Table 5.
Nanosystem-based antibiotics and anti-toxins in clinical trials different stages.
| Antibiotic | Clinical Trial | Medical Condition/Indication | Trial Phase | Intervention Treatment |
|---|---|---|---|---|
| Ciprofloxacin | Inhaled ciprofloxacin loaded-liposome: Once a day management of respiratory infections [54]. | P. aeruginosa | Phase 1 | Ciprofloxacin |
| Ciprofloxacin | Inhaled ciprofloxacin loaded-liposome: Once a day management of respiratory infections [54]. | P. aeruginosa | Phase 2a | Ciprofloxacin |
| Ciprofloxacin | Inhaled ciprofloxacin loaded-liposome in patients with non-cystic fibrosis bronchiectasis and chronic lung infection with Pseudomonas aeruginosa (ORBIT-3 and ORBIT-4): two phase 3, randomised controlled trials [208]. | Bronchiectasis and Chronic P. Aeruginosa Infection | Phase 3 | Inhaled Liposomal Ciprofloxacin |
| Ciprofloxacin | Phase 3 Study with Ciprofloxacin Dispersion for Inhalation in Non-Cystic Fibrosis Bronchiectasis (ORBIT-3) [209]. | Non-Cystic Fibrosis Bronchiectasis | Phase 3 | Ciprofloxacin dispersion for inhalation (Liquid mixture of liposomally encapsulated and un encapsulated ciprofloxacin) Placebo: Liquid formulation of empty liposomes. |
| Amikacin | Liposomal Amikacin for Inhalation (LAI) for Nontuberculous Mycobacteria [210]. | Mycobacterium Infections, Nontuberculous | Phase 2 | Liposomal amikacin for inhalation (LAI) Drug: placebo |
| Amikacin | Extension Study of Liposomal Amikacin for Inhalation in Cystic Fibrosis (CF) Patients with Chronic Pseudomonas Aeruginosa (Pa) Infection [213]. | Cystic Fibrosis Patients with Chronic Pseudomonas aeruginosa Infection | Phase 3 | Amikacin |
| Amikacin | Inhaled amikacin loaded-liposome for treating Mycobacterium Abscesses Lung Disease [212]. | Mycobacterium Infections, Nontuberculous Mycobacteria, Atypical |
Phase 2 | Liposomal amikacin for inhalation (LAI) plus multi-drug regimen |
| Amikacin | Study to Evaluate Efficacy of inhaled amikacin loaded-liposome combined with multi-drug regimen, Compared to Multi-drug Regimen Alone (CONVERT) [218]. | Mycobacterium Infections, Nontuberculous | Phase 3 | Liposomal Amikacin for Inhalation, 590 mg |
| Amikacin | Study of Dose Escalation of Liposomal Amikacin for Inhalation (ARIKAYCE™)-Extension Phase [211]. | Cystic Fibrosis | Phase 2 | Drug: Arikayce™ |
| Biological: CAL02 | CAL02; a liposomal adjunctive anti-toxin therapy in infections. A new therapeutic approach for severe community-acquired pneumonia [216]. | Severe community-acquired pneumonia | Phase 2 and 3 | CAL02 anti-toxin |
| Biological: GS-CDA1 Biological: MDX-1388 |
Study of the Clinical Effectiveness of a Human Monoclonal Antibody to C. Difficile Toxin A and Toxin B in Patients with Clostridium Difficile Associated Disease [219]. | Clostridium Difficile Associated Disease | Phase 2 | Biological: (GS-CDA1) Biological: MDX-1388 |