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NCT ID: NCT01581047 Completed - Infection Clinical Trials

Pharmacokinetics of Small Spectrum Beta-lactam Antibiotics (Amoxicillin/Clavulanic Acid and Cefuroxime) in Patients on Intensive Care Units

AMOCEF
Start date: March 15, 2012
Phase:
Study type: Observational

Adequate antibiotic therapy is very important in the treatment of infections. Spectrum and dosing of the antibiotics are two factors of the therapy: the spectrum of an antibiotic can't be changed, but the dosing scheme can be optimized. Recent studies proved that an optimized dosing scheme can improve the efficacy of the treatment. Broad-spectrum antibiotics have unpredictable pharmacokinetics in patients on intensive care units. This is due to the pathophysiologic processes in the patients on intensive care units: increased distribution volume, hypoproteinemia, organ failure… The investigators guess that similar processes influence the pharmacokinetics of small spectrum antibiotics (like amoxicillin and cefuroxime), but data lacks. Because the pharmacokinetics of broad spectrum antibiotics in seriously ill patients are better known, physicians are more confident prescribing these drugs. Studying the pharmacokinetic interactions of small spectrum antibiotics in seriously ill patients, can help to give the physician the confidence to prescribe these small-spectrum antibiotics. In this study, the investigators will study the pharmacokinetics of amoxicillin/clavulanic acid and cefuroxime, in 60 patients on intensive care. 8 blood samples will be drawn via a central catheter on different moments after one administration of the antibiotic in the steady state phase. All the patients are prescribed the antibiotics for the treatment of their infections: they get the antibiotic therapy anyway. By measuring the concentrations on different moments after one administration, the investigators can reconstruct the pharmacokinetic function.

NCT ID: NCT01580137 Active, not recruiting - Clinical trials for Acute Upper Respiratory Tract Infection and Acute Bacterial Rhinosinusitis

Acute Upper Respiratory Tract Infection - When is Bacteria Involved?

Start date: February 2012
Phase: N/A
Study type: Observational

The purpose of this study is to find out if we can predict the progress of acute upper respiratory tract infection to acute bacterial rhinosinusitis in Finnish conscripts by symptoms, clinical, endoscopic or radiological findings, middle meatal swab samples or nitric oxide measurement.

NCT ID: NCT01579370 Completed - Clinical trials for Healthcare Associated Infections

Effectiveness of Enhanced Terminal Room Disinfection to Prevent Healthcare-associated Infections (HAIs)

Start date: April 2012
Phase: N/A
Study type: Interventional

Enhanced terminal room disinfection is a novel, promising, but still unproven strategy for the prevention of healthcare-associated infections (HAIs) due to selected multidrug-resistant (MDR) bacterial pathogens. The investigators will perform a large prospective, multicenter study enhanced terminal room disinfection to 1) determine the efficacy and feasibility of enhanced terminal room disinfection strategies to prevent HAIs and 2) determine the impact of environmental contamination on acquisition of MDR-pathogens among hospitalized patients.

NCT ID: NCT01577862 Completed - Clinical trials for Pneumonia, Ventilator-Associated

Colistin and Rifampicin for MDR-Acinetobacter

CoRAb
Start date: November 2008
Phase: Phase 3
Study type: Interventional

Acinetobacter baumannii causes severe infections (pneumonia, bacteremia, organ space) with high lethality in hospitalised critically ill patients. It can acquire resistance to all classes of antibiotics (multidrug resistance, MDR) except an 'old' drug, colistin, which may be the only therapeutic option. However, colistin is not registered for this indication. The addition of rifampicin to colistin has been shown to be synergistic in vitro, and may be promising in vivo, but this combination has not been studied in comparison with colistin alone. The purpose of this randomised, open-label, multicentre clinical trial is to assess whether the association of colistin and rifampicin reduces significantly the mortality of patients with severe MDR A. baumannii infections compared with colistin alone. The trial will enroll 210 patients from intensive care units (ICU) of five tertiary care hospitals where MDR A. baumannii infection is endemic with epidemic phases. Patients will be randomly allocated to either colistin alone (control arm) or colistin plus rifampicin (experimental arm). Primary end point is overall mortality, defined as death occurring within 30 days from randomisation. Secondary end points will be disease-specific death, microbiological eradication, hospitalization length, emergence of resistance to colistin during treatment.

