Surgical Wound InfectionPhase 4ANTIBIOTIKANCT07896239
Antibiotic Tissue Penetration and Tissue Response in Head and Neck Infection and Reconstructive Surgery
A Phase 4 study testing Cefuroxime, Dicloxacillin and Cloxacillin in people with Surgical Wound Infection and Neck Infection, run by Tejs Ehlers Klug at 1 site in Denmark.
Trial summary
The goal of this study is to measure how well commonly used antibiotics reach the tissue in the head and neck region in adults with a postoperative neck infection or undergoing reconstructive nasal surgery with an inferior turbinate flap. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Wound Infection, Neck Infection, Nasal Reconstruction
- What is being tested?
- Cefuroxime, Dicloxacillin and Cloxacillin
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2026to Dec 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- Signed informed consent
- Either a postoperative infection in the neck (sub-study 1) or planned reconstruction with an inferior turbinate flap (sub-study 2)
- Age 18 years or older
Who cannot join
- Known allergy or hypersensitivity to any of the study antibiotics (cefuroxime, cloxacillin, dicloxacillin, or amoxicillin/clavulanic acid)
- eGFR below 30 mL/min/1.73 m2
- Pregnancy or planned pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site
Aarhus University Hospital, Department of Otorhinolaryngology, Head and Neck Surgery
Aarhus N, 8200
About this study
Official title: Antibiotic Penetration and Tissue Response in Infection and Reconstructive Surgery of the Head and Neck Region: A Microdialysis Study of Cefuroxime, Cloxacillin, Dicloxacillin, and Amoxicillin/Clavulanic Acid
The goal of this study is to measure how well commonly used antibiotics reach the tissue in the head and neck region in adults with a postoperative neck infection or undergoing reconstructive nasal surgery with an inferior turbinate flap. The study also describes markers of ischemia and inflammation in the newly created flap during the first days after surgery.
The main question it aims to answer is: For how long do the free concentrations of cefuroxime, cloxacillin, dicloxacillin, and amoxicillin/clavulanic acid stay above the minimal inhibitory concentration (T>MIC) in infected tissue, non-infected tissue, the flap, and plasma?
Participants will receive the antibiotics on a fixed, protocol-defined schedule for about two days. Small microdialysis catheters will be placed in the tissue to collect fluid continuously, and serial blood samples will be drawn. Participation ends when the last sample is collected and the catheters are removed.
Read the detailed description
Infections in the head and neck region and reconstructive surgery in the nasal and sinus area are associated with considerable morbidity and require effective antibiotic treatment. Treatment is based mainly on systemic antibiotic concentrations, but little is known about actual tissue penetration in infected tissue and in reconstructed flaps, where perfusion, edema, ischemia, and inflammation may alter drug distribution. Microdialysis is a minimally invasive method for continuous sampling of free, pharmacologically active drug concentrations and metabolic and inflammatory markers in the extracellular fluid.
This is a prospective, non-randomized, open-label, exploratory interventional study with two sub-studies and a total of 16 participants. All study drugs are marketed antibiotics used in routine clinical practice; they are administered in a protocol-defined regimen to allow pharmacokinetic sampling.
Sub-study 1 (n=8): Adults admitted with a postoperative infection in the neck. Treatment is started on day 1 with cefuroxime 750 mg IV four times daily and dicloxacillin 1000 mg orally four times daily. On day 2, microdialysis catheters are placed in infected and non-infected subcutaneous tissue of the neck, and sampling is performed over two consecutive dosing intervals: (1) cefuroxime 750 mg IV plus dicloxacillin 1000 mg orally, sampled for 6 hours; and (2) cefuroxime 1500 mg IV plus cloxacillin 1000 mg IV, sampled for 8 hours. This allows comparison of two cefuroxime doses and of oral dicloxacillin versus intravenous cloxacillin.
