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NCT ID: NCT02326467 Completed - Infection Clinical Trials

Pilot Study: Safety of Chlorhexidine (CHG) Baths in Patients Less Than 2 Months of Age

Start date: February 2016
Phase: Phase 1
Study type: Interventional

Literature provides overwhelming evidence supporting the use of chlorhexidine gluconate (CHG) a rapid onset, broad spectrum, topical antiseptic for reducing healthcare-associated infections (HAIs). CHG is believed to be superior to other forms of antiseptics because, when it is applied to the skin surface, it leaves a lasting residue on the skin. CHG has been shown to be well tolerated in patients 2 months of age and older. However there is limited evidence to support the use of topically applied CHG in infants less than 2 months of age because of potential safety concerns in this population. The purpose of this study will be to describe the safety of bi-weekly CHG baths in a sample of Newborn Intensive Care Unit (NICU) and pediatric Cardiac Intensive Care Unit (CICU) patients by measuring the incidence of skin problems and CHG blood levels.

NCT ID: NCT02325791 Completed - Clinical trials for Respiratory Syncytial Virus Infections

Study to Evaluate the Efficacy and Safety of Suptavumab (REGN2222) for the Prevention of Medically Attended RSV (Respiratory Syncytial Virus) Infection in Preterm Infants

Start date: July 21, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study was to evaluate the efficacy, safety, pharmacokinetics (PK), and immunogenicity of suptavumab (REGN2222) in infants born no more than 35 weeks, 6 days gestational age who are no more than 6 months of age at the time of enrollment in their respective geographic location. In order to optimize the potential benefit in this vulnerable population, we conducted this study during the RSV season using dosing regimens that are expected to be effective.

NCT ID: NCT02321800 Completed - Clinical trials for Urinary Tract Infections

A Study of Efficacy and Safety of Intravenous Cefiderocol (S-649266) Versus Imipenem/Cilastatin in Complicated Urinary Tract Infections

APEKS-cUTI
Start date: February 5, 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study was to determine the efficacy and safety of intravenous cefiderocol (S-649266) in hospitalized adults with complicated urinary tract infections caused by Gram-negative pathogens.

NCT ID: NCT02319772 Completed - Clinical trials for Ebola Virus Infection

A Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of BCX4430

Start date: December 2014
Phase: Phase 1
Study type: Interventional

This is a 2-part, first-in-human dose-ranging study to evaluate the safety, tolerability and pharmacokinetics of escalating doses of BCX4430 administered via intramuscular (IM) injection in healthy subjects. In part 1, subjects will receive a single dose of BCX4430; in part 2 subjects will receive BCX4430 for 7 days.

NCT ID: NCT02318147 Recruiting - Acute Pancreatitis Clinical Trials

Fecal Microbiota Transplantation for Pancreatitis With Infectious Complications(FMTPIC)

Start date: November 2016
Phase: Phase 1
Study type: Interventional

Infectious complications are responsible for most of deaths in acute pancreatitis.Intestinal barrier dysfunction and increased intestinal permeability was associated with bacterial translocation which is believed to prompted these infections.The purpose of this clinical trail is to observe the potential capability of FMT in reduce the bacterial translocation and alleviate infectious complications by the reconstruction of a gut functional state.

NCT ID: NCT02316444 Completed - Clinical trials for HIV/AIDS and Infections

Strategies for the Prevention of Hepatitis B Among HIV Infected Patients in Uganda

Start date: November 2015
Phase: Phase 4
Study type: Interventional

The aim of this study is to compare the effectiveness of two vaccination strategies against Hepatitis B virus (HBV) in subjects already infected with human immunodeficiency virus (HIV). Researchers plan to determine the optimal vaccination strategy for achieving protective immunity to HBV infection in HIV-infected adults attending Mulago Hospital's HIV care clinic. Primary objectives are to assess: 1. The role of CD4-cell count and HIV viral loads on the HBV vaccine response. 2. The role of highly active antiretroviral therapy (HAART) on the HBV vaccine response. The secondary objective is to evaluate whether lack of HAART is associated with high rates of loss to follow-up.

