InfectionAMOCEFNCT01581047
Pharmacokinetics of Small Spectrum Beta-lactam Antibiotics (Amoxicillin/Clavulanic Acid and Cefuroxime) in Patients on Intensive Care Units
An observational study of Infection, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Adequate antibiotic therapy is very important in the treatment of infections. Spectrum and dosing of the antibiotics are two factors of the therapy: the spectrum of an antibiotic can't be changed, but the dosing scheme can be optimized. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection
- How many people
- 37 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Mar 2012to 7 May 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients on the intensive care unit, with an infection (which requires amoxicillin/clavulanic acid or cefuroxime).
Who may be able to join
- patients on the intensive care unit, who are treated with amoxicillin/clavulanic acid or cefuroxime for an infection
Who cannot join
- informed consent lacking
- haematocrit < 21 %
- arterial catheter lacking
Trial locations and contacts
1 site in 1 country.
About this study
Adequate antibiotic therapy is very important in the treatment of infections. Spectrum and dosing of the antibiotics are two factors of the therapy: the spectrum of an antibiotic can't be changed, but the dosing scheme can be optimized. Recent studies proved that an optimized dosing scheme can improve the efficacy of the treatment. Broad-spectrum antibiotics have unpredictable pharmacokinetics in patients on intensive care units. This is due to the pathophysiologic processes in the patients on intensive care units: increased distribution volume, hypoproteinemia, organ failure… The investigators guess that similar processes influence the pharmacokinetics of small spectrum antibiotics (like amoxicillin and cefuroxime), but data lacks. Because the pharmacokinetics of broad spectrum antibiotics in seriously ill patients are better known, physicians are more confident prescribing these drugs. Studying the pharmacokinetic interactions of small spectrum antibiotics in seriously ill patients, can help to give the physician the confidence to prescribe these small-spectrum antibiotics.
In this study, the investigators will study the pharmacokinetics of amoxicillin/clavulanic acid and cefuroxime, in 60 patients on intensive care. 8 blood samples will be drawn via a central catheter on different moments after one administration of the antibiotic in the steady state phase. All the patients are prescribed the antibiotics for the treatment of their infections: they get the antibiotic therapy anyway. By measuring the concentrations on different moments after one administration, the investigators can reconstruct the pharmacokinetic function.
- Conditions
- Infection
- Keywords
- amoxicillin, clavulanic acid, cefuroxime, Patients in the intensive care unit, with an infection which requires amoxicillin/clavulanic acid or cefuroxime
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Amoxicillin/Clavulanic Acid | Patients in the intensive care unit, with an infection which will be treated with Amoxicillin/Clavulanic Acid. | |
| Cefuroxime | Patients in the intensive care unit, with an infection which will be treated with Cefuroxime. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the serum concentration versus time curve (AUC) of Amoxicillin/Clavulanic acid.
The concentrations of the antibiotic in serum samples, drawn at various times after one administration, will be measured. With these data, we can calculate the time above the minimal inhibitory concentration (MIC).
Measured: Before and at 15, 30, 45, 60, 120, 240 and 360 minutes after administration
Area under the serum concentration versus time curve (AUC) of Cefuroxime.
The concentrations of the antibiotic in serum samples, drawn at various times after one administration, will be measured. With these data, we can calculate the time above the minimal inhibitory concentration (MIC).
Measured: Before and at 15, 30, 45, 60, 120, 240 and 480 minutes after administration
Secondary outcomes (6)
Severity of disease classification.
This will be assessed using the Acute Physiology and Chronic Health Evaluation II (APACHE2)-score.
Measured: At date of admission (day 1) and dismissal (up to 3 months).
Rate of organ failure.
This will be assessed using the Sequential Organ Failure Assessment score (SOFA-score).
Measured: At date of admission (day 1) and dismissal (up to 3 months).
Concentration serum creatinin
Measured: At day 1.
24 hour urine creatinine clearance
Urine will be collected during 24 hours to measure the urine creatinine clearance.
Measured: At 24 hours
Change in fluid balance
Change in fluid balance will be measured.
Measured: From 0 to 24 hours.