Sub-study 2 (n=8): Adults undergoing reconstructive surgery with an inferior turbinate flap (IFT flap). Postoperatively, amoxicillin/clavulanic acid 500/125 mg and dicloxacillin 1000 mg are given orally three times daily. Microdialysis catheters are placed in the flap and in the nasal septal mucosa (reference tissue). Ischemia markers (glucose, lactate, pyruvate, glycerol) and inflammatory proteins are sampled hourly during the first 6 postoperative hours and in the morning and evening of day 2. Antibiotic concentrations are measured over one dosing interval after the morning dose on day 2.
In both sub-studies, dialysate is collected in 30-60 minute intervals and serial blood samples are drawn for plasma concentrations. Catheters are calibrated in vivo at the end of sampling. Drug concentrations are analysed by LC-MS. Clinically indicated treatment can be changed by the treating physician at any time.
- Being tested
- Cefuroxime, Dicloxacillin, Cloxacillin, Amoxicillin/Clavulanic Acid, Microdialysis and serial blood sampling
- Keywords
- Microdialysis, Pharmacokinetics, Antibiotic tissue penetration, Inferior turbinate flap, Beta-lactam antibiotics, Tissue ischemia
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CefuroximeDrug
Sub-study 1: Cefuroxime 750 mg intravenously four times daily from day 1. On day 2, one dosing interval of cefuroxime 750 mg IV (sampled over 6 hours) followed by one dosing interval of cefuroxime 1500 mg IV (sampled over 8 hours), to compare tissue penetration of the two doses.
DicloxacillinDrug
Dicloxacillin 1000 mg orally. Sub-study 1: four times daily from day 1, with tissue and plasma sampling during the first dosing interval on day 2 (6 hours). Sub-study 2: three times daily postoperatively from day 1, with tissue and plasma sampling over one dosing interval after the morning dose on day 2.
CloxacillinDrug
Sub-study 1: Cloxacillin 1000 mg intravenously as a single dose in the second dosing interval on day 2 (given together with cefuroxime 1500 mg IV), with tissue and plasma sampling over 8 hours, to compare with oral dicloxacillin.
Amoxicillin/Clavulanic AcidDrug
Sub-study 2: Amoxicillin/clavulanic acid 500/125 mg orally three times daily postoperatively from day 1 (together with dicloxacillin), with tissue and plasma sampling of amoxicillin over one dosing interval after the morning dose on day 2.
Microdialysis and serial blood samplingProcedure or surgery
CE-marked microdialysis catheters perfused with isotonic saline (0.5-1 microL/min) are placed in the target tissues: infected and non-infected subcutaneous neck tissue (sub-study 1), or the inferior turbinate flap and nasal septal mucosa as reference tissue (sub-study 2). Dialysate is collected in 30-60 minute intervals, with serial blood samples drawn for plasma concentrations. Catheters are calibrated in vivo at the end of sampling and then removed.
| Study group | Role | What they receive |
|---|---|---|
| Sub-study 1: Postoperative Neck Infection | Experimental | Adults with a postoperative infection in the neck (n=8). Cefuroxime 750 mg IV four times daily and dicloxacillin 1000 mg orally four times daily from day 1. On day 2, microdialysis in infected and non-infected subcutaneous tissue over two consecutive dosing intervals: (1) cefuroxime 750 mg IV + dicloxacillin 1000 mg orally (6 hours); (2) cefuroxime 1500 mg IV + cloxacillin 1000 mg IV (8 hours), with serial plasma samples. Receives: Drug: Cefuroxime; Drug: Dicloxacillin; Drug: Cloxacillin; Procedure: Microdialysis and serial blood sampling |
| Sub-study 2: Inferior Turbinate Flap Reconstruction | Experimental | Adults undergoing reconstructive surgery with an inferior turbinate flap (n=8). Amoxicillin/clavulanic acid 500/125 mg and dicloxacillin 1000 mg orally three times daily postoperatively from day 1. Microdialysis in the flap and in nasal septal mucosa (reference tissue): ischemia markers and inflammatory proteins hourly for the first 6 postoperative hours and morning/evening on day 2; amoxicillin and dicloxacillin concentrations over one dosing interval after the morning dose on day 2, with serial plasma samples. Receives: Drug: Dicloxacillin; Drug: Amoxicillin/Clavulanic Acid; Procedure: Microdialysis and serial blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time Above the Minimal Inhibitory Concentration (T>MIC) in Tissue and Plasma
Time during which the free concentration of each study antibiotic (cefuroxime, cloxacillin, dicloxacillin, and amoxicillin/clavulanic acid) exceeds the minimal inhibitory concentration in each measured tissue (microdialysis) and in plasma (serial blood samples), calculated from concentration-time profiles. Pre-specified MIC targets: cefuroxime 4 mg/L; cloxacillin 2 mg/L; dicloxacillin 2 mg/L; amoxicillin/clavulanic acid 2 mg/L (amoxicillin component). Reported as time (hours) and as percentage of the dosing interval.