NCT ID: NCT02313857 Completed - CMV Infections Clinical Trials

Most Closely Human Leukocyte Antigen (HLA)-Matched CMV-specific T Lymphocytes (Viralym-C)

Start date: September 2015
Phase: Phase 1
Study type: Interventional

Patients enrolled on this study will have received a stem cell transplant. After a transplant, while the immune system grows back the patient is at risk for infection. Some viruses can stay in the body for life, and if the immune system is weakened (like after a transplant), they can cause life-threatening infections. CMV can cause serious infections in patients with weak or suppressed immune systems. It usually affects the lungs, causing a very serious pneumonia, but it can also affect the gut, the liver and the eyes. Investigators want to see if they can use a kind of white blood cell called T cells to treat CMV infections that occur after a transplant. Investigators have observed in other studies that treatment with specially trained T cells has been successful when the cells are made from the transplant donor. However as it takes 1-2 months to make the cells, that approach is not practical when a patient already has an infection. Investigators have now generated CMV-specific T cells from the blood of healthy donors and created a bank of these cells. Investigators have previously successfully used frozen virus-specific T cell lines generated from healthy donors to treat virus infections after bone marrow transplant, and have now improved the production method and customized the bank of lines to specifically and exclusively target CMV. In this study, investigators want to find out if the banked CMV-specific T cells derived from healthy donors are safe and can help to treat CMV infection. The CMV-specific T cells (Viralym-C) are an investigational product not approved by the Food and Drug Administration (FDA).

NCT ID: NCT02313844 Withdrawn - BK Virus Infection Clinical Trials

Most Closely Human Leukocyte Antigen (HLA)-Matched BK Virus-specific T Lymphocytes (Viralym-B)

Start date: March 1, 2018
Phase: Phase 1
Study type: Interventional

Patients enrolled on this study will have received a stem cell transplant. After a transplant, while the immune system grows back the patient is at risk for infection. Some viruses can stay in the body for life, and if the immune system is weakened (like after a transplant), they can cause life-threatening infections. BK virus (BKV) is a virus that can cause serious life-threatening infections in patients who have weak immune systems. It affects the urinary tract, and can cause frequent urination, blood in the urine, and severe pain. Investigators want to see if they can use a kind of white blood cell called T cells to treat BKV infections that occur after a transplant. Investigators have observed in other studies that treatment with specially trained T cells has been successful when the cells are made from the transplant donor. However as it takes 1-2 months to make the cells, that approach is not practical when a patient already has an infection. Investigators have now generated BKV-specific T cells from the blood of healthy donors and created a bank of these cells. Investigators have previously successfully used frozen virus-specific T cell lines generated from healthy donors to treat virus infections after bone marrow transplant, and have now improved the production method and customized the bank of lines to specifically and exclusively target BKV. In this study, investigators want to find out if the banked BKV-specific T cells derived from healthy donors are safe and can help to treat BK virus infection. The BKV-specific T cells (Viralym-B) are an investigational product not approved by the Food and Drug Administration (FDA).

NCT ID: NCT02313532 Not yet recruiting - Clinical trials for Febrile Illness Acute

Treatment of Febrile Infectious Disease Among Children in Hadera District Given the Final Diagnosis. Descriptive Study

Start date: January 2015
Phase: N/A
Study type: Observational

Study goal - to describe pediatric patients with febrile disease that administered to the emergency department (ED) of hillel-yaffe hospital, according to arrival diagnosis, ED diagnosis, given therapy, and therapy concordance with the guidelines and final diagnosis. This research will describe cases that arrived to the hospital with acute febrile disease (up to seven days of fever), the antibiotic treatment given in the community according to the anamnesis and the community physician letter, therapy concordance with the guidelines, the ED diagnosis and changes in therapy, and final diagnosis according to extended microbiological examinations and panel of infectious disease specialists.

NCT ID: NCT02312986 Completed - Clinical trials for Infection With Multi-drug Resistant Organisms

FMT for Multidrug Resistant Organism Reversal

Start date: August 2015
Phase: Phase 1
Study type: Interventional

This proposed protocol involves the use of the fecal microbiota transplantation (FMT) to suppress or reverse colonization with multidrug resistant organisms (MDRO) in subjects with recurrent MDRO infections due to organisms of likely enteric origin. FMT will be performed on subjects with a history of at least three recurrent infections due to MDRO; at least two recurrent, severe infections due to MDRO requiring hospitalization; or at least two recurrent infections due to MDRO for which only antimicrobials with rate limiting toxicities are available. The objective of this protocol is to determine if fecal microbiota transplantation (FMT) will be able to prevent additional recurrences of infections due to MDRO by suppressing or reversing enteric colonization with MDRO.