AntimicrobialsPhASAgeNCT03583749
Pharmacokinetics and Safety of Antimicrobial Agents Administered by Subcutaneous Route in Patients AGEd Over 65 Years
An observational study of Antimicrobials and Subcutaneous Injection, run by University Hospital, Bordeaux at 5 sites in France.
Trial summary
Elderly people are more prone to develop infection with a poorer prognosis compared to young people. Physicians may encounter difficulties regarding antimicrobial agents administration route. In fact, poor venous access and behavioral disturbance are frequent issues. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Antimicrobials, Subcutaneous Injection, Antibiotic
- What is being tested?
- Subcutaneous (SC) route for antibiotic treatment and Intravenous (IV) route for antibiotic treatment
- Type of treatment
- Injection or infusion
- How many people
- 150 participants
- Where
- 5 sitesFrance
- Study dates
- 7 Aug 2019to 5 Sep 2021
- Phase
- Observational
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients will be included during their hospitalization. They may be included if they receive first-line antibiotic treatment or other antibiotic therapy, as long as the time to reach pharmacokinetic steady state has been reached. This project involves patients hospitalized in an infectious and tropical or geriatric ward
Who may be able to join
- Aged over 65
- To receive ceftriaxone (1g daily) or amoxicillin-clavulanate (1g/0.2g every 8h) or piperacillin-tazobactam (4g/0.5g every 8h) by SC or IV infusion (30-60minutes) at steady state (48h, 24h and 24h respectively)
- Free, written and informed consent signed by the participant or by a proxy in case of delirium
Who cannot join
- criteria for legislation (justice protection, subject participating to another research including a period of exclusion)
- previous inclusion in this study
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites, 5 recruiting
- Recruiting
CHU de Bordeaux
Bordeaux, 33000
Claire ROUBAUD-BAUDRON, MD, PhD, +335 57 65 66 10, claire.roubaud@chu-bordeaux.fr
Claire ROUBAUD-BAUDRON, MD, PhD
- Recruiting
Hospital Métropole Savoie
Chambéry, 73000
Emmanuel FORESTIER, MD, +33 (0) 4 79 96 51 72, emmanuel.forestier@ch-metropole-savoie.fr
Emmanuel FORESTIER, MD
- Recruiting
CHU de Grenoble Alpes
Grenoble, 38700
Gaëtan GAVAZZI, MD, PhD, +334 76 76 57 97, ggavazzi@chu-grenoble.fr
Gaëtan GAVAZZI, MD, PhD
- Recruiting
Hospices Civils de Lyon
Lyon, 69000
Tristan FERRY, MD, PhD, +334 72 07 11 07, tristan.ferry@chu-lyon.fr
Tristan FERRY, MD, PhD
- Recruiting
University Hospital, Poitiers
Poitiers, 86021
Marc PACCALIN, MD, PhD, Marc.PACCALIN@chu-poitiers.fr
Marc PACCALIN, MD, PhD
About this study
Elderly people are more prone to develop infection with a poorer prognosis compared to young people. Physicians may encounter difficulties regarding antimicrobial agents administration route. In fact, poor venous access and behavioral disturbance are frequent issues. The subcutaneous (SC) route may be a safe alternative, but sparse data are available in the literature. The present study aims to describe Pharmacokinetics (PK) / Pharmacodynamics (PD) characteristics of antibiotics (amoxicillin/clavulanate, ceftriaxone and piperacillin/tazobactam) subcutaneous administration in patients aged over 65.
Read the detailed description
Antibiotic administration through subcutaneous (SC) injection is common practice in France, especially in Geriatrics as an alternative to intravenous (IV) route in case of poor venous access or delirium (Forestier et al. CMI 2015). Whereas tolerance of such a practice seems to be reasonable (Roubaud-Baudron et al. Age and Ageing 2017), sparse PK/PD data are available. Most PK/PD studies include young and healthy subjects, yet elderly patients often have multimorbidity , poly medication, renal insufficiency and cachexia which may disturb antibiotics PK/PD. Compared to intravenous (IV) route, SC route is less painful and less frequently associated with infectious or thrombotic complication. A recent study carried out in Bordeaux University Hospital comparing PK/PD data on ertapenem SC or IV administrations in patients aged over 75 showed that area under the curve (AUC) and probability to maintain free ertapenem concentration above the Minimum inhibitory concentration (MIC) during at least 40% of time (fT>MIC>40%) were not significantly different (manuscript in progress).