Measured: Sub-study 1: two consecutive dosing intervals on day 2 (0-6 hours and 0-8 hours after dosing). Sub-study 2: one dosing interval (approximately 8 hours) after the morning dose on postoperative day 2.
Secondary outcomes (8)
Area Under the Concentration-Time Curve (AUC) in Tissue and Plasma
AUC of the free concentration of each study antibiotic in each measured tissue compartment (microdialysis) and in plasma.
Measured: Sub-study 1: two consecutive dosing intervals on day 2 (0-6 hours and 0-8 hours after dosing). Sub-study 2: one dosing interval (approximately 8 hours) after the morning dose on postoperative day 2.
Tissue Penetration Ratio (AUC Tissue / AUC Plasma)
Ratio of the AUC of the free antibiotic concentration in each tissue compartment to the AUC in plasma, for each study antibiotic.
Measured: Sub-study 1: two consecutive dosing intervals on day 2 (0-6 hours and 0-8 hours after dosing). Sub-study 2: one dosing interval (approximately 8 hours) after the morning dose on postoperative day 2.
Maximum Concentration (Cmax) in Tissue and Plasma
Peak free concentration of each study antibiotic in each measured tissue compartment and in plasma.
Measured: Sub-study 1: two consecutive dosing intervals on day 2 (0-6 hours and 0-8 hours after dosing). Sub-study 2: one dosing interval (approximately 8 hours) after the morning dose on postoperative day 2.
Time to Maximum Concentration (Tmax) in Tissue and Plasma
Time from dose administration to peak free concentration of each study antibiotic in each measured tissue compartment and in plasma.
Measured: Sub-study 1: two consecutive dosing intervals on day 2 (0-6 hours and 0-8 hours after dosing). Sub-study 2: one dosing interval (approximately 8 hours) after the morning dose on postoperative day 2.
Elimination Half-Life (T1/2) in Tissue and Plasma
Elimination half-life of each study antibiotic in each measured tissue compartment and in plasma, derived from the concentration-time profiles.
Measured: Sub-study 1: two consecutive dosing intervals on day 2 (0-6 hours and 0-8 hours after dosing). Sub-study 2: one dosing interval (approximately 8 hours) after the morning dose on postoperative day 2.
Lactate/Pyruvate Ratio in the Inferior Turbinate Flap
Lactate/pyruvate ratio measured in microdialysate from the inferior turbinate flap and the nasal septal reference tissue, as a marker of tissue ischemia (sub-study 2).
Measured: Hourly during the first 6 postoperative hours (day 1), and in the morning and evening of postoperative day 2.
Tissue Ischemia Markers (Glucose, Lactate, Pyruvate, and Glycerol)
Concentrations of glucose, lactate, pyruvate, and glycerol in microdialysate from the measured tissue compartments.
Measured: Sub-study 2: hourly during the first 6 postoperative hours (day 1), and in the morning and evening of postoperative day 2. Sub-study 1: during the sampling period on day 2 (up to approximately 14 hours).
Inflammatory Proteins in Microdialysate
Levels of inflammatory proteins measured in microdialysate from the inferior turbinate flap and the nasal septal reference tissue, to characterize the early postoperative inflammatory tissue response (sub-study 2).
