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Antibiotic resistance is a form of drug resistance where bacteria are able to survive after exposure to one or more antibiotics. Bacteria that are resistant to multiple antibiotics are considered multidrug resistant (MDR) or, more colloquially, superbugs.
Commons types of drug resistance bacteria include MRSA methicillin-resistant Staphylococcus aureus, VRSA (vancomycin-resistant S. aureus), ESBL (extended spectrum beta-lactamase), VRE (vancomycin-resistant Enterococcus) and MRAB (multidrug-resistant A. baumannii). While mostly hospital acquired some are being transmitted in the community. In the simplest cases, drug-resistant organisms may have acquired resistance to first-line antibiotics, thereby necessitating the use of second-line agents. Typically, a first-line agent is selected on the basis of several factors including safety, availability, and cost; a second-line agent is usually broader in spectrum, has a less favourable risk-benefit profile, and is more expensive or, in dire circumstances, may be locally unavailable. In the case of some MDR pathogens, resistance to second- and even third-line antibiotics is, thus, sequentially acquired, a case quintessentially illustrated by Staphylococcus aureus in some health care settings. Some pathogens, such as Pseudomonas aeruginosa, also possess a high level of resistance.
It may take the form of a spontaneous or induced genetic mutation, or the acquisition of resistance genes from other bacterial species by horizontal gene transfer via conjugation, transduction, or transformation. Many antibiotic resistance genes reside on transmissible plasmids, facilitating their transfer. Exposure to an antibiotic naturally selects for the survival of the organisms with the genes for resistance. In this way, a gene for antibiotic resistance may readily spread through an ecosystem of bacteria. Once a bacterium becomes resistant to an antibiotic, it is unable to return to its previous state of vulnerability. Resistance will be passed on to all of the daughter cells of the resistant microbe. Antibiotic-resistance plasmids frequently contain genes conferring resistance to several different antibiotics. This is not the case for Mycobacterium tuberculosis, the bacteria that causes tuberculosis, since evidence is lacking for whether these bacteria have plasmids. Also M. tuberculosis lack the opportunity to interact with other bacteria in order to share plasmids.
Genes for resistance to antibiotics, like the antibiotics themselves, are ancient. However, the increasing rates of antibiotic-resistant bacterial infections seen in clinical practice stems from antibiotic use both within human medicine and veterinary medicine. Any use of antibiotics can increase selective pressure in a population of bacteria to allow the resistant bacteria to thrive and the susceptible bacteria to die off. As resistance towards antibiotics becomes more common, a greater need for alternative treatments arises. However, despite a push for new antibiotic therapies, there has been a continued decline in the number of newly approved drugs. Antibiotic resistance therefore poses a significant problem. Antibiotic resistance is a serious and growing problem. A World Health Organization report released April, 2014 states, "this serious threat is no longer a prediction for the future, it is happening right now in every region of the world and has the potential to affect anyone, of any age, in any country. Antibiotic resistance–when bacteria change so antibiotics no longer work in people who need them to treat infections–is now a major threat to public health."
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Importance and scope:
In general, clinical studies are designed to add to medical knowledge related to the treatment, diagnosis, and prevention of diseases or conditions. Some common reasons for conducting clinical studies include: Evaluating one or more interventions (for example, drugs, medical devices, approaches to surgery or radiation therapy) for treating a disease, syndrome, or condition Finding ways to prevent the initial development or recurrence of a disease or condition. These can include medicines, vaccines, or lifestyle changes, among other approaches.Evaluating one or more interventions aimed at identifying or diagnosing a particular disease or condition,Examining methods for identifying a condition or the risk factors for that condition.
New technologies and the outsourcing of antibiotics to lower-cost countries will slow the recent annual increases in expenditures in the U.S. to a 3.3% compound annual growth rate (CAGR) over the forecast period. Clinical trial spending in 2010 is an estimated $25 billion and is expected to reach $28.5 billion by 2014. The report provides an overview of clinical development phases, the regulatory issues involved, and the factors influencing clinical trial costs. An overview is provided of new technologies that will be affecting the clinical trial process in the near future.
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