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Infections clinical trials

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NCT ID: NCT03840148 Completed - Clinical trials for Urinary Tract Infections

Safety and Efficacy Study of Cefepime/VNRX-5133 in Patients With Complicated Urinary Tract Infections

CERTAIN-1
Start date: August 7, 2019
Phase: Phase 3
Study type: Interventional

This study will assess the safety and efficacy of cefepime/VNRX-5133 compared with meropenem in both eradication of bacteria and in symptomatic response in patients with cUTIs.

NCT ID: NCT03839914 Recruiting - Trauma Clinical Trials

Evaluating the Efficacy and Safety of Intra-wound Vancomycin Powder in High Risk Patients

Start date: August 1, 2020
Phase: N/A
Study type: Interventional

Surgical site infections (SSI) are not uncommon, especially in specific high-risk groups including spinal deformity and tumor (i.e. metastatic spine surgery) surgery. Well-recognized measures have been adopted to reduce surgical site infection, and the use of topical vancomycin powder has gained popularity in recent years. Given the lack of high-quality evidence for the use of topical vancomycin to reduce surgical site infections in open posterior spine surgery, which is currently the most common approach to spine surgery, it is crucial to study the use of vancomycin powder in reducing surgical site infections. This study is a prospective, single-blinded open label randomized controlled trial, with one arm of patients having local administration of 1g vancomycin powder which will be placed in the deep wound and subcutaneous layer prior to closure of surgical site by the orthopaedic surgeon, whereas the control arm will be without such application of vancomycin. Both arms of patients will still be undergoing the same operation procedures, as well as postoperative local wound drainage and wound care. This study will provide insights on the reduction rate in superficial and/or deep surgical site infection, and also assess the cost-effectiveness of using topical vancomycin in reducing surgical site infection between different disease groups, as well as any postoperative serum vancomycin toxicity and renal impairment. These proposed findings will provide valuable information for clinicians and institutions on future measures for surgical site infection of open posterior spine surgery.

NCT ID: NCT03838575 Recruiting - Surgery Clinical Trials

ROSSINI 2 - Reduction of Surgical Site Infection Using Several Novel Interventions

ROSSINI 2
Start date: March 1, 2019
Phase: Phase 3
Study type: Interventional

ROSSINI 2 is a phase III, multi-arm, multi-stage (MAMS) pragmatic, blinded (patient and outcome assessor), multicentre, randomised controlled trial (RCT) with an internal pilot, to evaluate the use of several in-theatre interventions, used alone or in combination, to reduce SSI rates in patients undergoing surgery.

NCT ID: NCT03837756 Completed - HIV-1-infection Clinical Trials

Combining TLR9 Agonist With bNAbs for Reservoir Reduction and Immunological Control of HIV

TITAN
Start date: May 6, 2019
Phase: Phase 2
Study type: Interventional

This study is designed to evaluate the safety and efficacy of lefitolimod and 3BNC117/10-1074 in HIV-1-infected individuals on ART and during ATI as intervention to reduce the HIV-1 reservoir

NCT ID: NCT03837015 Completed - HIV-1-infection Clinical Trials

Estrogen, Probiotics and Vaginal Health to Prevent HIV Infection in ACB Women

Start date: November 4, 2019
Phase: Phase 1
Study type: Interventional

This study will enrol African, Caribbean and Black (ACB) women who are known to have a more diverse vaginal microbiome, higher rates of bacterial vaginosis with lower numbers of protective lactobacilli, and are at increased risk for HIV. The investigators will evaluate the safety, feasibility, effect on the vaginal bacterial microbiome and changes in local immune and inflammatory responses with the administration of vaginal estrogen alone, vaginal estrogen in combination with oral or vaginally administered probiotics, or vaginal probiotics alone.

NCT ID: NCT03835546 Completed - Clinical trials for Cognitive Impairment

Study to Assess the ART Impact on the Brain Outcomes. The ARBRE Study

ARBRE
Start date: October 26, 2015
Phase:
Study type: Observational

The ARBRE Study is an observational prospective trial aimed at investigating the impact of the therapy initiation with INTIs on brain outcomes according to the time of therapy initiation. Three study arms are considered: 1) Early treated HIV-1 infected patients (<3 months since estimated date of infection), 2) Regularly treated HIV-1 infected patients (>6 months since estimated date of infection), 3) Matched seronegative control group. Study assessments will be performed at baseline, 1 month and 12 months. Study assessments will comprise comprehensive evaluation of brain outcomes. They will include cognitive functioning, neuroimaging parameters, and functional outcomes.

NCT ID: NCT03830333 Completed - Clinical trials for Complicated Intra-abdominal Infections

Ceftolozane/Tazobactam (MK-7625A) Plus Metronidazole Versus Meropenem for Participants With Complicated Intra-abdominal Infection (MK-7625A-015)

7625ACNPhase3
Start date: March 20, 2019
Phase: Phase 3
Study type: Interventional

This study aims to evaluate the efficacy of ceftolozane/tazobactam (MK-7625A) plus metronidazole versus meropenem in adults diagnosed with complicated intra-abdominal infection (cIAI). The primary hypothesis is ceftolozane/tazobactam plus metronidazole is non-inferior to meropenem, as measured by the clinical response rate at the Test-of Cure (TOC) visit in the Clinically Evaluable (CE) population.

NCT ID: NCT03829475 Active, not recruiting - Clinical trials for Inflammatory Bowel Diseases

ICON-2: FMT and Bezlotoxumab Compared to FMT and Placebo for Patients With IBD and CDI

ICON-2
Start date: January 1, 2020
Phase: Phase 2
Study type: Interventional

This is a randomized controlled trial to assess the clinical and microbiological impacts of FMT in combination with Bezlotoxumab (bezlo) compared to FMT in combination with placebo in patients with both inflammatory bowel disease (IBD) a and clostridium difficile infection (CDI). The investigators will prospectively enroll up to 150 IBD-CDI patients from 4 tertiary care FMT referral centers. Patients will be randomized 1:1 to either receive FMT in combination with Bezlo of FMT and a placebo infusion. Donor stool from healthy donors will be obtained from OpenBiome. OpenBiome is a nonprofit 501(c)(3) organization that provides hospitals with screened, filtered, and frozen material ready for clinical use. Patients will be enrolled and followed prospectively for 3 months post therapy. Stool and blood samples as well as clinical data will be collected at baseline, week 1, 8 and 12.

NCT ID: NCT03827694 Recruiting - Clinical trials for Pulmonary Invasive Aspergillosis

Non-Invasive Diagnosis of Pediatric Pulmonary Invasive Mold Infections

DOMINIC
Start date: October 30, 2018
Phase:
Study type: Observational

This study will establish a non-invasive diagnostic approach and evaluate clinical outcomes for children at high-risk for pulmonary invasive fungal infection (PIFI).

NCT ID: NCT03826342 Active, not recruiting - Drug Use Clinical Trials

Technology-Based Intervention for Reducing Sexually Transmitted Infections and Substance Use During Pregnancy

Start date: April 16, 2019
Phase: N/A
Study type: Interventional

This proposed study is to test whether Health Check-up for Expectant Moms (HCEM), a computer-delivered screening and brief intervention (SBI) that simultaneously targets sexually transmitted infection (STI) risk and alcohol/drug use during pregnancy, reduces antenatal and postpartum risk more than an attention, time, and information matched control condition among pregnant women seeking prenatal care.