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NCT ID: NCT03299283 Enrolling by invitation - Clinical trials for Respiratory Tract Infections

Specimen Collection and Transport Workflow Evaluations for CLIA-waived Molecular Testing

Start date: October 5, 2017
Phase:
Study type: Observational

The purpose of this study is two-fold. In the first phase, the goal is to characterize the stability of respiratory (nasal swab, nasopharyngeal swab, and throat swab; NS, NPS, TS) and stool (raw stool and rectal swab) specimens collected using various standard, medically established procedures with and without transport media and tested at various time points and under different temperature conditions, and also to look at variation between repeat sampling events. The intention is for these data to support decisions made by BioFire regarding the appropriate specimen type and handling guidelines for future tests. In the second phase of the study, collection and transport conditions identified in Phase 1 will be used to collect specimens for pilot performance evaluations of a new molecular diagnostic test.

NCT ID: NCT03228095 Enrolling by invitation - Colorectal Cancer Clinical Trials

Volatiles in Breath and Headspace Analysis - Diagnostic Markers

Volatolome
Start date: July 24, 2017
Phase:
Study type: Observational

Detection of Volatile Organic Compounds (VOC) directly from tissue by headspace analysis (skin, surgery material, other tissue) and exhaled breath is feasible using affordable user-friendly novel nano-chemo sensors that can accurately be used for screening and monitoring purpose

NCT ID: NCT03200470 Enrolling by invitation - Clinical trials for Prosthetic Joint Infection

The Utility of Next-generation Sequencing for the Diagnosis of Periprosthetic Joint Infection

Start date: February 16, 2017
Phase: N/A
Study type: Observational

This is a prospective multicenter study. All patients presenting for revision hip or knee arthroplasty for all indications under the respective surgeon's care may be eligible. Per standard of care preoperatively, all patients must have blood drawn for erythrocyte sedimentation rate(ESR), C-reactive protein(CRP) and D-dimer. Aspiration of the joint in question may be performed at the discretion of the treating surgeon and results documented. Intraoperative samples will also be collected and sent for NGS analysis

NCT ID: NCT03064100 Enrolling by invitation - Systemic Infection Clinical Trials

Pilot Evaluation of the FilmArray® Childhood Systemic Infection (CSI) Panel

Start date: March 21, 2017
Phase: N/A
Study type: Observational

The purpose of this study is to collect data to support decisions made by BioFire regarding assay development, panel composition, and intended use for the final FilmArray CSI reagent pouch. The study will utilize whole blood and/or plasma obtained from pediatric patients under 18 years of age that present with acute fever.

NCT ID: NCT02510053 Enrolling by invitation - Clinical trials for Invasive Fungal Infection

Pharmacokinetics and Pharmacodynamics of Caspofungin (Cancidas ®) and Drug Tolerance of Fungi to Patients With an Invasive Fungal Infection in the Intensive Care Unit

Start date: July 2014
Phase: N/A
Study type: Interventional

To investigate pharmacokinetics(PK) and pharmacodynamics(PD) of Caspofungin in ICU patients after received a loading dose of 70mg followed by 50mg (35mg if Child-Pugh score is 7-9), 40 patients will be recruited. Blood samplings for PK analysis will be collected on day 4 in this study. Caspofungin plasma concentrations are measured by using solid phase extraction and reverse phase high-performance liquid chromatography. Safety analyses will be taken daily during the treatment of Caspofungin. Tests for drug tolerance of fungi and efficacy assessment (clinical and mycological responses) will be taken every 3 days by clinical and mycological tests.

