Clinical Trials

Multiple clinical trials ranging from Phase II to Phase IV evaluate the efficacy and safety of pivmecillinam across various recruitment statuses, including completed, actively recruiting, terminated, and not yet recruiting. Sponsored by academic medical centers, hospital trusts, and pharmaceutical entities such as Uppsala University, Rigshospitalet, and Benova Innovative Medicine Research, these studies primarily focus on bacterial urinary tract infections, including uncomplicated cystitis, pyelonephritis, and febrile urosepsis. Additionally, research addresses post-cystectomy infection prophylaxis, genital tract infections, and infections among kidney transplant recipients.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07407673 NOT_YET_RECRUITING
Kidney Transplant Infection; Bloodstream Infection; Kidney Transplant; Kidney Transplant Recipients; Infection; Urinary Tract Infection(UTI); Urinary Tract Infection Bacterial; Antibiotic Prophylaxis; Bacteriuria
Susanne Dam Nielsen, MD, DMSc
 2027-01-01 PHASE3
NCT07236944 RECRUITING
Febrile Urinary Tract Infection
Uppsala University
 2025-12 PHASE4
NCT05224401 RECRUITING
Urinary Tract Infections; Bacteremia; Antibiotic Resistant Infection
Lund University
 2023-05-29 PHASE3
NCT06709196 RECRUITING
Cystectomy; Bladder Cancer Requiring Cystectomy; Postoperative Infections; Antibiotic Prophylaxis; Ileal Conduit
Rigshospitalet, Denmark
 2025-01-07 PHASE4
NCT04959331 COMPLETED
Urinary Tract Infections
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
 2021-11-02 PHASE4
NCT05545137 COMPLETED
Uncomplicated Urinary Tract Infection
Benova (Tianjin) Innovative medicine Research Co., Ltd.
 2022-09-29 PHASE3
NCT03228108 COMPLETED
Complication; Infection; Prostate Cancer
Radboud University Medical Center
 2018-04-03 PHASE4
NCT03282006 COMPLETED
Pyelonephritis; Urinary Tract Infections
Sykehuset i Vestfold HF
 2017-09-29 PHASE4
NCT02083276 TERMINATED
Chlamydia Trachomatis Infection; Chlamydial Urethritis
Oslo University Hospital
 2014-03 PHASE2

(data from https://clinicaltrials.gov, updated on 2026-07-22)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

As an oral prodrug of mecillinam, pivmecillinam selectively binds to bacterial penicillin-binding protein 2 (PBP-2) in Gram-negative organisms, thereby blocking peptidoglycan biosynthesis and compromising cell wall integrity. This inhibition results in cell lysis and rapid bactericidal action, providing therapeutic efficacy in clinical conditions such as uncomplicated urinary tract infections, pyelonephritis, and urosepsis.

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.