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Infections clinical trials

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NCT ID: NCT01945307 Completed - Clinical trials for Complement Mediated Bacterial Killing in Healthy Adults

Complement 2: Blood Donations to Develop Vaccines Against Infectious Diseases

C2
Start date: October 2013
Phase:
Study type: Observational

We need human blood to understand the immune response to infection and to test promising new vaccines against infectious diseases in the laboratory. One test is called the Serum Bactericidal Assay (or SBA), which is measure of how effective antibodies are at killing certain bacteria and can be an important measure of how effective a new vaccine may be. The samples would be used in the laboratory analysis of clinical trials of vaccines used in adults and children, and some samples in pre-clinical (animal) experiments testing new vaccines before they enter human-stage testing. Most people have some form of protection against most bacteria already, so not everyone is a suitable blood donor for this laboratory test. We therefore start by taking a small blood sample and test this one before asking for more blood if we found yours suitable for the work we do.

NCT ID: NCT01940757 Recruiting - Hookworm Infection Clinical Trials

Experimental Infection of Hookworm-naïve Adults With Dermally-applied Infectious Necator Americanus Hookworm Larvae

Start date: January 2015
Phase: Phase 1
Study type: Interventional

An experimental hookworm infection model is being developed to provide early proof-of-concept that a hookworm vaccine targeting the blood-feeding pathway of adult hookworms is feasible and efficacious. The proposed model consists of vaccinating healthy, hookworm-naïve adults with a candidate hookworm vaccine, followed by challenging them with the investigational product, Necator americanus Larval Inoculum to assess the effect of vaccination on infection. The first proposed study will be a feasibility study that will consist of administering different doses of the Necator americanus Larval Inoculum to healthy adult volunteers to determine the optimal dose (i.e., number of infectious larvae) that is safe, well-tolerated and results in consistent infection.

NCT ID: NCT01935089 Completed - HIV-1 Infection Clinical Trials

Pilot Peg-Interferon-a2b in Decreasing Viral DNA in HIV

Start date: August 7, 2013
Phase: Phase 2
Study type: Interventional

We propose to test our primary hypothesis that treatment with Peg-IFN-α-2b will result in a decrease in integrated HIV DNA in peripheral blood and tissue in chronically HIV-infected immune-reconstituted individuals (see section 3.1) in a prospective, interventional, 1-arm, open label clinical trial. To this end, we propose to enroll 25 HIV-1-infected subjects (please refer to power calculations in section 10.1 below) currently stably suppressed (> 1y with VL < 50 copies/ml) on ART and with CD4 count > 450 cells/µl. We hypothesize that 20 weeks of treatment with Peg-IFN-alpha-2b, in the presence of HIV reactivation (i.e.: ART interruption), will result in activation of intrinsic and/or immune-mediated anti-HIV mechanisms resulting in a decrease in the levels of viral reservoir in chronically HIV-infected, immune-reconstituted individuals.

NCT ID: NCT01930955 Withdrawn - Clinical trials for Acute Upper Respiratory Tract Infection

Non-antibiotic Prescribing for Acute Upper Respiratory Tract Infection

Start date: August 1, 2011
Phase: N/A
Study type: Interventional

Some acute upper respiratory tract infection(AURI) in children is characterized by fever and vomiting,and it is one common reason for visiting a pediatrician. White blood count(WBC) usually increased in this children patients,hence antibiotics are often prescribed properly assumed. In the present study, it was hypothesized that it was not necessary to prescribe amoxicillin for the children.

NCT ID: NCT01915212 Completed - Healthy Volunteers Clinical Trials

Study of the Safety of a Particular Herpes Vaccine in Adults With or Without Herpes Infection

Start date: September 26, 2013
Phase: Phase 1
Study type: Interventional

Background: - Herpes simplex virus type 2 (HSV-2) is a major cause of genital herpes. It can also cause serious infection in newborns and in people with weakened immune systems. It increases the risk of getting an HIV infection and of spreading HIV to someone else. Therefore, a vaccine that could prevent genital herpes could improve the general health of the world s population. Researchers want to study whether a new vaccine, HSV529, which may be used in the future to prevent herpes infections, is safe. Objectives: - To test whether a new herpes vaccine is safe. Eligibility: - Healthy adults 18 40 years old. Design: - Participants will have 3 vaccination visits, 7 follow-up visits, and 3 follow-up phone calls over 1 year. - Each vaccination visit will last about 4 hours. - Participants will be screened with a medical history and physical exam. - Participants will have a blood sample taken. - Participants will be given the vaccine or a placebo, by injection from a needle. They will be monitored for 30 minutes to check for any allergic reaction. - Participants will be given a diary card to record any symptoms they may feel later. - At follow-up visits, participants will give a blood sample and answer health questions. - In the phone calls, participants will answer health questions.

