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NCT ID: NCT02126930 Completed - Infection Clinical Trials

Pharmaceutical Consultation at Hospital Discharge and Adherence to Anti-infective Treatment

CPS-INFECTIO
Start date: November 2014
Phase: N/A
Study type: Interventional

The main objective of this study is to evaluate the impact of a pharmaceutical consultation at the time of hospital discharge on the adherence of patients ; non-adherence is determined by the following criteria: As concerns prescribed anti-infectious treatments, at least one of the following 4 criteria is true: 1. . the patient did not go and get his/her treatment at the pharmacy; 2. . the number of treatment units dispensed by the pharmacy is < the number of treatment units prescribed; 3. . the patient stopped taking a treatment before the recommended time, or continued taking a treatment after the recommended time; 4. . the number of treatment units taken by the patient (self-declaration) is < or > to the number of units prescribed.

NCT ID: NCT02124096 Completed - Influenza Clinical Trials

Zoonotic Influenza Infections of Swine Origin at Ohio Agricultural Fairs

Start date: April 25, 2014
Phase:
Study type: Observational

Background: - The flu is a very infectious and contagious virus that affects both people and pigs. Studies show that pigs can be sources of the flu virus in humans. Researchers want to know more about how the flu is transmitted from animals to people. If they know more about it, they can find better ways to prevent the flu and treat people who get sick from it. Objective: - To discover if flu viruses can be found in people exposed to pigs at Ohio agricultural fairs. Eligibility: - Volunteers 8 years of age and older who exhibit pigs at Ohio agricultural fairs. Design: - Before or on the first day of the fair, participants will fill out a short demographic and medical history form. They will also complete a two-page symptom questionnaire. This is a form that asks them about any flu symptoms they might have. - Participants will have a nasal swab performed. The inside of the participant s nose will be rubbed with a swab to collect nasal fluid. - Researchers will see participants 2 days later and 4 days later. During these visits, participants will again fill out a symptom questionnaire and have a nasal swab.

NCT ID: NCT02123433 Completed - HIV Infection Clinical Trials

Serological Response to Antipneumococcal Vaccination and Impact on Streptococcus Pneumoniae Nasal Carriage in HIV Adults

PCV13HIV2011
Start date: December 2011
Phase: Phase 3
Study type: Interventional

S. pneumoniae is frequently isolated from nasal swabs of healthy subjects, but it can also cause severe diseases (pneumonia, bacteraemia, meningitis and sepsis).HIV-infected subjects are more sensitive to invasive diseases and recurrent infection than the general population. Nasal carriage is the main pathogenetic feature for invasive disease: bacteraemia is more frequent in carriers, HIV+ patients are constantly colonized by the same pneumococcal strain and their nasopharyngeal isolates have features similar to subsequent invasive strains. A 23-valent polysaccharide vaccine (PPV23) has long been available and recommended in the HIV+ population as prophylaxis for invasive disease. Studies regarding efficacy of PPV23 in HIV+ are controversial and highlight that immune response induced by PPV23 in HIV+ is poor and an hyporesponsiveness to repeated polysaccaridic antigens stimulation can occur. Moreover, PPV23 seems not to affect pneumococcal carriage status and could lead to emergence of non-vaccine serotypes. The conjugation of pneumococcal capsular polysaccharides to carrier proteins results in an improved T-cell dependent immune response, characterized by increased antibody concentrations and induction of T and B memory cells, with a demonstrated higher efficacy in children. A heptavalent vaccine conjugated with diphtheria toxoid (PCV7) is approved in Europe since 2001 and is effective in reducing incidence of invasive disease by vaccine serotypes (4, 6B, 9V, 14, 18C, 19F, 23F), in both children and adults, due to effect of herd immunity. A PCV13 formulation has recently been developed, covering PCV7 serotypes plus 1, 3, 5, 6A, 7F and 19A. PCV13 revealed the same safety profile as PCV7 in pediatric patients, that are the main target of conjugate vaccines licensure. Some trials showed a better antibody response in terms of quantity and quality in HIV + adults by using PCV7 as compared to PPV23. However these data were not unequivocally confirmed in further studies on the use of PCV7 alone or in combination with PPV23. The first trials of PCV13 use in adults showed the same or even better response compared to PPV23, with a safety and tolerability similar to PCV7. PCV13 in HIV+ adults is a promising candidate prophylactic measure for pneumococcal infections. The purpose of this study is to evaluate serological response and prevalence of nasopharyngeal colonization by S. pneumoniae in HIV+ non-hospitalized adults, following vaccination with 2 doses of PCV13.