Measured: Hourly during the first 6 postoperative hours (day 1), and in the morning and evening of postoperative day 2.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Wound InfectionStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Two independent, non-randomized sub-studies in different patient populations: (1) patients with postoperative neck infection, and (2) patients undergoing reconstruction with an inferior turbinate flap. Within each sub-study, all participants receive the same protocol-defined antibiotic regimen, allowing within-patient comparison of tissue and plasma concentrations.
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tejs Ehlers Klug
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Cancer Society
- Responsible party
- Sponsor-investigator, Tejs Ehlers Klug, Aarhus University Hospital
- Investigators
- Tejs Ehlers Klug, MD, DMSc, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07896239
- Sponsor's protocol ID
- 2026-526995-22-00
- Other IDs
- 2026-526995-22-00
- Acronym
- ANTIBIOTIKA
- Status last verified
- Oct 2026
- First submitted
- 20 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared publicly due to Danish and EU data protection legislation (GDPR). Aggregated results will be published in peer-reviewed journals and reported in CTIS.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibiotic Penetration and Tissue Response in Infection and Reconstructive Surgery of the Head and Neck Region: A Microdialysis Study of Cefuroxime, Cloxacillin, Dicloxacillin, and Amoxicillin/Clavulanic Acid
- ClinicalTrials.gov ID
- NCT07896239
- Acronym / sponsor ID
- ANTIBIOTIKA / 2026-526995-22-00
- Keywords
- Microdialysis, Pharmacokinetics, Antibiotic tissue penetration, Inferior turbinate flap, Beta-lactam antibiotics, Tissue ischemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Tejs Ehlers KlugUniversity, hospital or other
- Collaborators
- Danish Cancer Society
- Study start
- Oct 2026 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 26 Oct 2026 (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.
The goal of this study is to measure how well commonly used antibiotics reach the tissue in the head and neck region in adults with a postoperative neck infection or undergoing reconstructive nasal surgery with an inferior turbinate flap. The study also describes markers of ischemia and inflammation in the newly created flap during the first days after surgery.
The main question it aims to answer is: For how long do the free concentrations of cefuroxime, cloxacillin, dicloxacillin, and amoxicillin/clavulanic acid stay above the minimal inhibitory concentration (T>MIC) in infected tissue, non-infected tissue, the flap, and plasma?
Participants will receive the antibiotics on a fixed, protocol-defined schedule for about two days. Small microdialysis catheters will be placed in the tissue to collect fluid continuously, and serial blood samples will be drawn. Participation ends when the last sample is collected and the catheters are removed.
Detailed description
Infections in the head and neck region and reconstructive surgery in the nasal and sinus area are associated with considerable morbidity and require effective antibiotic treatment. Treatment is based mainly on systemic antibiotic concentrations, but little is known about actual tissue penetration in infected tissue and in reconstructed flaps, where perfusion, edema, ischemia, and inflammation may alter drug distribution. Microdialysis is a minimally invasive method for continuous sampling of free, pharmacologically active drug concentrations and metabolic and inflammatory markers in the extracellular fluid.
This is a prospective, non-randomized, open-label, exploratory interventional study with two sub-studies and a total of 16 participants. All study drugs are marketed antibiotics used in routine clinical practice; they are administered in a protocol-defined regimen to allow pharmacokinetic sampling.
Sub-study 1 (n=8): Adults admitted with a postoperative infection in the neck. Treatment is started on day 1 with cefuroxime 750 mg IV four times daily and dicloxacillin 1000 mg orally four times daily. On day 2, microdialysis catheters are placed in infected and non-infected subcutaneous tissue of the neck, and sampling is performed over two consecutive dosing intervals: (1) cefuroxime 750 mg IV plus dicloxacillin 1000 mg orally, sampled for 6 hours; and (2) cefuroxime 1500 mg IV plus cloxacillin 1000 mg IV, sampled for 8 hours. This allows comparison of two cefuroxime doses and of oral dicloxacillin versus intravenous cloxacillin.