Concentration serum albumin
Measured: At day 1.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2012 (estimated)
- Study start15 Mar 2012
- Primary completion21 Jan 2014
- Study completion7 May 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jan De Waele, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01581047
- Sponsor's protocol ID
- 2012/078
- Other IDs
- 2011-006107-35
- Acronym
- AMOCEF
- Status last verified
- Sep 2023
- First submitted
- 15 Feb 2012
- Last updated
- 5 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Small Spectrum Beta-lactam Antibiotics (Amoxicillin/Clavulanic Acid and Cefuroxime) in Patients on Intensive Care Units
- ClinicalTrials.gov ID
- NCT01581047
- Acronym / sponsor ID
- AMOCEF / 2012/078
- Conditions
- Infection
- Keywords
- amoxicillin, clavulanic acid, cefuroxime, Patients in the intensive care unit, with an infection which requires amoxicillin/clavulanic acid or cefuroxime
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 15 Mar 2012 (actual)
- Primary completion
- 21 Jan 2014 (actual)
- Study completion
- 7 May 2014 (actual)
- First posted
- 19 Apr 2012 (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.
Adequate antibiotic therapy is very important in the treatment of infections. Spectrum and dosing of the antibiotics are two factors of the therapy: the spectrum of an antibiotic can't be changed, but the dosing scheme can be optimized. Recent studies proved that an optimized dosing scheme can improve the efficacy of the treatment. Broad-spectrum antibiotics have unpredictable pharmacokinetics in patients on intensive care units. This is due to the pathophysiologic processes in the patients on intensive care units: increased distribution volume, hypoproteinemia, organ failure… The investigators guess that similar processes influence the pharmacokinetics of small spectrum antibiotics (like amoxicillin and cefuroxime), but data lacks. Because the pharmacokinetics of broad spectrum antibiotics in seriously ill patients are better known, physicians are more confident prescribing these drugs. Studying the pharmacokinetic interactions of small spectrum antibiotics in seriously ill patients, can help to give the physician the confidence to prescribe these small-spectrum antibiotics.
In this study, the investigators will study the pharmacokinetics of amoxicillin/clavulanic acid and cefuroxime, in 60 patients on intensive care. 8 blood samples will be drawn via a central catheter on different moments after one administration of the antibiotic in the steady state phase. All the patients are prescribed the antibiotics for the treatment of their infections: they get the antibiotic therapy anyway. By measuring the concentrations on different moments after one administration, the investigators can reconstruct the pharmacokinetic function.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amoxicillin/Clavulanic Acid | – | –Patients in the intensive care unit, with an infection which will be treated with Amoxicillin/Clavulanic Acid. |
| Cefuroxime | – | –Patients in the intensive care unit, with an infection which will be treated with Cefuroxime. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients on the intensive care unit, with an infection (which requires amoxicillin/clavulanic acid or cefuroxime).
Key inclusion criteria (1 listed)
- patients on the intensive care unit, who are treated with amoxicillin/clavulanic acid or cefuroxime for an infection
Key exclusion criteria (3 listed)
- informed consent lacking
- haematocrit < 21 %
- arterial catheter lacking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Area under the serum concentration versus time curve (AUC) of Amoxicillin/Clavulanic acid.
Time frame: Before and at 15, 30, 45, 60, 120, 240 and 360 minutes after administration
The concentrations of the antibiotic in serum samples, drawn at various times after one administration, will be measured. With these data, we can calculate the time above the minimal inhibitory concentration (MIC).
Area under the serum concentration versus time curve (AUC) of Cefuroxime.
Time frame: Before and at 15, 30, 45, 60, 120, 240 and 480 minutes after administration
The concentrations of the antibiotic in serum samples, drawn at various times after one administration, will be measured. With these data, we can calculate the time above the minimal inhibitory concentration (MIC).
6 secondary outcomes
Severity of disease classification.
Time frame: At date of admission (day 1) and dismissal (up to 3 months).
Rate of organ failure.
Time frame: At date of admission (day 1) and dismissal (up to 3 months).
Concentration serum creatinin
Time frame: At day 1.
24 hour urine creatinine clearance
Time frame: At 24 hours
Change in fluid balance
Time frame: From 0 to 24 hours.
Concentration serum albumin
Time frame: At day 1.
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 5 Sep 2023.
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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.
Jan De Waele, MD, PhD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infection, run by University Hospital, Ghent at 1 site in Belgium.
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 1 inclusion and 3 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 5 Sep 2023. 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 Belgium. 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?
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 serum concentration versus time curve (AUC) of Amoxicillin/Clavulanic acid. (time frame: Before and at 15, 30, 45, 60, 120, 240 and 360 minutes after administration). The study lists 2 primary outcomes in all. 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 5 Sep 2023.