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Bacterial Infection clinical trials

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NCT ID: NCT01800396 Completed - Diarrhea Clinical Trials

Milk Ingredients and Resistance Against E-coli-induced GastroEnteritis (MIRAGE)

MIRAGE
Start date: February 2013
Phase: N/A
Study type: Interventional

Background: The incidence of gastrointestinal infections is very high. In Western countries at least 30% of the population suffers from at least one food-borne infection per year. Mostly because of the problem of antibiotic resistance, more emphasis is put on prevention of infections. One of the possibilities is to strengthen human resistance to gut infections by consumption of milk ingredients. Aim: To study whether a milk protein concentrate rich in phospholipids improves the resistance of humans to enterotoxigenic E. coli (ETEC). Study design: The MIRAGE study is a parallel, double-blind, placebo-controlled 4-weeks intervention with a milk protein concentrate rich in phospholipids in healthy subjects of 18-55 yrs of age. Participants will be randomly assigned to the milk protein concentrate rich in phospholipids or placebo group (n=30 per group). Subjects will be instructed to maintain their usual pattern of physical activity and their habitual food intake, but to standardize their dietary calcium intake. After an adaptation period of 2 weeks, subjects will be orally infected with a live, but attenuated, ETEC vaccine (strain E1392-75-2A; collection NIZO food research; dose will be 1010 CFU). Before and after infection, an online diary will be kept to record all food and drinks consumption (2x2 days) to assess the habitual dietary intake. The diary will also be used for daily recording of bowel habits and frequency and severity of gastrointestinal complaints. The following biological samples will be collected: 4x10 ml venous blood, a single fecal bolus (for screening) and 7x24 hrs feces. Blood is sampled for immune response analyses and the fecal samples are collected to quantify several infection- and immune system markers and to verify dietary calcium intake. Saliva is sampled three times before and after infection to quantify immune system markers. Primary outcomes: Fecal ETEC excretion and severity of diarrhea (quantified by fecal output per day). Secondary outcomes: Serum immune response to ETEC, self-reported stool consistency scores and gastrointestinal complaints, relative fecal wet weight.

NCT ID: NCT01709266 Completed - Diarrhea Clinical Trials

The Effect of Probiotics on E. Coli-induced Gastroenteritis

PROTETEC
Start date: August 2012
Phase: N/A
Study type: Interventional

Background: The incidence of gastrointestinal infections is very high. In Western countries at least 30% of the population suffers from at least one food-borne infection per year. Mostly because of the problem of antibiotic resistance, more emphasis is put on prevention of infections. One of the possibilities is to strengthen human resistance to gut infections by consumption of probiotics. A specific blend of probiotic lactic acid bacteria (Lactobacillus helveticus Rosell-52, Lactobacillus rhamnosus Rosell-11, Bifidobacterium longum Rosell-175) and a probiotic yeast (Saccharomyces boulardii), improved stool consistency and shortened the duration of diarrhea in a rat model of E.coli-induced diarrhea. These probiotics showed synergistic effects compared with administration of solely S. boulardii or a mixture of L. helveticus Rosell-52, L. rhamnosus Rosell-11, B. longum Rosell-175. Consumption of S. boulardii and a combination of L. helveticus Rosell-52, L. rhamnosus Rosell-11 reduced diarrhea in humans. Aim: To study whether probiotics improves the resistance of humans to enterotoxigenic E. coli (ETEC). Study design: The PROTETEC study is a parallel, double-blind, placebo-controlled 4-weeks intervention with probiotics in healthy volunteers. In this study, the effect of probiotic intervention vs placebo on several infection markers in response to an ETEC challenge is investigated. Participants will be randomly assigned to the probiotic or placebo group (n=30 per group). Subjects will be instructed to maintain their usual pattern of physical activity and their habitual food intake, but to standardize their dietary calcium intake. After an adaptation period of 2 weeks, subjects will be orally infected with a live, but attenuated, ETEC vaccine (strain E1392-75-2A; collection NIZO food research; dose 10E10 CFU). Before and after infection, a diary will be kept to record all food and drinks consumption (2x2 days) to assess the habitual dietary intake, as well as for daily recording of bowel habits and frequency and severity of gastrointestinal complaints. The following biological samples will be collected: 4x10 ml venous blood, a single fecal bolus (for screening) and 7x24 hrs feces. Blood is sampled for immune response analyses and the fecal samples are collected to quantify several infection- and immune system markers, to determine probiotic excretion, and to verify dietary calcium intake. Study population: Healthy males of 20-55 yrs of age. Interventions: Probiotics (capsules containing freeze-dried powder, probiotic dose per capsule 5x10E9 CFU; twice daily) or placebo (capsules with carrier material powder of identical appearance) Primary outcomes: Fecal ETEC excretion and severity of diarrhea (quantified by fecal output per day). Secondary outcomes: Serum immune response to ETEC, self-reported stool consistency scores and gastrointestinal complaints, relative fecal wet weight. Tertiary outcomes: sIgA and calprotectin in feces, probiotic persistence and levels of opportunistic pathogens in the endogenous microbiota.

