Ampicillin Trihydrate Clinical Trials

Size	Price	Qty
50mg	USD 97

Clinical Trials

Multiple clinical trials evaluate the therapeutic and pharmacokinetic profiles of ampicillin trihydrate across Phase 1, Phase 4, and unassigned trial phases. These studies investigate conditions including infective endocarditis, neonatal therapeutic hypothermia, DYT-1 dystonia, and ventilator-associated pneumonia. Sponsored by academic and healthcare institutions—such as Uppsala University, Drexel University, the University of Florida in collaboration with Tyler's Hope for a Dystonia Cure Inc., and Hospital Pablo Tobón Uribe—the trials encompass actively recruiting, completed, and withdrawn recruitment statuses.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04647331	Recruiting	Infective Endocarditis	Uppsala University	2021-06-01	--
NCT03129620	Completed	Hypothermia	Drexel University	2013-03	--
NCT01433757	Completed	DYT-1\|Dystonia	University of Florida\|Tyler''s Hope for a Dystonia Cure Inc	2011-09	Phase 1
NCT01118403	Withdrawn	Ventilator Associated Pneumonia	Hospital Pablo Tobón Uribe	2011-03	Phase 4

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ampicillin Trihydrate is a beta-lactam antibiotic that selectively binds to and inactivates transpeptidases on the inner bacterial cell membrane, thereby inhibiting peptidoglycan cross-linking required for cell wall synthesis. This inhibition compromises structural cell wall integrity and leads to osmotic lysis of sensitive bacteria, conferring clinical utility against bacterial pathogens involved in conditions such as infective endocarditis and ventilator-associated pneumonia.

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>).