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The Regulatory Process and Gene Therapy 1
Published in Eric Wickstrom, Clinical Trials of Genetic Therapy with Antisense DNA and DNA Vectors, 2020
For plasmid gene therapies, one issue has been raised by the common use of ampicillin resistance as a selection marker. As stated in the "Points to Consider in the Characterization of Cell Lines Used to Produce Biologicals (1993)," penicillin and other beta-lactam antibiotics should be avoided in production cultures, due to the possibility of residual antibiotic or adducts in the final product and antibiotic hypersensitivity in some people. For licensed products, current regulations (21 CFR 6l0.6l(m)) require product labeling to declare any antibiotics added during manufacturing, and use of penicillin may concern physicians. If a construct has already been made and contains the amp" gene, it may be possible to use it in some situations if ampicillin is not used in making the final product. If the antibiotic is used in production, contact CBER concerning the nature of the protocol and the proposed patient population.
Chloramphenicol and Thiamphenicol
Published in M. Lindsay Grayson, Sara E. Cosgrove, Suzanne M. Crowe, M. Lindsay Grayson, William Hope, James S. McCarthy, John Mills, Johan W. Mouton, David L. Paterson, Kucers’ The Use of Antibiotics, 2017
Emergence of chloramphenicol-resistant S. typhi during treatment was first detected in Britain (Colquhoun and Weetch, 1950). Although such strains remained relatively rare for the next 20 years (Winshell et al., 1969), an epidemic of typhoid fever involving over 10,000 cases in Mexico occurred from February 1972 until June 1973. The S. typhi strain concerned possessed resistance to chloramphenicol, tetracycline, streptomycin, and the sulfonamides (Vazquez et al., 1972; Olarte and Galindo, 1973), mediated by a single plasmid (Balows, 1977). During this epidemic, a few S. typhi strains were isolated that were also resistant to ampicillin. Ampicillin resistance was mediated by a separate plasmid (Balows, 1977). Fortunately, strains with this dual resistance did not spread widely, and the vast majority of chloramphenicol-resistant organisms remained susceptible to ampicillin (Overturf et al., 1973; Datta and Olarte, 1974). After the epidemic in Mexico abated in 1973, typhoid remained endemic in the area, although the previously resistant S. typhi strains were replaced by chloramphenicol-susceptible ones (Balows, 1977).
Infections of the Central Nervous System
Published in John W. Scadding, Nicholas A. Losseff, Clinical Neurology, 2011
Cefotaxime or ceftriaxone are the antibiotics of choice; ampicillin resistance is common among H. influenzae and ampicillin should only be used once the organism is known to be sensitive. The duration of therapy should be for 10 days. In the resource-poor world, the mortality is nearly 30 per cent and another 30 per cent have major sequelae.
Research progress of nanocarriers for gene therapy targeting abnormal glucose and lipid metabolism in tumors
Published in Drug Delivery, 2021
Xianhu Zeng, Zhipeng Li, Chunrong Zhu, Lisa Xu, Yong Sun, Shangcong Han
The recombinant adenovirus was constructed by cloning the 2,337 base-pair PCR product into linearized adenovirus plasmid GV314 using T4 DNA ligase and transfecting into competent Escherichia coli cells. Positive clones were screened by ampicillin resistance and then underwent ABI 3730 sequencing analysis. SIK1-overexpressing adenovirus (Ad-SIK1) was packaged in human embryonic kidney 293 T cells and purified with the Adenovirus X purification kit. The virus titer was determined by an end-point dilution method (Zhou et al. 2019). The results showed that SIK1 plays an important role in the regulation of liver glucose and lipid metabolism, and it inhibits liver gluconeogenesis and lipogenesis. SIK1 also plays a role in the regulation of metabolic diseases and is found in tumor diseases. In cervical squamous cell carcinoma cells, SIK1 inhibits the invasion and metastasis of cancer cells (Peng et al. 2020). In colorectal cancer, the upregulated targeting of SIK1 by miR-17 has been found to promote the process of colorectal cancer, and thus, this mechanism has also become a potential therapeutic target (Huang et al. 2019).
Severe, non specific symptoms in non-typhoidal Salmonella infections in adult patients with sickle cell disease: a retrospective multicentre study
Published in Infectious Diseases, 2018
Romain Guery, Anoosha Habibi, Jean-Benoît Arlet, François Lionnet, Victoire de Lastours, Jean-Winoc Decousser, Jean-Luc Mainardi, Keyvan Razazi, Laurence Baranes, Pablo Bartolucci, Bertrand Godeau, Fréderic Galacteros, Marc Michel, Matthieu Mahevas
NTS episodes were community-acquired in all cases. Isolated serotypes were: ser. Enteritidis (n = 8), ser. Typhimurium (n = 6), ser. Dublin (n = 2), ser. Wichita (n = 1). Definitive serovars were undetermined for six isolates. All cultures were monomicrobial. Blood cultures were positive in 65% of episodes. Salmonella spp. was also found in synovial fluid or bone biopsy (n = 6), abscess fluid (n = 5), stool culture (n = 1), adenitis (n = 1). Highest antibiotic resistance was observed with ampicillin (30%), followed by sulfamethoxazole-trimethoprim (9%) and nalidixic acid (9%). As expected, Penicillin V prophylaxis was associated with ampicillin resistance of Salmonella spp. isolates (4 isolates were ampicillin resistant among 5 cases under penicillin prophylaxis). No resistance was observed for third-generation cephalosporins or aminoglycosides. Supplementary Table I outlines the characteristics of antimicrobial therapy during NTS episodes. Third-generation cephalosporins were more commonly used as first-line agents, followed by fluoroquinolones or sulfamethoxazole-trimethoprim. High prevalence of osteo-articular localizations (n = 13) and secondary foci (n = 9) explained prolonged treatment duration (median 44 days [range 7–102]).
Parabacteroides distasonis: intriguing aerotolerant gut anaerobe with emerging antimicrobial resistance and pathogenic and probiotic roles in human health
Published in Gut Microbes, 2021
Jessica C. Ezeji, Daven K. Sarikonda, Austin Hopperton, Hailey L. Erkkila, Daniel E. Cohen, Sandra P. Martinez, Fabio Cominelli, Tomomi Kuwahara, Armand E. K. Dichosa, Caryn E. Good, Michael R. Jacobs, Mikhail Khoretonenko, Alida Veloo, Alexander Rodriguez-Palacios
In a study by Sóki et al. conducted in 2020,83 the resistance of intestinal isolates of different bacterial species, including P. distasonis, was evaluated against several antimicrobials. The relevant MIC values were compared between clinical and intestinal isolates. Several notable observations can be made from their findings, summarized in Table 1. For example, in the clinical and intestinal isolates of all species examined, ampicillin resistance is almost 100%; moxifloxacin, cefoxitin, and clindamycin resistance is intermediate (13–44%); and amoxicillin/clavulanate, imipenem, metronidazole, and tigecycline resistance is very low (0–4%).83