The investigator's hypothesis is that SC administration of amoxicillin-clavulanate, ceftriaxone and piperacillin-tazobactam has favorable pharmacokinetics and acceptable tolerance compared with IV infusion in elderly patients.
Patients receiving one of the three antibiotics by IV or SC route will be included at steady state (depending on antibiotic treatment) for several blood tests (3 or 4 depending of routes choice) and followed until 15 days after completion of antibiotic treatment in order to evaluate tolerance and efficacy of antibiotic treatment. Physicians in charge of patients will decide antibiotic prescription including administration route. The study will not influence these choices because patients will be included after antibiotic initiation.
- Conditions
- Antimicrobials, Subcutaneous Injection, Antibiotic, Older People
- Being tested
- Subcutaneous (SC) route for antibiotic treatment, Intravenous (IV) route for antibiotic treatment
- Keywords
- Antimicrobial agents, subcutaneous administration, safety, pharmacokinetics, elderly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subcutaneous (SC) route for antibiotic treatmentDrug
Patients receiving one of the three antibiotics by SC route without any randomization because the route will be chosen before inclusion by the physician in charge.
Intravenous (IV) route for antibiotic treatmentDrug
Patients receiving one of the three antibiotics by IV route without any randomization because the route will be chosen before inclusion by the physician in charge.
| Study group | Role | What they receive |
|---|---|---|
| amoxicillin-clavulanate | followed of SC and IV cohort without any randomization because the route will be chosen before inclusion by the physician in charge. Receives: Drug: Subcutaneous (SC) route for antibiotic treatment; Drug: Intravenous (IV) route for antibiotic treatment | |
| ceftriaxone | followed of SC and IV cohort without any randomization because the route will be chosen before inclusion by the physician in charge. Receives: Drug: Subcutaneous (SC) route for antibiotic treatment; Drug: Intravenous (IV) route for antibiotic treatment | |
| piperacillin-tazobactam | followed of SC and IV cohort without any randomization because the route will be chosen before inclusion by the physician in charge. Receives: Drug: Subcutaneous (SC) route for antibiotic treatment; Drug: Intravenous (IV) route for antibiotic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma antibiotic concentrations
Describe and compare pharmacokinetics of amoxicillin-clavulanate, ceftriaxone and piperacillin-tazobactam administered by SC and IV routes
Measured: Day 1
Secondary outcomes (3)
Number of adverse events
Occurrence of adverse events (AEs) up to 15 days after the end of local antibiotherapy (edema, pain, erythema, necrosis) and systemic (AEs described in the Summary of Product Characteristics for antibiotics)
Measured: Day 21
Number of infection cure
rate of infection cure at the end of antibiotic treatment up to 15 days after the end of antibiotic therapy
Measured: Day 21
Number of hospitalisation days
Describe the times of hospitalisation
Measured: Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2018
- Study start7 Aug 2019
- Primary completion5 Sep 2021 (estimated)
- Study completion5 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AntimicrobialsStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claire ROUBAUD-BAUDRON, MD, PhD, Principal investigator, Hospital University, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03583749
- Sponsor's protocol ID
- CHUBX 2017/37
- Acronym
- PhASAge
- Status last verified
- Feb 2021
- First submitted
- 28 Jun 2018
- Last updated
- 16 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics and Safety of Antimicrobial Agents Administered by Subcutaneous Route in Patients AGEd Over 65 Years
- ClinicalTrials.gov ID
- NCT03583749
- Acronym / sponsor ID
- PhASAge / CHUBX 2017/37
- Conditions
- Antimicrobials, Subcutaneous Injection, Antibiotic, Older People
- Keywords
- Antimicrobial agents, subcutaneous administration, safety, pharmacokinetics, elderly
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 7 Aug 2019 (actual)
- Primary completion
- 5 Sep 2021 (estimated)
- Study completion
- 5 Sep 2021 (estimated)
- First posted
- 11 Jul 2018 (actual)
- 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.
Elderly people are more prone to develop infection with a poorer prognosis compared to young people. Physicians may encounter difficulties regarding antimicrobial agents administration route. In fact, poor venous access and behavioral disturbance are frequent issues. The subcutaneous (SC) route may be a safe alternative, but sparse data are available in the literature. The present study aims to describe Pharmacokinetics (PK) / Pharmacodynamics (PD) characteristics of antibiotics (amoxicillin/clavulanate, ceftriaxone and piperacillin/tazobactam) subcutaneous administration in patients aged over 65.
