Treatment Trials

34 Clinical Trials for Various Conditions

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COMPLETED
Trial of 2% Chlorhexidine Bathing on Nosocomial Infections in the Surgical Intensive Care Unit
Description

This prospective, randomized, controlled trial will compare the incidence of nosocomial infections (composite of primary bloodstream infections, catheter-associated urinary tract infections, ventilator-associated pneumonia, and surgical site infections) that occur in intensive care unit (ICU) patients bathed with 2% chlorhexidine solution versus patients who receive standard bathing (soap and water or non-medicated cloths).

UNKNOWN
Study of Talactoferrin Oral Solution for Nosocomial Infection in Preterm Infants
Description

This study will evaluate the safety, toxicity and efficacy of talactoferrin in reducing the incidence of all nosocomial infections in prematurely-born infants.

COMPLETED
Potential Nosocomial Infection Prevention Via Modification of Anesthesia Intraoperative Aseptic Practice
Description

We hypothesized that by improving hand hygiene compliance in the operative environment, we would reduce horizontal transmission of pathogenic bacteria to surgical patients.

COMPLETED
Study of Bathing With Chlorhexidine Impregnated Cloths on Nosocomial Infections in the Pediatric Intensive Care Unit
Description

The investigators propose to conduct a large clinical study to determine if daily bathing with chlorhexidine impregnated cloths will reduce the incidence of healthcare-associated infections in the Pediatric Intensive Care Unit (PICU).

UNKNOWN
Multicenter Trial of Daily Chlorhexidine Bathing to Reduce Nosocomial Infections
Description

To determine if daily bathing with chlorhexidine impregnated washcloths will reduce the incidence of MRSA and VRE within an Intensive Care Unit (ICU) or ward setting.

COMPLETED
The Impact of Chlorhexidine-Based Bathing on Nosocomial Infections
Description

The purpose of this study was to determine if the use of daily chlorhexidine bathing would decrease the incidence of MRSA and VRE colonization and healthcare associated Bloodstream Infections (BSI) among Intensive Care Unit (ICU) patients.

COMPLETED
Evaluation of Body-worn Multimodal Hand Hygiene System. Impact on Health-Care Associated Infections
Description

Evaluate the efficacy of a multimodal hand hygiene system in the intensive care unit environment and evaluate any impact on health care associated infections.

COMPLETED
ED Residents MBP During CVC Placement: Sim Lab Based Training
Description

1. Baseline performance in maximal barrier precaution technique of Emergency Medicine (EM) residents, certified in CVC placement, is poor 2. Simulation-based training in maximal barrier precaution technique during central venous catheter (CVC) placement will improve baseline performance of EM residents

COMPLETED
Simulation-based Training for Surgery Residents in Aseptic Techniques
Description

Central line associated bloodstream infection (CL-ABI) is an important and preventable cause of nosocomial infections and is responsible for considerable morbidity and mortality The Centers for Disease Control have published guidelines for the prevention of CL-ABI that represent a collaborative effort by a multidisciplinary coalition of professional organizations that provide evidence based recommendations to prevent catheter related infections \[5\]. The interventions emphasize five distinct practices, including: education and training of healthcare providers who place and care for catheters, utilizing maximum sterile barrier precautions during catheter placement.

COMPLETED
Skin Cleansing With Chlorhexidine to Decrease Hospital Acquired Infections
Description

Patients in the intensive care unit are at risk for many infections because the severity of illness and the procedures necessary to care for them. This study is designed to look at a change in bathing procedure as a method to reduce infections. Currently, patients at John H. Stroger Hospital are cleansed with soap and water. However, preliminary data from a previous study at Rush University Medical Center showed that a chlorhexidine (CHG)-impregnated cloth (2% CHG Antiseptic Cloth system, Sage Products, Inc.) decreased skin bacteria and may lessen bacteria in the blood stream. The 2% CHG Antiseptic Cloth system is a non-irritating, no-rinse, cleansing and moisturizing product that contains 2% chlorhexidine gluconate. The goal of this proposed study is to further evaluate the effectiveness of the 2% CHG Antiseptic Cloth system compared with soap and water in cleansing the skin and preventing bacteria from entering the bloodstream.

COMPLETED
Safety and Efficacy of Veronate® Versus Placebo in Preventing Nosocomial Staphylococcal Sepsis in Premature Infants
Description

The purpose of this study is to show whether Veronate, a donor-selected staphylococcal human immune globulin intravenous (IGIV), can prevent an infection in the blood caused by staphylococcal bacteria in premature babies weighing between 500 and 1250 grams at birth. Babies are enrolled between Day of Life 3 and 5. Babies are randomized to either Veronate or placebo (50-50 chance of either). Babies can receive up to 4 doses of the study drug on Study Days 1, 3, 8 and 15 and are followed until Study Day 70 or discharge from the hospital.

COMPLETED
Red Light Photobiomodulation and Topical Disinfectants
Description

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.

