InfectionsPhase 4PHACINERTANCT02505386
Pharmacokinetics of Ertapenem in Patients Aged Over 75
A Phase 4 study testing Ertapenem in people with Infections, run by University Hospital, Bordeaux at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Infections
- What is being tested?
- Ertapenem
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2014to Aug 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- Age < 75 years
- Criteria for legislation: those under protection of the justice, subject participating in other research, including a period of exclusion still going to pre-inclusion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacokinetics of Ertapenem Following Subcutaneous or Intravenous Infusion in Patients Aged Over 75 (PHACINERTA)
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.
Read the detailed description
ESBL infection incidence increases especially in elderly population (Observatoire National de l'Epidémiologie de la Résistance Bactérienne aux Antibiotiques (ONERBA) www.onerba.org). SC antibiotic route is sometimes the only option available for infected elderly patients (delirium, dementia or no venous access) and presents advantages like greater patient comfort, less nursing time and decrease hospital duration. Ertapenem has a relatively long half life (4 hours) compared to imipenem (1 hour) and a less broad spectrum. Two studies compared the ertapenem pharmacokinetics regarding IV or SC administration. The first concerned 6 patients admitted in ICU and the second 16 patients in internal medicine department. They found IV and SC administrations were equivalent considering that ertapenem antimicrobial activity was time dependent. In fact, a reduction of peak concentration and of time to peak concentration was observed in both studies, but the Area Under the Curve were similar especially the time spent over the Minimal Inhibitory Concentration. Both studies did not observe any severe adverse effects. Because of these promising results and despite not being approved yet, SC Ertapenem, is commonly used in geriatric department. This administration route is chosen when no other option is available, for instance in cases of behavioural disturbance and lack of venous access.
The objective of the investigators study is to confirm the pharmacokinetics data in elderly population known to present frequently renal insufficiency and denutrition and to document the occurrence of adverse effects and clinical evolution.
Patients over 75 receiving ertapenem for 48 hours (IV or SC) will be included. Ertapenem concentrations (H0, H+0.5h and H+2.5h) will be determined at steady state and described based on administration route. Systemic and local adverse effects will be collected during the treatment and infection evolution will be described.
Patients will be monitored during ertapenem treatment and for 45 days after the beginning of the treatment. Biological data will be obtained initially at inclusion (D3 after ertapenem beginning) and for 14 days (+/-10) after the beginning of the treatment (corresponding to end of treatment). Signs of infection evolution will be also monitored for 45 days (+/-10).
- Conditions
- Infections
- Being tested
- Ertapenem
- Keywords
- Ertapenem, Subcutaneously, Aged, Elderly, Pharmacokinetics
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErtapenemDrug
| Study group | Role | What they receive |
|---|---|---|
| Ertapenem IV | Active comparator | IV administration of ertapenem Receives: Drug: Ertapenem |
| Ertapenem SC | Experimental | SC administration of ertapenem Receives: Drug: Ertapenem |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 48 hours after ertapenem beginning
Secondary outcomes (3)
Time spent over the minimal inhibitory concentration
To assess the time spent over the minimal inhibitory concentration
Measured: 48 hours after ertapenem beginning
Number of Participants with Adverse Events (AE) as a Measure of Safety and Tolerability
To assess and graduate the number of AE
Measured: From the ertapenem beginning until 15 days after the end of the treatment
Proportion of recovery
To assess the efficacy of the treatment
Measured: At the end of the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2015 (estimated)
- Study startAug 2014
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfectionsStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claire ROUBAUD BAUDRON, MD, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02505386
- Sponsor's protocol ID
- CHUBX 2013/12
- Acronym
- PHACINERTA
- Status last verified
- Sep 2016
- First submitted
- 4 Aug 2014
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31730164
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Ertapenem Following Subcutaneous or Intravenous Infusion in Patients Aged Over 75 (PHACINERTA)
- ClinicalTrials.gov ID
- NCT02505386
- Acronym / sponsor ID
- PHACINERTA / CHUBX 2013/12
- Conditions
- Infections
- Keywords
- Ertapenem, Subcutaneously, Aged, Elderly, Pharmacokinetics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 22 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
ESBL infection incidence increases especially in elderly population (Observatoire National de l'Epidémiologie de la Résistance Bactérienne aux Antibiotiques (ONERBA) www.onerba.org). SC antibiotic route is sometimes the only option available for infected elderly patients (delirium, dementia or no venous access) and presents advantages like greater patient comfort, less nursing time and decrease hospital duration. Ertapenem has a relatively long half life (4 hours) compared to imipenem (1 hour) and a less broad spectrum. Two studies compared the ertapenem pharmacokinetics regarding IV or SC administration. The first concerned 6 patients admitted in ICU and the second 16 patients in internal medicine department. They found IV and SC administrations were equivalent considering that ertapenem antimicrobial activity was time dependent. In fact, a reduction of peak concentration and of time to peak concentration was observed in both studies, but the Area Under the Curve were similar especially the time spent over the Minimal Inhibitory Concentration. Both studies did not observe any severe adverse effects. Because of these promising results and despite not being approved yet, SC Ertapenem, is commonly used in geriatric department. This administration route is chosen when no other option is available, for instance in cases of behavioural disturbance and lack of venous access.
The objective of the investigators study is to confirm the pharmacokinetics data in elderly population known to present frequently renal insufficiency and denutrition and to document the occurrence of adverse effects and clinical evolution.
Patients over 75 receiving ertapenem for 48 hours (IV or SC) will be included. Ertapenem concentrations (H0, H+0.5h and H+2.5h) will be determined at steady state and described based on administration route. Systemic and local adverse effects will be collected during the treatment and infection evolution will be described.
Patients will be monitored during ertapenem treatment and for 45 days after the beginning of the treatment. Biological data will be obtained initially at inclusion (D3 after ertapenem beginning) and for 14 days (+/-10) after the beginning of the treatment (corresponding to end of treatment). Signs of infection evolution will be also monitored for 45 days (+/-10).
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ertapenem IV | Active comparator | Drug: ErtapenemIV administration of ertapenem |
| Ertapenem SC | Experimental | Drug: ErtapenemSC administration of ertapenem |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Age < 75 years
- Criteria for legislation: those under protection of the justice, subject participating in other research, including a period of exclusion still going to pre-inclusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ertapenem | Drug | Ertapenem IV, Ertapenem SC |
Primary outcome
Area under the curve established from the minimal concentration
Time frame: 48 hours after ertapenem beginning
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
3 secondary outcomes
Time spent over the minimal inhibitory concentration
Time frame: 48 hours after ertapenem beginning
Number of Participants with Adverse Events (AE) as a Measure of Safety and Tolerability
Time frame: From the ertapenem beginning until 15 days after the end of the treatment
Proportion of recovery
Time frame: At the end of the treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Results publication: PubMed 31730164Roubaud 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claire ROUBAUD BAUDRON, MD principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ertapenem in people with Infections, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the curve established from the minimal concentration (time frame: 48 hours after ertapenem beginning). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02505386, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.