NCT ID: NCT02338986 Enrolling by invitation - Infection Clinical Trials

Collection of Plasma From People Who Recovered From or Were Vaccinated to Emerging Infectious Diseases

Start date: March 4, 2015
Phase:
Study type: Observational

Background: - There are more emerging infectious diseases recently. Some could affect many people. Some like Severe Acute Respiratory Syndrome (SARS) or Middle East Respiratory Syndrome (MERS) are caused by new germs. Sometimes known germs suddenly infect new and large areas, like Ebola. Many of these diseases don t have good treatments available. Researchers may be able to develop a treatment by using antibodies against these infections. Objective: - To collect antibodies from people with high levels of antibodies to the diseases being studied. Eligibility: - Ages 18-70 years old who weigh at least 110 pounds. They may have been infected with or vaccinated for one of the new infections researchers are studying. Design: - Participants will be screened with medical history and blood tests. Researchers will determine if the participant can have apheresis. - Participants will have apheresis. First, they will be interviewed. Then, a needle will be placed in a vein. Blood will be drawn, and a machine will separate the blood cells from the antibodies and protein. The blood cells will then be returned to the participant through another vein. It takes about 60 minutes for the actual collection. - Participants will be asked to have the procedure at least 3 times. They can participate in up to 20 sessions total as part of this study. There must be at least 7 days between sessions.

NCT ID: NCT02271737 Enrolling by invitation - Neonatal Infection Clinical Trials

Newborn Infection Control and Care Initiative for Health Facilities to Accelerate Reduction of Newborn Mortality

NICCI
Start date: February 2015
Phase: N/A
Study type: Interventional

Newborn mortality continues to be unacceptably high in Cambodia, despite reductions in maternal and under five year old mortality. Evidence exists that a large proportion of newborn mortality globally and in Cambodia is attributable to infections and sepsis. The study proposes a package intervention to address infection control in the perinatal period in facilities and to improve the timeliness of referral of newborns with suspected infections to appropriate health facilities for treatment through upgrading of hygiene practices in facilities and linking of community based volunteers with health facilities and families in the community setting. By delivering a coordinated intervention that combines improved education for health center midwives, village health care workers, and mothers of newborns, along with improved care coordination with increase in number of interactions (points of contact) between mothers and health care personnel, the investigators will see improved knowledge of newborn danger signs among mothers and health care workers, more rapid case detection of significant newborn illnesses, and more rapid and appropriate referral of ill newborns. The investigators also hypothesize that the common causes of newborn sepsis in Cambodia are different from those reported in Western cultures, and that Staphylococcus aureus will be a common pathogen as described in neighboring Laos. The investigators will evaluate the causes of newborn sepsis in the subset of infants referred to Takeo Provincial Hospital.

NCT ID: NCT02104791 Enrolling by invitation - Clinical trials for Intra-amniotic Subclinical Infection.

Evaluation of the Role of Plasma Procalcitonin in Prediction of Intra-amniotic Infection in Preterm Premature Rupture of Membrane

Start date: May 2014
Phase: N/A
Study type: Observational

It is hypothesized that the procalcitonin has a role to play in prediction of intra-amniotic subclinical infection.

NCT ID: NCT01897831 Enrolling by invitation - Clinical trials for Urinary Tract Infections

Piperacillin Sodium and Sulbactam Sodium for Injection (2:1) for Treatment of Respiratory and Urinary Tract Infection

PIP-SBT
Start date: August 2011
Phase: Phase 4
Study type: Interventional

In the proposed study, the investigators plan to evaluate the efficacy and safety of Piperacillin sodium and sulbactam sodium for injection (2:1) for the treatment of respiratory and urinary tract acute bacterial infection under the widely used in clinical conditions.

NCT ID: NCT01646411 Enrolling by invitation - Clinical trials for Acute Viral Infections

300 Antibody Diagnostic Test Kit

Antibody 300
Start date: August 2012
Phase: N/A
Study type: Observational

For the development of a Point of Care IVD test kit for acute phase disease detection against a variety of bacterial and viral infections. Phase one includes 100 clinical diagnosed positive and 200 clinically "normal" serum and whole blood matched specimens for specificity and sensitivity determination for each marker. The positive samples must be IgM positive using any FDA cleared ELISA test kit. The negatives samples must be negative for IgM.