Clinical Trials
Multiple clinical trials have evaluated Clindamycin HCl across indications including moderate acne vulgaris, critical care bacterial infections, and staphylococcal prosthetic joint infections. Sponsored by academic medical centers such as Jinnah Postgraduate Medical Centre, Alexandria University, and University Hospital Brest, these studies include Phase 2 and unspecified phase evaluations with recruitment statuses ranging from completed to unknown. Together, these trials underscore clinical interest in refining clindamycin administration for both dermatological and systemic microbial infections.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT05926869 | Completed | Acne Vulgaris |
Jinnah Postgraduate Medical Centre |
2022-08-01 | Phase 2 |
| NCT05223400 | Completed | Infection Bacterial |
Alexandria University |
2022-03-01 | -- |
| NCT04946500 | Unknown status | Prosthetic Joint Infection|Staphylococcus |
University Hospital Brest |
2021-05-15 | -- |
(data from https://clinicaltrials.gov, updated on 2024-05-22)
Compliance for Clinical Use
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>).