103 is safe and effective in the treatment of patients with necrotizing soft tissue infections (NSTI) receiving standard of care therapy.

NCT ID: NCT02180906 Completed - Clinical trials for Necrotizing Soft Tissue Infection

Biomarkers in Patients With Flesh-eating Bacterial Infections

BIONEC
Start date: February 2013
Phase: N/A
Study type: Observational

The purpose of this study is to investigate the immune response in patients with necrotizing soft tissue infections (NSTI). The investigation will focus on inflammatory and vasoactive biomarkers as prognostic markers of severity and mortality at admission to Rigshospitalet and the following 3 days

NCT ID: NCT02111161 Completed - Clinical trials for Necrotizing Soft Tissue Infection

Immunoglobulin for Necrotizing Soft Tissue Infections: a Randomised Controlled Trial

INSTINCT
Start date: April 2014
Phase: Phase 2
Study type: Interventional

The purpose of this study is to estimate the effect of intravenous polyspecific immunoglobulin G (IVIG) compared with placebo (saline) on the patient-reported outcome measure Physical Component Summary Score (PCS) of the SF-36 in patients with necrotizing soft tissue infections (NSTI).

NCT ID: NCT00261807 Completed - Fournier's Gangrene Clinical Trials

Daptomycin for the Treatment of Severe Necrotizing Soft-Tissue Infections

Start date: June 2005
Phase: N/A
Study type: Interventional

Daptomycin is a new antimicrobial agent which has activity against resistant Gram positive cocci including MRSA. The phase 3 clinical trials for skin and soft tissue infections (SSTI) with Staphylococci and Streptococci have already demonstrated that daptomycin was noninferior to the comparator agent (vancomycin or beta-lactams) (10). Although this clinical trial did not include any patients with clostridial infection, there is in vitro data to support the activity of daptomycin against a variety of clostridial species(11) ( Clostridium perfringens) Therefore, for this trial we will include patients with clostridial infections with this species. Additionally, the patients in the SSTI study were not as ill as the proposed study population. Therefore for treatment of such severe infections, we would like to use a higher dose of daptomycin (6mg/kg/dose). The reasons for using a higher dose of daptomycin in this subgroup are as follows: 1. Patients who are severely ill have an increased volume of distribution; and therefore have a lower serum concentration of daptomycin. These patients might require a higher dose of daptomycin to achieve the desired serum concentration. 2. One of the organisms involved in necrotizing fasciitis is enterococcus (both-fecalis and faecium). E.faecium has higher MICs to daptomycin and would require a higher dose of the drug to achieve adequate free (unbound) serum concentration of the drug. 3. Both necrotizing fasciitis and endocarditis are serious deep seated infections. The clinical trials for endocarditis are using 6mg/kg/dose of daptomycin. Therefore for optimal treatment of necrotizing fasciitis, it is justifiable that we should use the higher dose of daptomycin. Objective: To evaluate the clinical and microbiological efficacy and safety of higher dose daptomycin therapy in the treatment of patients with severe necrotizing skin and soft tissue infections. Type of Study: Open label, single center study.