Clinical Trials

Chloramphenicol is currently evaluated across several clinical trials spanning Early Phase 1, Phase 3, and Phase 4 stages in ophthalmology, pediatric dentistry, and pulmonology. Sponsored by academic institutions including Sohag University, the University of Sao Paulo, and Makerere University, these studies explore lacrimal system ophthalmopathy, pediatric severe pneumonia, and dental pulp diseases requiring pulpectomy in primary teeth. Study statuses range from completed evaluations of topical ocular combination therapies and pediatric pneumonia interventions to upcoming trials assessing emergency endodontic pastes.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07542639 NOT_YET_RECRUITING
Pulp Disease, Dental; Pulp Necrosis; Pulp Therapy in Primary Molars; Primary Teeth; Pulpectomy; Endodontics; Dental Care for Children; Treatment Outcome; Quality of Life; Health Services Accessibility
University of Sao Paulo
 2026-06-08 EARLY_PHASE1
NCT05028907 COMPLETED
Ophthalmopathy , Lacrimal System
Sohag University
 2020-11-15 PHASE4
NCT00372541 COMPLETED
Pneumonia
Makerere University
 2006-09 PHASE3

(data from https://clinicaltrials.gov, updated on 2026-05-12)

Check the Chloramphenicol product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Chloramphenicol selectively binds to the A2451 and A2452 residues within the 23S rRNA of the bacterial 50S ribosomal subunit, thereby inhibiting peptidyl transferase activity and preventing peptide bond elongation during bacterial protein synthesis. This inhibition exerts a bacteriostatic effect that halts bacterial growth, facilitating the resolution of microbial pathogens implicated in clinical conditions such as pediatric pneumonia, dental pulp necrosis, and lacrimal system disorders.

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>).

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Note: Technical data last updated: Sep 1, 2026.