Detailed description
Antibiotic administration through subcutaneous (SC) injection is common practice in France, especially in Geriatrics as an alternative to intravenous (IV) route in case of poor venous access or delirium (Forestier et al. CMI 2015). Whereas tolerance of such a practice seems to be reasonable (Roubaud-Baudron et al. Age and Ageing 2017), sparse PK/PD data are available. Most PK/PD studies include young and healthy subjects, yet elderly patients often have multimorbidity , poly medication, renal insufficiency and cachexia which may disturb antibiotics PK/PD. Compared to intravenous (IV) route, SC route is less painful and less frequently associated with infectious or thrombotic complication. A recent study carried out in Bordeaux University Hospital comparing PK/PD data on ertapenem SC or IV administrations in patients aged over 75 showed that area under the curve (AUC) and probability to maintain free ertapenem concentration above the Minimum inhibitory concentration (MIC) during at least 40% of time (fT>MIC>40%) were not significantly different (manuscript in progress).
The investigator's hypothesis is that SC administration of amoxicillin-clavulanate, ceftriaxone and piperacillin-tazobactam has favorable pharmacokinetics and acceptable tolerance compared with IV infusion in elderly patients.
Patients receiving one of the three antibiotics by IV or SC route will be included at steady state (depending on antibiotic treatment) for several blood tests (3 or 4 depending of routes choice) and followed until 15 days after completion of antibiotic treatment in order to evaluate tolerance and efficacy of antibiotic treatment. Physicians in charge of patients will decide antibiotic prescription including administration route. The study will not influence these choices because patients will be included after antibiotic initiation.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| amoxicillin-clavulanate | – | Drug: Subcutaneous (SC) route for antibiotic treatment, Drug: Intravenous (IV) route for antibiotic treatmentfollowed of SC and IV cohort without any randomization because the route will be chosen before inclusion by the physician in charge. |
| ceftriaxone | – | Drug: Subcutaneous (SC) route for antibiotic treatment, Drug: Intravenous (IV) route for antibiotic treatmentfollowed of SC and IV cohort without any randomization because the route will be chosen before inclusion by the physician in charge. |
| piperacillin-tazobactam | – | Drug: Subcutaneous (SC) route for antibiotic treatment, Drug: Intravenous (IV) route for antibiotic treatmentfollowed of SC and IV cohort without any randomization because the route will be chosen before inclusion by the physician in charge. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients will be included during their hospitalization. They may be included if they receive first-line antibiotic treatment or other antibiotic therapy, as long as the time to reach pharmacokinetic steady state has been reached. This project involves patients hospitalized in an infectious and tropical or geriatric ward
Key inclusion criteria (3 listed)
- Aged over 65
- To receive ceftriaxone (1g daily) or amoxicillin-clavulanate (1g/0.2g every 8h) or piperacillin-tazobactam (4g/0.5g every 8h) by SC or IV infusion (30-60minutes) at steady state (48h, 24h and 24h respectively)
- Free, written and informed consent signed by the participant or by a proxy in case of delirium
Key exclusion criteria (2 listed)
- criteria for legislation (justice protection, subject participating to another research including a period of exclusion)
- previous inclusion in this study
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 |
|---|---|---|
| Subcutaneous (SC) route for antibiotic treatmentPatients receiving one of the three antibiotics by SC route without any randomization because the route will be chosen before inclusion by the physician in charge. | Drug | amoxicillin-clavulanate, ceftriaxone, piperacillin-tazobactam |
| Intravenous (IV) route for antibiotic treatmentPatients receiving one of the three antibiotics by IV route without any randomization because the route will be chosen before inclusion by the physician in charge. | Drug | amoxicillin-clavulanate, ceftriaxone, piperacillin-tazobactam |
Primary outcome
Plasma antibiotic concentrations
Time frame: Day 1
Describe and compare pharmacokinetics of amoxicillin-clavulanate, ceftriaxone and piperacillin-tazobactam administered by SC and IV routes
3 secondary outcomes
Number of adverse events
Time frame: Day 21
Number of infection cure
Time frame: Day 21
Number of hospitalisation days
Time frame: Day 21
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2021.
- Individual participant dataSharing planned: No
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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, PhD principal investigator
Hospital University, Bordeaux
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Antimicrobials and Subcutaneous Injection, run by University Hospital, Bordeaux at 5 sites 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 3 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: status not confirmed, as of the sponsor's last update on 16 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Claire ROUBAUD-BAUDRON, MD, PhD (+33 (0) 5 57 82 18 44, claire.roubaud@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma antibiotic concentrations (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Feb 2021.