Ticarcillin sodium Clinical Trials

Size	Price	Qty
50mg	USD 147

Clinical Trials

A clinical trial sponsored by investigator Phillip Brian Smith at Duke University aimed to assess the pharmacokinetic profile and safety of a ticarcillin-clavulanate combination for treating sepsis in infant patients. However, this Phase I study was withdrawn prior to completion without initiating active patient enrollment, leaving clinical data for ticarcillin in this pediatric population limited.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01229046	Withdrawn	Sepsis	Phillip Brian Smith\|Duke University	2010-09	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ticarcillin acts by binding to bacterial penicillin-binding proteins (PBPs), thereby inhibiting the transpeptidation step of cell wall peptidoglycan synthesis. This inhibition weakens bacterial structural integrity and induces cell lysis, delivering broad-spectrum bactericidal efficacy essential for combatting bacterial pathogens implicated in systemic conditions such as sepsis.

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>).