Ceftriaxone disodium salt hemi (heptahydrate) Clinical Trials

Size	Price	Qty
50mg	USD 147

Clinical Trials

Multiple clinical trials evaluate ceftriaxone across various therapeutic contexts, including bacterial infections, gonorrhea, drug resistance, antimicrobial stewardship, ascites in liver cirrhosis, antibiotic toxicity, and overdose. Primarily sponsored by academic institutions such as the Academisch Medisch Centrum, The University of Queensland, and University Hospital Montpellier, these studies encompass unassigned or non-applicable phase classifications. Their recruitment statuses range from recruiting and active not recruiting to completed and unknown.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05960006	Recruiting	Antibiotic Toxicity\|Liver Cirrhosis\|Renal Insufficiency\|Ceftriaxone Overdose\|Ascites Hepatic\|Infection Bacterial	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)\|Erasmus Medical Center	2023-07-10	--
NCT04268342	Active not recruiting	Drug Resistance Microbial\|Antimicrobial Stewardship\|Gonorrhea	The University of Queensland\|Kirby Institute\|Monash University\|South Australian Health and Medical Research Institute\|University of Melbourne\|University of California Los Angeles\|Griffith University\|Queensland Health\|St Vincent''s Hospital Sydney\|SpeeDx Pty Ltd\|NSW Health Pathology\|University of Sydney	2022-04-26	Not Applicable
NCT04902560	Completed	Gonorrhea	University Hospital Montpellier	2021-05-01	--
NCT05061875	Unknown status	Ceftriaxone Poisoning	Fundación Pública Andaluza para la gestión de la Investigación en Sevilla	2021-03-01	--

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the Ceftriaxone disodium salt hemi (heptahydrate) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ceftriaxone disodium salt hemi (heptahydrate) binds to and inhibits penicillin-binding proteins (PBPs), which blocks the cross-linking of peptidoglycan chains essential for bacterial cell wall synthesis and leads to cell lysis and bacterial death. This bactericidal mechanism accounts for its therapeutic efficacy in treating serious bacterial infections and gonorrhea, as well as guiding clinical investigations into its pharmacokinetic behavior in conditions such as liver cirrhosis with ascites.

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>).