Table 1. Main characteristics of the described antibacterial drugs15,16,23,30,31,34,43,47,53.
Food and Drug Administration (FDA), European Medicines Agency (EMA), complicated intra-abdominal infections (cIAIs), complicated urinary tract infections (cUTIs), hospital acquired bacterial pneumonia (HABP), ventilator associated bacterial pneumonia (VABP), acute bacterial skin and skin structure infections (ABSSI), intravenous (iv), hours (h), therapy (ther.).
| NAME (generic/brand/ class) | Approval status | Indication | Administration | Dose and duration |
|---|---|---|---|---|
| Ceftazidime/avibactam / avycaz (USA), zavicefta (Europe) / combination of ceftazidime, 3rd generation cephalosporin, with avibactam, a β-lactamase inhibitor COMPANY: Allergan Inc (USA), Pfizer (Europe) | FDA: 1. since 2015 in combination with metronidazole (cIAIs cUTIs 2. since 01/02/2018 for HABP and VABP EMA: 1. since 2016 for cIAIs, cUTIs, HABP, VABP 2. infections due to aerobic Gram-negative organisms (adults - limited options) | CIAIs, cUTIs, HABP, VABP | Ceftazidime 2g and avibactam 0.5g. IV infusion over 2h | 1. For cIAIs and cUTIs, ceftazidime 2g / avibactam 0.5g every 8 hours, for 5-14 days. 2. For HABP and VABP, ceftazidime 2g / avibactam 0.5g /8h for 7-14 days. 3. Adaptation of doses in case of renal function impairment. |
| Obiltoxaximab/ Anthim/ Monoclonal antibody COMPANY : Elusys Therapeutics | FDA: approved in March 2016 EMA: not approved | Inhalational anthrax | Diluted in 0.9% Sodium Chloride,IV infusion over 1 hour and 30 minutes | Adult patients 16 mg/kg. In paediatric patients, weight adaptation needed, greater than 40 kg - 16 mg/kg, 15 to 40 kg - 24 mg/kg, less than or equal to 15 kg - 32 mg/kg |
| Bezlotoxumab/ Zinplava/ Monoclonal antibody COMPANY: Merck Sharp & Dohme Limited | FDA: Approved in October 2016 EMA: Approved in January 2017 | Prevention of CDI recurrence, in >18 years old patients with antibiotic ther. | Diluted solution iv infusion over 60 min using a low-protein binding 0.2-5 µm in-line or add-on filter. | Recommended dosage is 10 mg/kg. Not evaluated in patients below 18 years of age |
| Delafloxacin/ Baxdela/ fluoroquinolones COMPANY: Melinta Therapeutics | FDA: approved in June 2017 for ABSSI EMA: application in March 2018 | ABSSI | IV infusion or oral use | 300 mg/12h for 5-14 days iv infusion over 1h 450 mg/12h orally for 5 to 14 days. Renal adaptation needed. |
| Meropenem-Vaborbactam/ Vabomere/ combination of meropenem, and vaborbactam, a β-lactamase inhibitor COMPANY: Melinta Therapeutics | FDA: approved in August 2017 for adults with cUTI, including pyelonephritis EMA: marketing authorization application submitted in July 2017 | cUTI, including pyelonephritis | Single-dose vials containing 2 g (1 g meropenem and 1 g vaborbactam) as a sterile, dry powder (iv) | 4g administered over 3 hours by intravenous infusion every 8 hours for up to 14 days. Renal adaptation needed. |
| Ozenoxacin/ xepi/ non-fluorinated quinolone COMPANY: Medimetrics Pharm. | FDA: approved in Dec. 2017 for the treatment of impetigo Staph. Aureus, Strept. pyogenes (> 2 months old) | Impetigo | Pale-yellow 1% cream, Topical use only | Topically applications to the affected area twice a day for 5 days |