Multiple clinical trials evaluate amikacin across therapeutic contexts including multidrug-resistant tuberculosis, febrile neutropenia, asymptomatic colonization, and nosocomial infections complicating COVID-19. Encompassing Phase 2, Phase 4, and non-phased evaluations, these studies—currently recruiting, completed, or active, not recruiting—are sponsored by university hospitals, medical centers, and global health organizations such as the World Health Organization. Key investigations focus on dosing optimization and target attainment to improve therapeutic outcomes in drug-resistant bacterial infections.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT05555303 | Recruiting | Tuberculosis Multidrug-Resistant |
Rwanda Biomedical Centre|Institute of Tropical Medicine|World Health Organization |
2023-03-01 | Phase 2 |
| NCT05689450 | Completed | Febrile Neutropenia (FN) |
University Hospital Basel Switzerland |
2022-12-21 | -- |
| NCT05593601 | Recruiting | Colonization Asymptomatic |
Mahidol University |
2022-11-24 | Phase 4 |
| NCT05511129 | Active not recruiting | COVID-19|Nosocomial Infection |
Fondation Hôpital Saint-Joseph |
2022-05-12 | -- |
| NCT04239326 | Completed | Tuberculosis Multidrug-Resistant |
Foundation for Innovative New Diagnostics Switzerland |
2021-04-16 | -- |
(data from https://clinicaltrials.gov, updated on 2024-05-22)
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).