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Bacterial Infection clinical trials

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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.

NCT ID: NCT01225042 Completed - Diarrhea Clinical Trials

The Effect of Probiotics on E. Coli Gastroenteritis

PRETEC
Start date: October 2010
Phase: N/A
Study type: Interventional

Background: The incidence of gastrointestinal infections is very high. In European countries 10-25% of the population suffers from at least one foodborne infection per year. Probiotics may strengthen human resistance to gut infections as they may beneficially modulate the intestinal microbiota composition and activity, and the immune function upon intestinal infection. Aim: To study whether probiotics improve the resistance of humans to enterotoxigenic E. coli (ETEC). Study design: The PRETEC study is a parallel, double-blind, placebo-controled 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=21 per group). Subjects will be instructed to maintain 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 10E10 CFU). This ETEC strain induces mild and short-lived infectious diarrhea symptoms. Before and after infection, a diary will be kept to write down 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. Blood is sampled for immune response analyses and multiple faecal 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 (freeze-dried powder, dose 10E9 CFU twice daily) or placebo (carrier material powder of identical appearance). Primary outcomes: Total fecal ETEC excretion per day and severity of diarrhea (quantified by faecal output per day). Secondary outcomes: Serum immune response to ETEC, self-reported stool consistency scores and gastrointestinal complaints, relative faecal wet weight, sIgA and calprotectin in faeces, probiotic persistence and levels of opportunistic pathogens in the endogenous microbiota.

NCT ID: NCT01173575 Completed - Bacterial Infection Clinical Trials

Assessment of the Efficacy of FOSFOMYCIN in Patients With Bacterial Infection

Start date: August 2010
Phase:
Study type: Observational

This project aims to assess the clinical and microbiological efficacy of fosfomycin(FOM) in patients with bacterial infection. Primary objective: • To assess clinical and microbiological efficacy of FOM in patients with bacterial infection. Secondary objectives: - To determine the rate and severity of unexpected adverse events. - To determine the mean duration of therapy with FOM in patients with bacterial infection. Study design: Multi-center, non-interventional study

NCT ID: NCT01156077 Completed - Bacterial Infection Clinical Trials

Pharmacokinetic (PK) Study of Oral and IV TR-701 FA in Adolescent Patients

Start date: June 2, 2010
Phase: Phase 1
Study type: Interventional

This is an open-label, multi-center, two-part, parallel-design study to assess the PK, safety, and tolerability of TR-701 FA and its active metabolite, TR-700, following a single oral dose (Part A) or IV dose (Part B) of TR-701 FA in 12 to 17 year old adolescent patients.

NCT ID: NCT01059890 Completed - Brain Injury Clinical Trials

Cerebral Antibiotics Distribution After Acute Brain Injury

Start date: September 2009
Phase: Phase 1
Study type: Interventional

The aim of the study is to explore the distribution of antibiotics in the brain after an acute brain injury because brain infections treatment is still an health care problem.

NCT ID: NCT01012089 Completed - Clinical trials for Chronic Kidney Disease

Study of the Pharmacokinetics of Daptomycin in Children With Renal Disease

Start date: November 2009
Phase: N/A
Study type: Interventional

The purpose of this study is to: 1. Study the pharmacokinetics and safety of daptomycin in children on hemodialysis (HD) and peritoneal dialysis (PD). 2. Determine urine, HD and PD clearance of daptomycin.

NCT ID: NCT00939562 Completed - Bacterial Infection Clinical Trials

Bioequivalence Between Two Tablet Formulations Of Doxycycline Carragenate

Start date: November 2008
Phase: Phase 4
Study type: Interventional

The purpose of this protocol is to study if two different tablet formulations of doxycycline are bioequivalent to each other.

NCT ID: NCT00915213 Completed - Bacterial Infection Clinical Trials

Incidence of Antibiotic Resistant E.Coli in Patients Undergoing Repeat Prostate Biopsy

Start date: October 2008
Phase: N/A
Study type: Observational

The purpose of this study is to discover how often certain bacteria are found in the rectum at the time of a prostate needle biopsy to diagnose prostate cancer. Certain bacteria are of importance because they can cause serious infection. Antibiotics that urologists commonly use to prevent these bacteria from causing infection are no longer effective. Many physicians around the world are noting increased infections with antibiotic resistant bacteria. Therefore; despite treating patients who are to undergo prostate biopsy with antibiotics, certain patients are being readmitted to the hospital with a serious infection. In order to study the incidence of these particular bacteria, the best method is to culture the bacteria at the time of the biopsy. This involves one rectal culture swab just prior to needle biopsy of the prostate. Once the incidence of these bacteria is known we may take steps to prevent the serious infections that occur as a result of prostate biopsy.

NCT ID: NCT00800488 Completed - Fever Clinical Trials

Procalcitonin for Predicting Serious Bacterial Infection in Infants Less Than 3 Months

PRONOUR
Start date: October 2008
Phase: N/A
Study type: Observational

The primary objective is to study the value of serum procalcitonin as a predictive marker for severe bacterial infection in febrile infants. 2200 febrile infants aged less than 3 months will prospectively be included. All infants will have a measure of Procalcitonin concentrations. Comparison of the mean value of Procalcitonin concentration in infants with and without serious Bacterial infection. Evaluation of the area under the ROC for Procalcitonin concentration.

NCT ID: NCT00760279 Completed - Bacterial Infection Clinical Trials

An Open Label Evaluation of the Pharmacokinetics and Safety of Single Dose Intravenous Azithromycin in Preterm Neonates

Start date: September 2005
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the pharmacokinetics and safety of a single dose of IV azithromycin in preterm neonates and confirm that the pharmacokinetics of azithromycin is similar in the 24-<32 week and 32-<37 week neonate. The dose of 10 mg/kg has been chosen on the basis of previous pediatric pharmacokinetic studies.