NCT ID: NCT01910402 Completed - HIV Infections Clinical Trials

A Study to Determine Safety and Efficacy of Dolutegravir/Abacavir/Lamivudine (DTG/ABC/3TC) in Human Immunodeficiency Virus (HIV)-1 Infected Antiretroviral Therapy (ART) Naïve Women (ARIA)

Start date: August 22, 2013
Phase: Phase 3
Study type: Interventional

This study is designed to demonstrate the non-inferior antiviral activity of DTG/ABC/3TC fixed dose combination (FDC) once daily (OD) compared to atazanavir plus ritonavir (ATV+RTV) and tenofovir disoproxil fumarate/emtricitabine fixed dose combination (TDF/FTC FDC) OD in HIV-1 infected, ART-naïve women over 48 weeks. This study will also characterize the safety and tolerability of DTG/ABC/3TC FDC compared to ATV+RTV+TDF/FTC FDC. Sufficient number of subjects will be screened in order to ensure a total of approximately 474 subjects will be randomized (237 in each study arm)

NCT ID: NCT01906853 Active, not recruiting - Allergy Clinical Trials

Melbourne Infant Study - Bacille Calmette Guérin (BCG) for Allergy & Infection Reduction

MIS BAIR
Start date: July 2013
Phase: Phase 3
Study type: Interventional

1. To determine if BCG immunisation at birth, compared to no BCG immunisation, leads to a reduction in measures of allergy and infection in the first 12 months of life. 2. To evaluate the immunological mechanisms underlying the non-specific effects of BCG by comparing markers of immunity between the BCG and non-BCG groups.

NCT ID: NCT01904357 Completed - Infections Clinical Trials

Pediatric Cefazolin PK Study

Start date: March 2013
Phase: Phase 1
Study type: Interventional

The primary objective of this study is: • To examine the pharmacokinetics (PK) of cefazolin in children aged 10 to 12 years (inclusive) receiving weight-dependent 1gram (g) or 2g of cefazolin intravenous (IV) delivered over 30 minutes via the DUPLEX® drug delivery system for surgical prophylaxis. The secondary objectives of this study are: - To compare the PK data in children aged 10 to 12 years (inclusive)receiving 1g or 2g of cefazolin IV delivered over 30 minutes via the DUPLEX® drug delivery system with modeling data for adolescents aged 13-17 years (inclusive) and historical data from adults receiving a single 2g dose of cefazolin. - To assess the safety of a single dose of cefazolin in children aged 10 to 12 years (inclusive) receiving 1g or 2g of cefazolin IV delivered over 30 minutes via the DUPLEX® drug delivery system for surgical prophylaxis.

NCT ID: NCT01904188 Recruiting - Sepsis Clinical Trials

Clinical Microbial Species & Antibiotic Resistance ID in ED Patients Presenting With Infection - is Rapid ID Possible & Accurate?

Start date: June 2015
Phase:
Study type: Observational

The aim of this project is to test the utility of The Gene Z device (as of 2018 Gene Z no longer being used) and other rapid identification techniques that the investigators have developed in the lab on clinically obtained bodily fluid samples taken from patients with suspected infection or sepsis based on having three of four positive Systemic Inflammatory Response Syndrome markers, or having a known infection for which a specimen is being collected. Specimens will be collected by Sparrow Laboratories and McLaren Greater Lansing laboratories, processed and stored for analysis at a later date to determine if the microbial pathogens identified by current methods of culture, as well as pathogen susceptibility to antibiotics by culture results, can be identified by the GeneZ technology or other developed technology accurately, and more timely. It will not affect current patient care nor impact patient care, which will continue in the standard fashion today for sepsis. Results will be compared to standard culture results and antibiotic sensitivities.

NCT ID: NCT01887912 Terminated - Clinical trials for Clostridium Difficile Infection

Study of a Candidate Clostridium Difficile Toxoid Vaccine in Subjects at Risk for C. Difficile Infection

Start date: July 30, 2013
Phase: Phase 3
Study type: Interventional

The aim of this study was to evaluate the efficacy of the Clostridium difficile vaccine to prevent primary symptomatic C. difficile infection (CDI) in participants at risk for CDI where there is a substantial unmet medical need. Primary objective: - To assess the efficacy of the C. difficile vaccine in preventing the onset of symptomatic primary CDI confirmed by polymerase chain reaction (PCR) in adult participants aged >= 50 years who are at risk for CDI and have received at least 1 injection. Secondary Objectives: Efficacy: - To assess prevention of symptomatic PCR-confirmed primary CDI cases after 3 injections administered at 0, 7, and 30 days. - To assess prevention of symptomatic PCR-confirmed primary CDI cases after completion of at least 2 injections. Immunogenicity: - To describe the immunogenicity to toxin A and toxin B at specific time points in a subset of participant and in participants with CDI at Day 0 and Day 60. Safety: - To describe the safety profile of all participants who received at least 1 injection.