NCT03557840: TEMODELTA

Plasma Protein Binding and PK/PD of Total and Unbound Temocillin Non-ICU Patients

Status unknown NA Last updated 31 May 2022

What this trial tests

NA trial testing temocillin in Pharmacokinetics in 60 participants. Status unknown.

Timeline

1 April 2019

Primary endpoint
1 April 2023

1 April 2023

Quick facts

Lead sponsor	Paul M. Tulkens
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	60
Start date	1 April 2019
Primary completion	1 April 2023
Estimated completion	1 April 2023
Sites	1 location across Belgium

Drugs / interventions tested

• temocillin — full drug profile →

Conditions studied

• Pharmacokinetics — all drugs for Pharmacokinetics →
• Antibacterial Agents — all drugs for Antibacterial Agents →
• Infections, Bacterial — all drugs for Infections, Bacterial →
• Infection — all drugs for Infection →

Sponsor

Paul M. Tulkens

Who can join

18 and older, any sex, with Pharmacokinetics or Antibacterial Agents. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Multidrug resistance towards Gram-negative pathogens makes essential the re-examination of older compounds. Temocillin is a penicillin originally marketed in the 1980s but then largely abandoned. It, however, shows a marked ß-lactamase stability (including most classical and extended-spectrum TEM, SHV, CTX-M enzymes and AmpC ß-lactamase). Temocillin is approved for the treatment of bacterial infections of the chest, the lungs, the kidney, the bladder, as well as bacterial infections of the bloodstream and wound infections.

Temocillin efficacy depends primarily from the time interval during which the unbound plasma concentration remains above the minimal inhibitory concentration (MIC) of the antibiotic against the target organism(s). Unfortunately, no comprehensive pharmacokinetic data are available in non-critically-ill patients.

The primary objective of the study is characterize the pharmacokinetics of total and unbound temocillin in non-ICU patients, and, on this basis, to propose optimized dosage regimens in this population. The secondary objectives are (i) to look for possible correlations between the plasma protein profile and the unbound temocillin concentrations; (ii) to investigate the impact of the level and nature of circulating plasma proteins on the unbound temocillin concentration.

The study will be non-randomized, uncontrolled, prospective, open label, interventional, and monocentric. It will include a population pharmacokinetic-pharmacodynamic analysis of the data obtained. The study will enroll patients ≥ 18 years in need of a treatment with temocillin for (i) complicated urinary tract infection and pyelonephritis (associated or not with bacteremia), or (ii) lower respiratory tract infection, or (iii) abdominal infection, and requiring ≥ 4 days of hospitalization. Blood samples will be obtained at day 0 (control) and after 2 and 4 days of drug treatment (full pharmacokinetic evaluation over 8 to 12 h post-administration). Total and unbound temocillin concentrations in plasma will be quantified by a validated analytical method.

A population pharmacokinetic/pharmacodynamics model of plasma total and unbound concentrations of temocillin will be obtained by Bayesian algorithms using Pmetrics software, driven by the predicted plasma total and unbound concentration. The model will be used to assess the probability of target attainment of temocillin.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Temocillin: A Narrative Review of Its Clinical Reappraisal.
   Cosimi L, Zerbato V, Grasselli Kmet N, Oliva A, et al · · 2025 · cited 1× · PMID 41009838 · DOI 10.3390/antibiotics14090859