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Communicable Diseases clinical trials

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NCT ID: NCT03558984 Terminated - Cardiac Surgery Clinical Trials

D-PLEX 302: Efficacy and Safety of D-PLEX in the Prevention of Sternal Infection Post Cardiac Surgery

Start date: December 17, 2019
Phase: Phase 3
Study type: Interventional

Prospective, Multinational, Multicenter, Randomized, Parallel Controlled, Two arms, Single Blind, Study to Assess the Efficacy and Safety of D-PLEX Administered Concomitantly with the Standard of Care (SOC) IV Prophylactic Antibiotic Treatment vs. SOC in Prevention of Post-Cardiac Surgery Sternal Infections. Study to assess D-PLEX efficacy and safety in preventing sternal infections over a period of 90 days (3 months) post cardiac surgery with median sternotomy, in patients with high risk for infection compared to the control arm.

NCT ID: NCT03558438 Active, not recruiting - HIV Infections Clinical Trials

Spanish Cohort of Patients With HIV Infection Older Than 50 Years for the Study of Fragility and Physical Function

FUNCFRAIL
Start date: May 7, 2018
Phase:
Study type: Observational

It's a prospective observational study to assess frailty and physical function

NCT ID: NCT03557840 Recruiting - Infection Clinical Trials

Plasma Protein Binding and PK/PD of Total and Unbound Temocillin Non-ICU Patients

TEMODELTA
Start date: April 1, 2019
Phase: N/A
Study type: Interventional

Multidrug resistance towards Gram-negative pathogens makes essential the re-examination of older compounds. Temocillin is a penicillin originally marketed in the 1980s but then largely abandoned. It, however, shows a marked ß-lactamase stability (including most classical and extended-spectrum TEM, SHV, CTX-M enzymes and AmpC ß-lactamase). Temocillin is approved for the treatment of bacterial infections of the chest, the lungs, the kidney, the bladder, as well as bacterial infections of the bloodstream and wound infections. Temocillin efficacy depends primarily from the time interval during which the unbound plasma concentration remains above the minimal inhibitory concentration (MIC) of the antibiotic against the target organism(s). Unfortunately, no comprehensive pharmacokinetic data are available in non-critically-ill patients. The primary objective of the study is characterize the pharmacokinetics of total and unbound temocillin in non-ICU patients, and, on this basis, to propose optimized dosage regimens in this population. The secondary objectives are (i) to look for possible correlations between the plasma protein profile and the unbound temocillin concentrations; (ii) to investigate the impact of the level and nature of circulating plasma proteins on the unbound temocillin concentration. The study will be non-randomized, uncontrolled, prospective, open label, interventional, and monocentric. It will include a population pharmacokinetic-pharmacodynamic analysis of the data obtained. The study will enroll patients ≥ 18 years in need of a treatment with temocillin for (i) complicated urinary tract infection and pyelonephritis (associated or not with bacteremia), or (ii) lower respiratory tract infection, or (iii) abdominal infection, and requiring ≥ 4 days of hospitalization. Blood samples will be obtained at day 0 (control) and after 2 and 4 days of drug treatment (full pharmacokinetic evaluation over 8 to 12 h post-administration). Total and unbound temocillin concentrations in plasma will be quantified by a validated analytical method. A population pharmacokinetic/pharmacodynamics model of plasma total and unbound concentrations of temocillin will be obtained by Bayesian algorithms using Pmetrics software, driven by the predicted plasma total and unbound concentration. The model will be used to assess the probability of target attainment of temocillin.

NCT ID: NCT03556488 Recruiting - Pneumonia Clinical Trials

Ultrasonographic Air Bronchogram in Pediatric CAP

USINCHILD
Start date: May 21, 2018
Phase:
Study type: Observational

This study evaluates the prognostic role of the change of arborescent air bronchogram, a typical ultrasonographic finding of lung consolidation due to pneumonia, in the management of pediatric CAP.

NCT ID: NCT03551847 Withdrawn - Infection Clinical Trials

The Effect of Oral Antibiotics on Synovial Fluid and Differential for the Diagnosis of Infection

Start date: July 1, 2011
Phase: N/A
Study type: Interventional

Periprosthetic joint infection following total hip or knee arthroplasty is a rare but potentially devastating complication. Accurate diagnosis of these infections remains one of the most challenging undertakings in orthopaedics. Multiple studies have shown the high diagnostic accuracy of synovial fluid white blood cell count (WBC) and neutrophil percentage (%PMNs) in detecting PJI. This study's goal is to evaluate how antibiotics affect those two important diagnostic measures.

