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NCT ID: NCT00491985 Completed - Influenza Clinical Trials

Safety and Immunogenicity of 2 Formulations of an Intramuscular A/H5N1 Pandemic Influenza Vaccine in Children

Start date: June 2007
Phase: Phase 2
Study type: Interventional

This is an open, randomized, multicenter clinical trial. Objectives: - To describe the safety profiles during the 21 days following each primary and booster injection. - To describe the immune response 21 days after each primary and booster injection of each formulation. - To describe the antibody persistence after the first vaccination

NCT ID: NCT00491426 Completed - Infection Clinical Trials

Antimicrobial PK in Infants With Suspected or Confirmed Infection

Start date: January 2006
Phase: Phase 1
Study type: Observational

The purpose of this protocol is to provide a mechanism for the ongoing collection of blood and urine samples in newborns that will be used to measure levels of antimicrobial products used in the newborn population where there are limited pharmacokinetic data in either premature or term infants.

NCT ID: NCT00491335 Completed - HIV Infections Clinical Trials

HIV Infection and Tobacco Use Among Injection Drug Users in Baltimore, Maryland: A Pilot Study of Biomarkers

Start date: June 18, 2007
Phase: N/A
Study type: Observational

Background: The incidence of lung cancer is quite high among people with the human immunodeficiency (HIV) virus. Frequent smoking may explain that cancer increase, given that 50% to 70% of HIV-infected people are current smokers. Recent research suggests that other factors may be involved as well. Smoking habits, such as smoking earlier in life or smoking more cigarettes a day than others do, may have a role. Also, HIV-infected smokers seem to have a greater risk of chronic obstructive pulmonary disease (COPD). The association of HIV and COPD is important, because COPD itself is linked to an increased risk of lung cancer. About 1,600 subjects from the study known as ALIVE (AIDS Linked to the Intra-Venous Experience), which began in 1988 in Baltimore, Maryland, will be given a detailed questionnaire on smoking behaviors and lung cancer risk factors. They will also have spirometry testing, to evaluate lung function. Objectives: To better characterize smoking habits and compare tobacco use among HIV-infected and uninfected drug users. To compare serum cotinine levels and spirometry results, as a marker of tobacco use and a marker of damage to lung function, respectively. Eligibility: Patients 18 years of age and older who are in the ALIVE cohort. Design: Patients undergo the following procedures: - Completing a questionnaire on smoking history. Questions include age when smoking began, periods of quitting smoking, average number of cigarettes per day for specific periods, amount of each cigarette smoked, depth of inhalation, type of cigarette, nicotine dependence, use of other smoked [Note: I would not mention that these drugs are illegal] drugs, exposure to environmental tobacco smoke, past medical history, and recent respiratory symptoms. - Spirometry testing. Patients are asked to breathe as deeply as possible and then rapidly exhale into a tube. The forced expiration volume in 1 second reflects the average flow rate during the first second, and it can be used to determine the degree of pulmonary obstruction. - Blood samples. Tests measure levels of cotinine, a chemical made by the body from nicotine. African American males, who constitute the majority of the ALIVE cohort, participate in this test. Results would show how much tobacco smoke has recently entered the body. For this test, researchers plan to evaluate 240 current tobacco smokers and 100 participants who report no recent cigarette use.

NCT ID: NCT00490412 Completed - HIV Infections Clinical Trials

Vitamin D Reabsorption in Adolescents and Young Adults With HIV Infection

Start date: December 2007
Phase: N/A
Study type: Interventional

The purpose of this study is to test the effects of Vitamin D on renal phosphate and bone loss, which are common in HIV infected adolescents and young adults being treated with tenofovir.

NCT ID: NCT00489619 Completed - Pregnancy Clinical Trials

Safe Pregnancy by Infectious Disease Control

Start date: April 2004
Phase: N/A
Study type: Observational

Malaria and sexually transmitted infections (STIs) are common in pregnant women in Africa and are important preventable causes of poor birth outcomes and maternal and infant mortality. This study investigated baseline characteristics of the population including: rates of STIs including HIV, prevalence of malaria and tuberculosis (TB) and resistance to common antimalarial drugs.