COMPLETED
Nasal Photodisinfection in All Patients Presenting for Surgery for a Wide Range of Surgical Procedures
Description

This is a Phase 2 single-center, open-label, single-arm, study of a microbiological endpoint using antimicrobial photodynamic therapy (aPDT) for nasal disinfection in all patients (universal) presenting for surgery at an acute care hospital for a wide range of surgical procedures.

UNKNOWN
Association of Cytokines With the Development of Complications in Burn and Toxic Epidermal Necrolysis (TENS) Patients
Description

This study will involve blood draws to test for specific cytokines. The study goal is to gain a better understanding of the role of inflammatory response in the development of specific complications in burn and TENS patients.

COMPLETED
Inulin for Infections in the Intensive Care Unit
Description

Normal gut bacteria prevent colonization and subsequent infection with MDR organisms (MDROs) through competition for resources and other mechanisms. During critical illness, this function of the microbiome is lost and there are no current treatments to restore it. Preliminary data indicates that the prebiotic fiber inulin is safe and may alter the gastrointestinal microbiome to improve gut barrier function, decrease colonization with MDROs, and reduce downstream risk for intensive care unit (ICU)-acquired MDR infections. However, the impact of inulin during critical illness is unknown. This double-blind, randomized clinical trial will test inulin for the prevention of antibiotic resistant infections in the ICU. The trial's specific aims are to determine (1) the feasibility, tolerability, and safety of inulin in the intensive care unit; (2) the impact of inulin on gut colonization with antibiotic-resistant pathogens; and (2A/exploratory) the impact of inulin on ICU-acquired antibiotic-resistant infections.

TERMINATED
Preoperative Application of Chlorhexidine to Reduce Infection With Cesarean Section After Labor
Description

Surgical site infections (SSI) are the second most common cause of nosocomial infections accounting for 15% of all nosocomial infections among hospitalized patients and 38% of nosocomial infections in surgical patients. In obstetric patients, infectious morbidity (i.e. SSI, endometritis) occurs in 5-10% of cesarean sections, which is 5-fold higher than vaginal deliveries. Additionally, infectious morbidity is thought to be highest in those patients who have cesarean sections after undergoing labor. Chlorhexidine, a chemical antiseptic effective on gram positive and gram negative bacteria, reduces skin microflora/colonization but it is not clear if it decreases the risk of SSI. Historically, chlorhexidine has been studied and used in orthopedic and cardiac implant surgeries. Research on the use of chlorhexidine for SSI prevention in cesarean sections is limited. This study intends to evaluate the effectiveness of use of both chlorhexidine gluconate (CHG) wipe and vaginal scrub in reducing SSI in patients undergoing cesarean section that have previously been laboring. Patients will be randomized to one of two groups: wash with both a pre-operative CHG cloth prior to surgery and chlorhexidine gluconate vaginal scrub in addition to standard preoperative scrub as compared to standard preoperative scrub alone.

COMPLETED
Administration of Zepatier (Grazoprevir Plus Elbasvir) in Chronic Hemodialysis (HD) Patients With Hepatitis C
Description

This is a study to define strategies for Nephrologists to directly supervise and apply direct acting antivirals to cure hepatitis C in hemodialysis patients. Strategies will include identification of candidate patients, application for insurance approval, specifics of direct acting antiviral therapy (Zepatier with or without ribavirin) and laboratory monitoring during and after therapy.

COMPLETED
Decreasing Antibiotic Use in Infants With Suspected Ventilator-associated Infection
Description

This is a prospective study with three specific aims: (1) To convene a consensus conference to develop a guideline for antibiotic use in infants (age \< 3 yrs) with suspected ventilator-associated infection; (2) To evaluate outcomes before and after implementation of the antibiotic guideline; (3) To evaluate changes in the tracheal microbiome over the course of mechanical ventilation

TERMINATED
A Safety and Tolerability Study of Doripenem Compared With Cefepime in Hospitalized Children With Bacterial Pneumonia
Description

The purpose of this study is to evaluate the safety and tolerability of doripenem compared to cefepime in children hospitalized with pneumonia.

COMPLETED
VA Nutrition Study on Immune Function
Description

Hospital-acquired infections can occur five times as frequently in rehabilitation patients than in other hospital admissions. We postulate that this high infection rate may be due to nutritional problems frequently experienced in these patients. In this study, we examine the role of nutrition in inpatient geriatric rehabilitation patients' immune function and infection rates.