NCT ID: NCT01611740 Completed - Bacterial Infection Clinical Trials

Contribution of Real Time Analyses of CARdio-RESpiratory Signals to the Diagnosis of Infection in PREterM Infants

CARESS_PREMI
Start date: May 2012
Phase:
Study type: Observational

Hospital-acquired infections are common complications in preterm infants. The diagnosis has to be fast and accurate. Indeed, the early identification of a suspected infection is very important, since the early administration of antibiotics lowers the risk of septic shock and improves long term outcome in the infected newborns who survive. Besides, a high specificity in the diagnosis of infection allows for the reduction of inappropriate treatment and thus prevents the emergence of antibiotic resistance. The aim of this study is to develop a computer-assisted diagnosis tool, based on the real time analysis of cardio-respiratory signals, to aid the neonatologist in the diagnosis of infection of the preterm infant, at the bedside.

NCT ID: NCT01485705 Completed - Bacterial Infection Clinical Trials

Retrospective Examination of Initial Care of Severe Bacterial Infections of the Child

Diabact
Start date: August 13, 2009
Phase: N/A
Study type: Interventional

The aim of the study is to determine the frequency of sub-optimal care in the initial care (before arrival at the intensive care unit) of children from "West France regions" suffering of severe bacterial infections.The characteristic "optimal or not" of the initial medical care will be determined by 2 independent experts, blinded from each other and blinded from the issue of the care. In case of a discordance between the two experts, a third expert will be demanded. Three possibilities of conclusion will be proposed to the experts: "sure sub-optimal medical care", "possible suboptimal care" and "optimal care".

NCT ID: NCT01446289 Completed - Bacterial Infection Clinical Trials

Immune Response Induced by a Vaccine Against Group B Streptococcus and Safety in Pregnant Women and Their Offsprings

Start date: September 2011
Phase: Phase 2
Study type: Interventional

The study investigated the immune response induced by the Group B streptococcus vaccine in healthy pregnant women. In addition, the study investigated the amount of vaccine induced antibodies which were transferred to the newborn.

NCT ID: NCT01371656 Completed - Diarrhea Clinical Trials

Levofloxacin in Preventing Infection in Young Patients With Acute Leukemia Receiving Chemotherapy or Undergoing Stem Cell Transplantation

Start date: September 2011
Phase: Phase 3
Study type: Interventional

This randomized phase III trial studies how well levofloxacin works in preventing infection in young patients with acute leukemia receiving chemotherapy or undergoing stem cell transplant. Giving antibiotics may be effective in preventing or controlling early infection in patients receiving chemotherapy or undergoing stem cell transplant for acute leukemia. It is not yet known whether levofloxacin is effective in preventing infection.

NCT ID: NCT01289249 Completed - Bacterial Infection Clinical Trials

Meropenem Plasma Concentration Measurements at the Pediatric Medical Ward, Oslo University Hospital, Rikshospitalet

Start date: January 2011
Phase: N/A
Study type: Observational

The object of the study is to investigate whether all included patients receive treatment that is effective against all bacteria that are defined as sensitive to meropenem with the current treatment regimen. Will the investigators findings motivate routine monitoring of plasma concentrations in children receiving meropenem? Up to 50 patients will be included in the study, and all participants are children.

NCT ID: NCT01271998 Completed - Bacterial Infection Clinical Trials

Pulmonary Disposition of TR-700 Following Once-Daily Oral 200 mg

Start date: December 8, 2010
Phase: Phase 1
Study type: Interventional

The primary purpose of this study is to determine the steady-state plasma pharmacokinetics (PK) and properties of TR-700 into the pulmonary epithelial lining fluid (ELF) and alveolar macrophages (AM) of healthy volunteers.