NCT ID: NCT01576809 Completed - Clinical trials for Upper Respiratory Infections

Warming Sensation Intensity and Acceptability of the Flavour, Local Tolerability of Paracetamol 500 mg + Phenylephrine 10mg + Guaifenesin 200 mg Syrup in Patients Suffering a Upper Respiratory Tract Infection (URTI)

Start date: March 2012
Phase: Phase 3
Study type: Interventional

This is an open label, in-use study to assess the warming sensation, acceptability and local tolerability of paracetamol 500 mg + phenylephrine 10mg + Guaifenesin 200 mg syrup, given as a single dose in subjects suffering from symptoms of an upper respiratory tract infection. The purpose is to evaluate the acceptability concerning a warming sensation effect and its potential benefit in the target population. The primary objective is to assess the warming sensation caused by the excipient IFF flavor 316 282, in a syrup containing paracetamol 500 mg + phenylephrine 10mg + Guaifenesin 200 mg per 30 ml syrup. The syrup contains (0.15% w/v) warming flavor. The Secondary Objectives are to assess subject acceptability of the syrup and the safety and tolerability of the syrup. The study will be run in fifty-six (56) subjects suffering from symptoms of an upper respiratory tract infection (URTI) for 7 days or less, e.g. nasal congestion associated with colds and flu symptoms such as pain, headache and/or fever. Subjects must have one or more symptoms per category: 1. mild to moderate body pain, headache, fever or sore throat 2. nasal congestion (blocked nose) with or without rhinorrhea (runny nose) or sneezing 3. productive cough Adolescents will be included in the study population

NCT ID: NCT01576003 Completed - Nutrition Clinical Trials

Enteral Glutamine in Reducing Bloodstream Infections in Short Bowel Syndrome Infants

Start date: April 2012
Phase: N/A
Study type: Interventional

The purpose of this research study is to evaluate the effects (good and bad) of supplementation with Glutamine to that of a placebo (L-alanine), on your child and their Short Bowel Syndrome. Researchers are doing this study to see if the addition of Glutamine to oral/tube feeding (nutrition therapy) will work better by preventing bloodstream infections, improving growth, and/or changing the make-up of bacteria in your child's intestine. Glutamine is approved by the FDA for use in adults with Short Bowel Syndrome. In this study, the investigators will be assessing how well Glutamine affects Short Bowel Syndrome in children.

NCT ID: NCT01575938 Completed - Clinical trials for Sexual Transmission of Infection

HIV Prevention Intervention for Young Transgender Women

LifeSkills
Start date: March 2012
Phase: N/A
Study type: Interventional

The purpose of this study is to test the efficacy of a uniquely targeted HIV risk reduction intervention for young transgender women (YTW), ages 16 to 29, at risk for HIV acquisition or transmission.

NCT ID: NCT01572831 Completed - Infection Clinical Trials

PCT and Clinical Algorithm for Determination of Duration of Antibiotics

Start date: May 2012
Phase: Phase 3
Study type: Interventional

Patients in the ICU whose infection is resolving will be randomized to standard duration of antibiotics compared to duration determined by a combination of a procalcitonin value and a simple evaluation of clinical status.

NCT ID: NCT01572233 Recruiting - Clinical trials for Hepatitis C Virus Infection, Response to Therapy of

Effects of Activity and Education Program on Patients With Chronic Hepatitis C Infection

Start date: December 2011
Phase: N/A
Study type: Interventional

This 4-year project will be guided by a biobehavioral model for the study of exercise interventions in two phases with the purposes to : 1. explore the patients' physical activity preferences and develop doable activity lists during treatment period 2. examine the changes of health-related physical fitness component over interferon treatment 3. develop the Personalized Physical Activity and Psych-Education (PPAPE) Program and test its effects on decreasing fatigue, physical and psychological distress, and improving their health-related physical fitness and quality of life in patients with chronic hepatitis C receiving Interferon with Ribavirin Combination Therapy 4. evaluate the outcome of the PPAPE program on increasing adherence to therapy, the sustained virological response (SVR) in 24 weeks after the end of treatment, and the time-consuming for education program during intervention.

NCT ID: NCT01571583 Completed - Clinical trials for Chronic Hepatitis C Virus (HCV) Infection

An Efficacy and Safety Study of Telaprevir in Patients With Genotype 1 Hepatitis C Infection After Liver Transplantation

REPLACE
Start date: February 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the effectiveness of telaprevir in combination with Peg-IFN-alfa-2a and ribavirin in stable liver transplant patients with chronic hepatitis C virus (HCV) genotype 1.