Infection During HemodialysisPhase 3NCT02007603
Concentration of Ampicillin / Sulbactam and Amoxicillin / Clavulanic Acid in the Blood During Renal Replacement Therapy in Longterm Renal Replacement Therapy Patients
A Phase 3 study testing Administration of Amoxicillin / clavulanic acid, Ampicillin / sulbactam and Blooddraws for pharmacokinetic profiling in people with Infection During Hemodialysis, run by Medical University of Vienna at 1 site in Austria.
Trial summary
The study will be conducted to investigate the pharmacokinetics of ampicillin / sulbactam and amoxicillin/clavulanic acid during intermittent haemodialysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection During Hemodialysis
- What is being tested?
- Administration of Amoxicillin / clavulanic acid, Ampicillin / sulbactam and Blooddraws for pharmacokinetic profiling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteAustria
- Study dates
- Aug 2013to May 2017
- Phase
- Phase 3
- 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
Who may be able to join
- Age >18 years
- Suspected or proven bacterial infection requiring parenteral antibiotic therapy.
- Renal replacement therapy (HD)
Who cannot join
- Known hypersensitivity to ampicillin / sulbactam, amoxicillin / clavulanic acid or other beta-lactames, or severe hypersensitivity (anaphylactic reaction) to beta-lactam antibacterial agents.
- An expected survival of less than two days.
- Known pregnancy
- Co-administration of one of the following drugs: probenecid which cannot be discontinued for the duration of the study
- Ampicillin / sulbactam respectively amoxicillin / clavulanic acid as monotherapy for resistant species or fungal infections.
- Other reasons opposing the study participation on the discretion of the investigators.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multiple-dose Pharmacokinetics of Ampicillin / Sulbactam and Amoxicillin / Clavulanic Acid During Haemodialysis in Longterm Haemodialysis Patients
The study will be conducted to investigate the pharmacokinetics of ampicillin / sulbactam and amoxicillin/clavulanic acid during intermittent haemodialysis.
- Conditions
- Infection During Hemodialysis
- Being tested
- Administration of Amoxicillin / clavulanic acid, Ampicillin / sulbactam, Blooddraws for pharmacokinetic profiling
- Keywords
- chronic hemodialysis, ampicillin, sulbactam, amoxicillin, clavulanic acid, pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of Amoxicillin / clavulanic acidDrug
Patients receive amoxicillin / clavulanic acid due to clinical necessity
Ampicillin / sulbactamDrug
Patients receive ampicillin / sulbactam due to clinical necessity
Blooddraws for pharmacokinetic profilingProcedure or surgery
Blood will be sampled at multiple timepoints during multiple hemodialysis sessions
| Study group | Role | What they receive |
|---|---|---|
| Ampicillin / sulbactam | Experimental | Patients are randomized to the ampicillin / sulbactam arm. Pharmacokinetic samples will be taken during multiple hemodialysis sessions. Receives: Drug: Ampicillin / sulbactam; Procedure: Blooddraws for pharmacokinetic profiling |
| Amoxicillin / clavulanic acid | Experimental | Patients are randomized to the amoxicillin / clavulanic acid arm. Pharmacokinetic samples will be taken during multiple hemodialysis sessions. Receives: Drug: Administration of Amoxicillin / clavulanic acid; Procedure: Blooddraws for pharmacokinetic profiling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Influence of hemodialysis on the area under concentration curve of ampicillin/sulbactam and amoxicillin / clavulanic acid plasma concentration levels.
Pharmacokinetic samples are drawn on multiple timepoints from each patient during his participation.
Measured: day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2013 (estimated)
- Study startAug 2013
- Primary completionFeb 2015
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection During HemodialysisStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Florian Thalhammer, Medical University of Vienna
- Investigators
- Florian Thalhammer, Prof. MD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02007603
- Sponsor's protocol ID
- AMPISUL/AMOXICLAV-HD_V1.4
- Status last verified
- May 2017
- First submitted
- 16 Oct 2013
- Last updated
- 31 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiple-dose Pharmacokinetics of Ampicillin / Sulbactam and Amoxicillin / Clavulanic Acid During Haemodialysis in Longterm Haemodialysis Patients
- ClinicalTrials.gov ID
- NCT02007603
- Acronym / sponsor ID
- AMPISUL/AMOXICLAV-HD_V1.4
- Conditions
- Infection During Hemodialysis
- Keywords
- chronic hemodialysis, ampicillin, sulbactam, amoxicillin, clavulanic acid, pharmacokinetics
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Aug 2013 (actual)
- Primary completion
- Feb 2015 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 11 Dec 2013 (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.
The study will be conducted to investigate the pharmacokinetics of ampicillin / sulbactam and amoxicillin/clavulanic acid during intermittent haemodialysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ampicillin / sulbactam | Experimental | Drug: Ampicillin / sulbactam, Procedure: Blooddraws for pharmacokinetic profilingPatients are randomized to the ampicillin / sulbactam arm. Pharmacokinetic samples will be taken during multiple hemodialysis sessions. |
| Amoxicillin / clavulanic acid | Experimental | Drug: Administration of Amoxicillin / clavulanic acid, Procedure: Blooddraws for pharmacokinetic profilingPatients are randomized to the amoxicillin / clavulanic acid arm. Pharmacokinetic samples will be taken during multiple hemodialysis sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age >18 years
- Suspected or proven bacterial infection requiring parenteral antibiotic therapy.
- Renal replacement therapy (HD)
Key exclusion criteria (6 listed)
- Known hypersensitivity to ampicillin / sulbactam, amoxicillin / clavulanic acid or other beta-lactames, or severe hypersensitivity (anaphylactic reaction) to beta-lactam antibacterial agents.
- An expected survival of less than two days.
- Known pregnancy
- Co-administration of one of the following drugs: probenecid which cannot be discontinued for the duration of the study
- Ampicillin / sulbactam respectively amoxicillin / clavulanic acid as monotherapy for resistant species or fungal infections.
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 |
|---|---|---|
| Administration of Amoxicillin / clavulanic acidPatients receive amoxicillin / clavulanic acid due to clinical necessity | Drug | Amoxicillin / clavulanic acid |
| Ampicillin / sulbactamPatients receive ampicillin / sulbactam due to clinical necessity | Drug | Ampicillin / sulbactam |
| Blooddraws for pharmacokinetic profilingBlood will be sampled at multiple timepoints during multiple hemodialysis sessions | Procedure or surgery | Amoxicillin / clavulanic acid, Ampicillin / sulbactam |
Primary outcome
Influence of hemodialysis on the area under concentration curve of ampicillin/sulbactam and amoxicillin / clavulanic acid plasma concentration levels.
Time frame: day 15
Pharmacokinetic samples are drawn on multiple timepoints from each patient during his participation.
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 31 May 2017.
Related trials for Infection During Hemodialysis
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Acute Kidney Injury, Sepsis
RecruitingPhase 4
Using Antibiotics to Prevent Infections in Hemodialysis Patients During Catheter Placement
Infection Catheter-Related
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.
Florian Thalhammer, Prof. MD principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Administration of Amoxicillin / clavulanic acid, Ampicillin / sulbactam and Blooddraws for pharmacokinetic profiling in people with Infection During Hemodialysis, run by Medical University of Vienna at 1 site in Austria.
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 6 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 31 May 2017. 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 Austria. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Influence of hemodialysis on the area under concentration curve of ampicillin/sulbactam and amoxicillin / clavulanic acid plasma concentration levels. (time frame: day 15). 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 31 May 2017.