NCT ID: NCT02121938 Completed - Infection Clinical Trials

Dynamics of the Microbiome in the Premature Infant

Start date: April 2014
Phase:
Study type: Observational

The purpose of the study is to describe the dynamics of the microbiome in the premature infant as a means to adapt the premature infant gut to affect better health outcomes.

NCT ID: NCT02119754 Completed - Infection Clinical Trials

Topical PluroGel PN for the Treatment of Mildly Infected Diabetic Foot Ulcers

Start date: October 2013
Phase: Phase 2
Study type: Interventional

This is an open label study of subjects who have failed Protocol PGN-1300. Adult subjects (greater than 18 years old) who present with a mildly infected diabetic foot ulcer (IDSA criteria) having full thickness (i.e., through the dermis but not involving joint capsule, tendon, and bone) and have failed PGN-1300. Subjects must also provide informed consent and meet all other entry criteria to be enrolled and receive PluroGel PN.

NCT ID: NCT02116699 Completed - Infection Clinical Trials

Oropharyngeal Administration of Mother's Colostrum for Premature Infants (NS-72393-360)

Start date: November 20, 2013
Phase: N/A
Study type: Interventional

Extremely premature (BW<1250g) infants are at high risk for morbidity and mortality. Own mother's colostrum (OMC) and milk (OMM) protect against neonatal morbidity and are rich in immune factors which may provide immunostimulatory effects when administered oropharyngeally to extremely premature infants during the first weeks of life. The investigators hypothesize that infants who receive oropharyngeal mother's colostrum and milk will have significantly lower rates of infection and improved health outcomes, compared to infants who receive a placebo.

NCT ID: NCT02114177 Completed - Clinical trials for Hepatitis C Virus Infection

Efficacy and Safety Study of Simeprevir in Combination With Sofosbuvir in Participants With Chronic Hepatitis C Virus Infection Without Cirrhosis

Start date: April 2014
Phase: Phase 3
Study type: Interventional

The purpose of the study is to evaluate the efficacy and safety of a treatment regimen of 12 weeks or 8 weeks of simeprevir in combination with sofosbuvir in chronic hepatitis C virus (HCV) genotype 1 infected men and women without cirrhosis who are HCV treatment-naïve or treatment-experienced.

NCT ID: NCT02114151 Completed - Clinical trials for Hepatitis C Virus Infection

Efficacy and Safety Study of Simeprevir in Combination With Sofosbuvir in Participants With Genotype 1 Chronic Hepatitis C Virus Infection and Cirrhosis

Start date: April 2014
Phase: Phase 3
Study type: Interventional

The purpose of the study is to investigate the efficacy and safety of 12 weeks of simeprevir (150 mg qd) in combination with sofosbuvir (400 mg qd) in chronic hepatitis C virus (HCV) genotype 1 infected men and women with cirrhosis who are HCV treatment-naïve or treatment-experienced.

NCT ID: NCT02111564 Completed - Heart Failure Clinical Trials

A Study of Rivaroxaban (JNJ-39039039) on the Venous Thromboembolic Risk in Post-Hospital Discharge Patients

MARINER
Start date: January 7, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of rivaroxaban compared with placebo in the prevention of symptomatic venous thromboembolism (VTE) events and VTE-related death post-hospital discharge in high-risk, medically ill patients.

NCT ID: NCT02111161 Completed - Clinical trials for Necrotizing Soft Tissue Infection

Immunoglobulin for Necrotizing Soft Tissue Infections: a Randomised Controlled Trial

INSTINCT
Start date: April 2014
Phase: Phase 2
Study type: Interventional

The purpose of this study is to estimate the effect of intravenous polyspecific immunoglobulin G (IVIG) compared with placebo (saline) on the patient-reported outcome measure Physical Component Summary Score (PCS) of the SF-36 in patients with necrotizing soft tissue infections (NSTI).