NCT ID: NCT03551561 Completed - Infection Clinical Trials

Measures for the Prevention of Surgical Site Infection

Orthopedics
Start date: June 30, 2017
Phase: N/A
Study type: Interventional

Among the causes associated with infection of hospitalized patients, surgical site infection is a complication that is potentially associated with any type of surgical procedure, it also represents an expressive burden in terms of morbidity and mortality, as well as additional costs for health care systems around the world. It is regarded that the efficiency of the pre, per, and postoperative skin preparation depends on both the adopted antiseptic and the application method, with Chlorhexidine currently being the most used drug in such preparation. However, the manner, timing, or timing of cutaneous antisepsis action is unclear. Objective: Comparing antisepsis techniques using chlorhexidine-based soap associated with ethyl alcohol and alcoholic chlorhexidine versus chlorhexidine-based soap associated with alcoholic chlorhexidine, in surgical orthopedic procedures.

NCT ID: NCT03550911 Recruiting - Joint Infection Clinical Trials

Biological Collection From Samples From The Gut Microbiota In Patients Having A Bone Or Joint Infection Treated By A Suppressive Subcutaneous Antibiotherapy With Betalactamine (CARBAMICROBIOTA)

Start date: October 11, 2018
Phase:
Study type: Observational

Optimal surgical therapy (debridement in chronic osteomyelitis; device exchange in patients with chronic prosthetic joint infection (PJI)) could be sometimes non-feasible, especially in the elderly population. Therefore, a medical therapy with oral prolonged suppressive antibiotic therapy (PSAT) seems to be an option to prevent recurrence and prosthesis loosening. Unfortunately, some patients are infected with resistant pathogens for which oral antibiotics are not suitable. Subcutaneous (SC) administration of injectable intravenous antibiotics as prolonged suppressive antibiotic therapy could be a convenient way to limit catheter-related complications and facilitate ambulatory care. However, there are few data concerning the development of resistance under subcutaneous prolonged treatment with betalactamine. The aim of this study is just to constitute a biological collection from samples from the Gut microbiota in patients having a bone or joint infection treated by a suppressive subcutaneous antibiotherapy with betalactamine. Later analysis will be led on those samples to detect the acquisition of resistance or not.

NCT ID: NCT03549702 Completed - Clinical trials for Surgical Site Infection

Subcutaneous Tissue Irrigation With Povidone Iodine in Decreasing the Rate of Surgical Site Infection Following Cesarean Section

Start date: January 1, 2017
Phase: N/A
Study type: Interventional

This study aims to assess the efficacy of Povidone Iodine (Betadine®) irrigation of subcutaneous tissue prior to skin closure in reducing the incidence of surgical site infection after elective caesarean section and post discharge.

NCT ID: NCT03549312 Recruiting - HIV/AIDS Clinical Trials

Switch to Genvoya Followed by HCV Therapy With Epclusa Followed by Simplification of HIV Therapy With Biktarvy in Patients With HIV-HCV Co-Infected Subjects on Opioid Substitution Therapy

Start date: February 1, 2018
Phase: Phase 4
Study type: Interventional

The study hypothesis is to determine the feasibility of switching HIV-HCV co-infected patients receiving methadone or buprenorphine/naloxone as opioid substitution therapy with suppressed HIV RNA viral load on current antiretroviral therapy to elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF, Genvoya™) followed by 12 weeks of HCV antiviral therapy with sofosbuvir/velpatasvir (SOF/VEL, Epclusa™), followed then by switch to bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF, Biktarvy™) for an additional 48 weeks.

NCT ID: NCT03548740 Recruiting - Clinical trials for Papillomavirus Infections

Diversity Analysis of Vaginal Microbiota on Women With High-risk Human Papillomavirus Infection

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

Since other genital infections enhance HIV susceptibility by inducing inflammation, the investigators study the relationship between the vaginal microbiota composition and the risk of HPV infection, cervical cytological abnormalities.