Pharmacokinetics of Ertapenem in Patients Aged Over 75

NCT02505386 | Completed Phase 4

• 1 other identifier: CHUBX 2013/12
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

In geriatric departments, physicians are faced with two difficulties, first the increasing number of infections caused by multiresistant bacteria, especially extended spectrum β-lactamase (ESBL) producing enterobacteria strains and second, the poor venous access frequently encountered in elderly population. Giving antibiotics subcutaneously would be an interesting alternative, all the more as intramuscular injection is contraindicated in case the of anticoagulant therapy. Unfortunately, few data are available about subcutaneous (SC) administration. Ertapenem is a recent long-acting parenteral carbapenem indicated especially in the treatment of ESBL infection. Its subcutaneously administration has been tested in several studies in Intensive Care Units (ICU) and internal medicine wards with promising results regarding clinical and pharmacokinetics data. An alternative to the IV Ertapenem administration is needed because of poor venous access and behavioural abnormalities commonly present in infected elderly population. Ertapenem is currently SC administrated in geriatric departments if no other option is available. Moreover elderly patients often present several comorbdities, polymedication, renal insufficiency, cachexia which may disturb antibiotics pharmacokinetics. The aim of the study is to obtain pharmacokinetic data of SC and IV Ertapenem administration in elderly population, obtain PK/PD parameters adapted to time-dependent antibiotics (T%\>MIC) and descriptive data of occurrence of adverse effects and evolution of signs of infection.

Conditions

Infections

Keywords

Ertapenem; Subcutaneously; Aged; Elderly; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Area under the curve established from the minimal concentration

  To determine and compare Area under the curve established from the minimal concentration, Maximal concentration n°1 (at the end of the infusion) and Maximal concentration n°2 (2 hours after the end of the infusion) between intravenous and subcutaneous (SC) routes

  48 hours after ertapenem beginning

Secondary Outcomes (3)

• Time spent over the minimal inhibitory concentration

  48 hours after ertapenem beginning

• Number of Participants with Adverse Events (AE) as a Measure of Safety and Tolerability

  From the ertapenem beginning until 15 days after the end of the treatment

• Proportion of recovery

  At the end of the treatment

Study Arms (2)

Ertapenem IV

ACTIVE COMPARATOR

IV administration of ertapenem

Drug: Ertapenem

Ertapenem SC

EXPERIMENTAL

SC administration of ertapenem

Drug: Ertapenem

Interventions

Ertapenem DRUG

Ertapenem IV; Ertapenem SC

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age\> or equal to 75 years
• Treatment with ertapenem (1g daily) for at least 48 hours IV or SC (or one then the other)
• Subject affiliated or beneficiary of a social security system,
• Free Consent, informed and signed by the participant or by the designation of a proxy if delirium and the investigator.

You may not qualify if:

• Age \< 75 years

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

CHU de Bordeaux

Bordeaux, 33000, France

Location

Related Publications (1)

• Roubaud Baudron C, Legeron R, Ollivier J, Bonnet F, Greib C, Guerville F, Cazanave C, Kobeh D, Cressot V, Moneger N, Videau MN, Thiel E, Foucaud C, Lafargue A, de Thezy A, Durrieu J, Bourdel Marchasson I, Pinganaud G, Breilh D. Is the subcutaneous route an alternative for administering ertapenem to older patients? PHACINERTA study. J Antimicrob Chemother. 2019 Dec 1;74(12):3546-3554. doi: 10.1093/jac/dkz385.

  PMID: 31730164 DERIVED

MeSH Terms

Conditions

Infections

Interventions

Ertapenem

Intervention Hierarchy (Ancestors)

Carbapenems; beta-Lactams; Lactams; Amides; Organic Chemicals; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Claire ROUBAUD BAUDRON, MD

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2014
• First Posted: July 22, 2015
• Study Start: August 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: September 23, 2016

Record last verified: 2016-09

Locations

FR (1)