ENROLLING_BY_INVITATION
Studies of the Human Microbiome in Clinical Center Patients
Description

Background: - The intestines, mouth, and skin all contain billions of bacteria and some fungi. Every person s body contains microorganisms like these. They normally do not make people sick. Researchers are interested in how these microorganisms change when a person is hospitalized. They want to find out if changes take place because of the hospitalization (such as treatments used or changes in medical condition) or because of a person s biology (such as their immune system). Objectives: - To understand which microorganisms are most likely to spread through hospitals and what affects that spread. Eligibility: - People 2 years of age and older who are going to be inpatients at the National Institutes of Health Clinical Center (NIHCC) for at least 48 hours. Design: * Clinicians will take samples from participants up to once a day for as long as they are hospitalized at NIHCC. * Samples will be taken with a swab, from the rectal area, groin, throat, and armpit, and possibly other areas. * Participants may give a stool sample or be asked to spit into a cup. * Clinicians will collect some information from participants medical records. They may request some samples of tissue that are left over from procedures already scheduled at NIHCC. * After participants leave the NIHCC, samples may be taken when they return for follow-up visits from their hospitalization, for up to 2 years. They will not have to return as a follow-up for this study only.

COMPLETED
The Use of the Prevena™ Incision Management System on Post-Surgical Cesarean Section Incisions
Description

The purpose of this study is to compare the post-surgical standard-of-care dressing to the Prevena™ Incision Management System in women undergoing Cesarean section surgery.

COMPLETED
Vitamin D in Ventilated ICU Patients
Description

The increasing rate of hospital-acquired infection and antibiotic resistance are major causes of prolonged ICU stay and death in hospitalized patients. The enormous impact of ICU-related infection demands the need for cost-effective therapies that can be rapidly implemented to improve patient immune response to control infection. Unfortunately, little high-quality comparative effectiveness research has been performed on micronutrient treatment regimens as methods to decrease hospital-acquired infection in critically ill patients. Critically ill medical and surgical patients have an extremely high prevalence of vitamin D insufficiency. We will perform a rigorous, double-blind, randomized, controlled, pilot clinical trial in ventilator-dependent ICU patients to test the clinical/metabolic safety and efficacy of two doses of oral high-dose vitamin D3 therapy versus standard therapy (no supplemental vitamin D). The primary endpoint is to test whether high-dose regimens \[either 50,000 or 100,000 international units (IU) of enteral vitamin D3 given daily for 5 consecutive days (total dose = 250,000 or 500,000 IU, respectively) increase plasma 25(OH)D concentrations into a desirable range (\> 30 ng/mL).

COMPLETED
Impact of Gender on Hospitalized Patients
Description

The purpose of this study is to better understand the relationship between gender (being a man or a woman), infections caught in the hospital, and serious illness. Five hundred seventy patients 18 years of age or older who are critically (seriously) ill and admitted to the Intensive Care Unit (ICU) for at least 48 hours will participate in this study. Patients will be studied while receiving regular ICU treatment according to local standards. Blood specimens will come from patients either as wasted blood (University of Virginia) or blood collected from patients specifically for the study (Vanderbilt University). All patients will be followed daily until death or discharge from the ICU. The researchers believe that they will find a similar risk of infection for men and women overall.

COMPLETED
Study Comparing a Soybean Oil-Based With an Olive Oil-Based Lipid Emulsion in ICU Patients Requiring TPN
Description

Many hospitalized patients who are malnourished or not eating receive intravenous feeding or total parenteral nutrition (TPN). Despite improving nutrition, TPN may increase the risk of infections and hospital complications. We do not know why TPN increases hospital complications, but it may be caused by the high sugar or fat content in TPN solutions.

COMPLETED
Effect of Leukoreduced Blood Transfusions on Infection Following Trauma
Description

The purpose of this study is to determine if leukoreduced blood transfusions reduce the risk of infection following trauma. Specifically, the investigators intend to evaluate whether there are clinically relevant differences in the rates of infection and in the severity of multiple organ failure in critically injured trauma patients receiving leukoreduced blood products compared to those receiving standard allogeneic blood products.

COMPLETED
Management Practices and the Risk of Infection Following Cardiac Surgery
Description

The purpose of the study is to determine the best ways to prevent infections after heart surgery. Participation in the study will last at most 3 months after heart surgery. The study will only collect information about the care patients receive during the planned surgery. No new testing or procedures will be done. Patients will receive only the tests or procedures the doctor already has planned. This kind of study is an observational study, because all that is planned to do is observe the care patients receive and how well they do during treatment. The information collected should help to improve the quality of surgical care in the future.

COMPLETED
An Effectiveness, Safety, and Microbiology Study of Doripenem in Patients With Nosocomial (Hospital-acquired) Pneumonia
Description

The purpose of this study is to evaluate the effectiveness and safety of doripenem monohydrate in the treatment of patients with nosocomial (hospital-acquired) pneumonia.

COMPLETED
Strategies To Prevent Pneumonia 2 (SToPP2)
Description

Ventilator-associated pneumonia (VAP) is a serious complication in mechanically ventilated critically ill patients. The intervention tested in this project (swabbing the mouth with chlorhexidine before the endotracheal tube is inserted) could reduce the risk of ventilator-associated pneumonia.

COMPLETED
Ledipasvir/Sofosbuvir Fixed-Dose Combination in Adults With Nosocomial Genotype 1 HCV Infection
Description

This study is to evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in adults with nosocomial genotype 1 hepatitis C virus (HCV) infection.

Conditions