Track topics on Twitter Track topics that are important to you
The primary objective of the study is to determine the estimated clinical specificity of the AAD Plus. A secondary objective is to determine the estimated sensitivity of the AAD Plus as 10% of the study subject samples will be contrived to be positive.
This study is a multi-site trial assessing the clinical specificity of AAD Plus using capillary blood, venous blood, and venous serum samples collected from presumptive anthrax negative subjects who present with symptoms consistent with cold, flu or other bronchial and febrile infections in the US. At least 440 subjects who meet the study eligibility criteria will have 3 blood samples from a single time point tested with the AAD Plus device. The samples will be: 1) capillary blood collected by finger stick; 2) venous blood collected in a sodium citrate anticoagulant tube; and, 3) serum obtained from venous blood collected in a serum separator tube. The capillary blood sample will be tested immediately to avoid clotting by an unblinded staff member. The venous blood and serum samples will be tested by a blinded staff member as soon as possible after preparation. Additional aliquots of the serum sample will be prepared and stored frozen at -20 ± 2°C or colder for possible additional reference testing [CDC reverse-transcriptase polymerase chain reaction (RT-PCR) assay (K140426)] in the event that any of the subject's capillary blood, venous blood, or serum sample is positive.
At each clinical site, subjects' paired venous whole blood and serum samples will be randomly selected such that 10% of all subjects' samples (total of 40) will be spiked with recombinant anthrax lethal factor (LF) to prepare a contrived positive sample. Each clinical site will be provided a unique randomization list by the Data Management Center that identifies, which subjects will be randomized for spiking with LF. The numbers of spiked samples will be distributed approximately equally between all sites. An unblinded site staff member will prepare the blinded, spiked (from 40 subjects selected for spiking) and unspiked (from 400 subjects that are not selected for spiking) venous blood and serum specimens to be tested by a blinded staff member. Before the venous blood sample and serum specimens (from subjects selected for spiking) are spiked; the unblinded staff member will also test all unspiked samples on the AAD Plus and record the results. Then the spiked venous blood and serum sample will be given to the blinded staff member for testing. Thus, blinded staff will receive whole blood and serum samples that could be either unspiked (presumed negative) or spiked (presumed positive) to preserve the blind. In the rare event that the AAD Plus test result is positive on the unspiked sample tested by the unblinded staff member, then the unblinded staff member will give the unspiked sample from this subject to the blinded operator for AAD Plus testing and the subject's serum sample will be sent for reference testing as described above. Blinded staff will remain blinded throughout the study to the contrived spiking of the whole blood and serum samples as to which samples were contrived.
Active Anthrax Detect™ Plus (AAD Plus)
Fiel Family and Sports Medicine/CCT Research
Not yet recruiting
InBios International, Inc.
Published on BioPortfolio: 2020-03-29T04:04:52-0400
This study will evaluate safety and clinical benefit of AIGIV used for treatment of patients with inhalational anthrax. This study will be implemented only in the event of a major anthrax ...
This is a dose ranging study comparing different vaccine schedules of rPA vaccine, for Anthrax, to the licensed dose of AVA, another Anthrax vaccine. Safety and the capability to induce an...
This study will evaluate safety and clinical benefit of AIGIV used for treatment of patients with systemic anthrax. The study is designed to collect information on safety, clinical benefit...
This study is designed to evaluate the lot consistency (using three consecutively manufactured lots), safety, and ability of the AV7909 anthrax vaccine to generate an immune response in he...
The trial investigates Px563L and RPA563, two formulations of a novel anthrax vaccine.
A 2016 outbreak of anthrax on the Yamal Peninsula in Siberia that led to the culling of more than two hundred thousand reindeer and killed one human, resulted in significant media interests and in the...
Cutaneous anthrax (CA), a zoonotic infectious disease is an important endemic public health disease in rural areas around the world, accounting for 95% of anthrax cases.
Anthrax is endemic in Georgia and recent outbreaks prompted a livestock-handler case-control study with a component to evaluate anthrax knowledge, attitudes, and practices (KAP) among livestock handle...
Human anthrax cases necessitate rapid response. We completed Bacillus anthracis nanopore whole-genome sequencing in our high-containment laboratory from a human anthrax isolate hours after receipt. Th...
Bacillus anthracis, the causative agent of anthrax, is a harmful pathogen with potential ability as a biological weapon which persuades scientists to develop novel methods to detect anthrax from infec...
An acute infection caused by the spore-forming bacteria BACILLUS ANTHRACIS. It commonly affects hoofed animals such as sheep and goats. Infection in humans often involves the skin (cutaneous anthrax), the lungs (inhalation anthrax), or the gastrointestinal tract. Anthrax is not contagious and can be treated with antibiotics.
ANTHRAX outbreak that occurred in 1979 and was associated with a research facility in Sverdlovsk, in the Ural mountain region of central RUSSIA. Most victims worked or lived in a narrow zone extending from the facility. The zone of anthrax-caused livestock mortality paralleled the northerly wind that prevailed shortly before the outbreak. It was concluded that an escape of ANTHRAX caused outbreak.
Vaccines or candidate vaccines used to prevent ANTHRAX.
A species of bacteria that causes ANTHRAX in humans and animals.
The ability to detect sharp boundaries (stimuli) and to detect slight changes in luminance at regions without distinct contours. Psychophysical measurements of this visual function are used to evaluate visual acuity and to detect eye disease.
Antiretroviral Therapy Clostridium Difficile Ebola HIV & AIDS Infectious Diseases Influenza Malaria Measles Sepsis Swine Flu Tropical Medicine Tuberculosis Infectious diseases are caused by pathogenic...
Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...
Polymerase Chain Reaction (PCR)
PCR (Polymerase Chain Reaction) uses the ability of DNA polymerase (enzymes that create DNA molecules by assembling nucleotides, the building blocks of DNA. These enzymes are essential to DNA replication and usually work in pairs to create two ident...