NCT ID: NCT01250574 Completed - Bacterial Infection Clinical Trials

Neutrophil CD64 and Procalcitonin as Novel Biomarkers for Postoperative Infections

Start date: November 2010
Phase:
Study type: Observational

Postoperative complications, especially bacterial infections, are relatively common and cause increased morbidity and mortality. Effective and timely antimicrobial treatment is important for prognosis, and delayed diagnosis and treatment substantially increase mortality. The early diagnosis of infection and sepsis are today based on diagnostic tests that have been available for years, like WBC count, SR and CRP. These markers suffer from several drawbacks; their sensitivity and specificity for infection and sepsis are not good enough and their kinetics are rather slow in terms of both increase and decrease. A major disadvantage of CRP is that after surgery and trauma this marker generally increases for several days, reaching a plateau typically on day 2-4 following the event, and therefore, in most cases do not offer the needed guidance for early treatment of bacterial infection. More recently, other biomarkers for infection and sepsis have become available, some of which appear acceptable for diagnostic use. Procalcitonin (PCT) and neutrophil CD64 are both promising new markers for the early detection of infection. They do both have their pros and cons compared to each other and compared to the traditional markers, such as CRP and WBC count. It is a general view that further research is needed before these markers will be accepted as part of the routine protocol for the diagnosis of infections, especially in relation to postoperative complications. The aim of the present study is to investigate the clinical utility of procalcitonin (PCT) and neutrophil CD64 as markers for infection and inflammation: - to evaluate if it is possible to detect early phase postoperative infections by using these tests versus traditional markers such as CRP, SR and WBC count (with differential). - to differentiate between systemic bacterial infection and systemic inflammation due to the surgical trauma. The hypothesis is that PCT and neutrophil CD64 are more sensitive and specific analysis for the early detection of infection after abdominal surgery than CRP (and other widely used tests for inflammation and infection), and that neutrophil CD64 is more specific than PCT. Patients admitted to the Department of Gastroenterological Surgery, Akershus University Hospital for elective abdominal surgery will be included in the study after informed consent. Initially consecutive series of 150 patients will be included, but this number may be increased depending on the number of observed infections during the course of the study. All patients will be monitored and treated by the formal protocol related to clinical signs of infection, such as abcess, peritonitis, pneumonia, sepsis and septic shock. In addition to the analytical parameters routinely used today in order to discover infections (CRP, WBC count etc), blood samples for PCT and neutrophil CD64 will be analyzed before surgery and daily during the stay at the hospital. In the case of signs of infection, locally or systemic, the frequencies of analysing PCT and CD64 will be increased according to the severity of the changes in the clinical condition. The expression of CD64 will be measured by flow-cytometry and PCT will be measured by an immunochemical method.

NCT ID: NCT01244698 Completed - Bacterial Infection Clinical Trials

Postoperative Antibiotic Requirements Following Immediate Breast Reconstruction

Start date: November 2010
Phase: Phase 4
Study type: Interventional

Antibiotics are used routinely in postoperative tissue expander based breast reconstruction (TE) and autologous flap (AF) breast reconstruction procedures. Closed suction drains are also used routinely in immediate breast reconstruction to prevent fluid accumulation and seroma formation at the surgical sites. Antibiotics are most often prescribed as a precaution since drains can be a source for infection by creating open channels to outside contaminants. Plastic surgery patients without closed suction drainage devices are usually not placed on prolonged postoperative antibiotics. Current preoperative surgical antibiotic prophylaxis is recommended for up to 24 hours only. These recommendations do not take into account the increased risk of indwelling closed suction drains. A recent survey of plastic surgeons, conducted by SBUMC investigators, (IRB# 129415) found that Plastic Surgeons are divided as to extended outpatient administration following TE breast reconstruction. The study plans to prospectively enroll patients who will undergo immediate breast reconstruction with TE or AF based breast reconstruction. Using the above data and the current protocol, the investigators will investigate the optimal antibiotic discontinuation period for these patients. The investigators hypothesize that the use of 24-hour perioperative antibiotics in TE or AF based immediate breast reconstruction with closed suction drainage, does not result in an increased infection rate compared to prolonged postoperative antibiotic administration.