NCT ID: NCT00488761 Completed - Clinical trials for Skin Diseases, Infectious

Study Evaluating the Safety and Efficacy of Tigecycline in Hospitalized Patients With cSSSI

Start date: July 2006
Phase: Phase 4
Study type: Interventional

Tigecycline's activity against resistant organisms, as well as significant coverage of both gram-positive and gram-negative bacteria, may provide a valuable therapeutic alternative in treating patients with complicated skin and/or skin structure infections.

NCT ID: NCT00488488 Completed - Infection Clinical Trials

A Pharmacovigilance Evaluation And Assessment Of The Prescribing Practice For Tygacil In Usual Health Care Setting

Start date: November 2006
Phase: N/A
Study type: Observational

To assess the efficacy and safety of Tygacil in the usual German hospital setting. The main goals are: to assess the efficacy of Tygacil under usual care conditions (cure rate); to assess the main side effects observed in daily medical practice (Safety of Tygacil); to determine whether patients are optimally dosed with Tygacil (according to the label) and the proportion of patients receiving a monotherapy versus combination therapy; to observe the potential resistance development against Tygacil in Germany; to determine which antibiotic agents are chosen for a combination therapy with Tygacil; to determine to which antibiotic substance non-responders to Tygacil are switched; to assess the duration of the intravenous therapy with Tygacil and to determine whether and which patients receive an oral antibiotic substance after the therapy with Tygacil; to collect information on profile, comorbidities and characteristics of patients treated with Tygacil.

NCT ID: NCT00488345 Completed - Clinical trials for Bacterial Infections

Study Evaluating the Pharmacokinetics (PK), Safety, and Tolerability of Tigecycline in Patients 8 to 11 Years of Age

Start date: December 2007
Phase: Phase 2
Study type: Interventional

To determine the pharmacokinetic profile and to evaluate the safety and tolerability of ascending multiple doses of tigecycline in patients aged 8 to 11 years with selected serious infections; complicated intra-abdominal infections (cIAI), complicated skin and skin structure infections (cSSSI), or community-acquired pneumonia (CAP).

NCT ID: NCT00484952 Not yet recruiting - Clinical trials for Rotavirus Infections

Surveillance of Hospitalizations Due to Rotavirus Infections Among Children From Israel

Start date: September 2007
Phase: N/A
Study type: Observational

Objectives 1. To determine the burden and characteristics of rotavirus-associated hospitalizations among children under five years of age of northern Israel 2. To identify potential risk factors of rotavirus infections associated with hospitalizations among Jewish and Arab children younger than five years of age. Methods: Study design: A two-year prospective study and a nested case control study will be carried out Collection of data: Questionnaires will be filled in with demographic characteristics of patients and data on the clinical manifestation of the diarrheal episode leading to hospitalization. Stool specimens will be systematically collected from all children hospitalized because of diarrheal diseases and examined for rotavirus and for bacterial and protozoan enteropathogens. Positive samples for rotavirus will be tested for G and P genotypes. For the nested case control study additional data will be obtained from parents' interviews on variables such as: parents' education, parents' age, parents' occupation, no. of siblings, age of siblings, breastfeeding etc. to identify potential risk factors for rotavirus diarrhea necessitating hospitalization. Data analysis: Methods of descriptive statistics / epidemiology will be applied to determine the characteristics of the burden of rotavirus-associated hospitalizations (the distribution of diarrhea associated hospitalizations by etiology, rates of rotavirus diarrheal diseases in Jewish and Arab children, age specific rates of rotavirus infections, the percentage of hospitalizations due to rotavirus diarrhea by month, etc. For the nested case control study, univariate analysis will be first performed using Student t test for continuous variables and chi square test for categorical variables to study the statistical significance of predictive factors of rotavirus diarrheal diseases necessitating hospitalization. Multivariate analysis using logistic regression models will be performed to study the independent effect of each variable. Odds ratios (OR) and 95% CI will be computed for each variable. Two tailed p < 0.05 will be considered significant.

NCT ID: NCT00484627 Completed - HIV Infections Clinical Trials

Effects of Creatine and Resistance Exercise Training in People With HIV Infection

Start date: August 2001
Phase: Phase 2
Study type: Interventional

This study was designed determine whether use of creatine monohydrate, a dietary supplement, can increase skeletal muscle mass and strength and improve the response to progressive resistance exercise training in people with HIV infection.