title: Looking for the new preparations for antibacterial therapy. II. Clinical trials; new beta-lactam antibiotics and beta-lactamase inhibitors.
abstract: To obtain a status of a medicinal product, a compound possessing potential antimicrobial activity and displaying no cytotoxicity, must undergo three phases of clinical trials to prove its therapeutic efficacy, safety and quality. Properties of the compound should be based on the results of studies meeting specific criteria. Studies should be: randomized, double-blind, involving sufficient number of volunteers, concerning the infections localized in strictly defined area and caused by identified microorganisms. After the medicinal product is authorized to be on the market, clinical trials of the fourth phase are carried out to detect adverse effects, overdose symptoms, interactions of the new drug with other medicinal products and to establish characteristic of activity among groups such as children, elderly, women in pregnancy and patients suffering from other diseases, but only if the benefits of receiving treatment outweigh the risks. This article is a second part of the series associated with searching for new antibacterial agents and it relates to performance of clinical trials and the new compounds belonging to the class of beta-lactams. Among the 9 presented compounds, candidates to become medicinal products, two belong to the cephalosporins (CXA-101, S-649266), one to carbapenems (razupenem), three to monobactams (BAL30072, BAL30376, MC-1) and three to beta-lactamase inhibitors (NXL-104, MK-7655, ME1071).
authors.affiliation: Department of Antibiotics and Microbiology, National Medicines Institute, Warsaw, Poland.
authors.forename: Izabela
authors.initials: I
authors.lastname: Karpiuk
authors.forename: Stefan
authors.initials: S
authors.lastname: Tyski
mesh_terms: D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D015780:Carbapenems / Q000627:therapeutic use; D002511:Cephalosporins / Q000627:therapeutic use; D024881:Drug Resistance, Bacterial / Q000187:drug effects*; D015507:Drugs, Investigational / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008997:Monobactams / Q000627:therapeutic use; D011247:Pregnancy; D065093:beta-Lactamase Inhibitors
chemical_list: D000900:Anti-Bacterial Agents; D015780:Carbapenems; D002511:Cephalosporins; D015507:Drugs, Investigational; D008997:Monobactams; D065093:beta-Lactamase Inhibitors