Sub-study 2 (n=8): Adults undergoing reconstructive surgery with an inferior turbinate flap (IFT flap). Postoperatively, amoxicillin/clavulanic acid 500/125 mg and dicloxacillin 1000 mg are given orally three times daily. Microdialysis catheters are placed in the flap and in the nasal septal mucosa (reference tissue). Ischemia markers (glucose, lactate, pyruvate, glycerol) and inflammatory proteins are sampled hourly during the first 6 postoperative hours and in the morning and evening of day 2. Antibiotic concentrations are measured over one dosing interval after the morning dose on day 2.
In both sub-studies, dialysate is collected in 30-60 minute intervals and serial blood samples are drawn for plasma concentrations. Catheters are calibrated in vivo at the end of sampling. Drug concentrations are analysed by LC-MS. Clinically indicated treatment can be changed by the treating physician at any time.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two independent, non-randomized sub-studies in different patient populations: (1) patients with postoperative neck infection, and (2) patients undergoing reconstruction with an inferior turbinate flap. Within each sub-study, all participants receive the same protocol-defined antibiotic regimen, allowing within-patient comparison of tissue and plasma concentrations.
| Arm | Type | Receives |
|---|---|---|
| Sub-study 1: Postoperative Neck Infection | Experimental | Drug: Cefuroxime, Drug: Dicloxacillin, Drug: Cloxacillin, Procedure: Microdialysis and serial blood samplingAdults with a postoperative infection in the neck (n=8). Cefuroxime 750 mg IV four times daily and dicloxacillin 1000 mg orally four times daily from day 1. On day 2, microdialysis in infected and non-infected subcutaneous tissue over two consecutive dosing intervals: (1) cefuroxime 750 mg IV + dicloxacillin 1000 mg orally (6 hours); (2) cefuroxime 1500 mg IV + cloxacillin 1000 mg IV (8 hours), with serial plasma samples. |
| Sub-study 2: Inferior Turbinate Flap Reconstruction | Experimental | Drug: Dicloxacillin, Drug: Amoxicillin/Clavulanic Acid, Procedure: Microdialysis and serial blood samplingAdults undergoing reconstructive surgery with an inferior turbinate flap (n=8). Amoxicillin/clavulanic acid 500/125 mg and dicloxacillin 1000 mg orally three times daily postoperatively from day 1. Microdialysis in the flap and in nasal septal mucosa (reference tissue): ischemia markers and inflammatory proteins hourly for the first 6 postoperative hours and morning/evening on day 2; amoxicillin and dicloxacillin concentrations over one dosing interval after the morning dose on day 2, with serial plasma samples. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Signed informed consent
- Either a postoperative infection in the neck (sub-study 1) or planned reconstruction with an inferior turbinate flap (sub-study 2)
- Age 18 years or older
Key exclusion criteria (3 listed)
- Known allergy or hypersensitivity to any of the study antibiotics (cefuroxime, cloxacillin, dicloxacillin, or amoxicillin/clavulanic acid)
- eGFR below 30 mL/min/1.73 m2
- Pregnancy or planned pregnancy
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 |
|---|---|---|
| CefuroximeSub-study 1: Cefuroxime 750 mg intravenously four times daily from day 1. On day 2, one dosing interval of cefuroxime 750 mg IV (sampled over 6 hours) followed by one dosing interval of cefuroxime 1500 mg IV (sampled over 8 hours), to compare tissue penetration of the two doses. | Drug | Sub-study 1: Postoperative Neck Infection |
| DicloxacillinDicloxacillin 1000 mg orally. Sub-study 1: four times daily from day 1, with tissue and plasma sampling during the first dosing interval on day 2 (6 hours). Sub-study 2: three times daily postoperatively from day 1, with tissue and plasma sampling over one dosing interval after the morning dose on day 2. | Drug | Sub-study 1: Postoperative Neck Infection, Sub-study 2: Inferior Turbinate Flap Reconstruction |
| CloxacillinSub-study 1: Cloxacillin 1000 mg intravenously as a single dose in the second dosing interval on day 2 (given together with cefuroxime 1500 mg IV), with tissue and plasma sampling over 8 hours, to compare with oral dicloxacillin. | Drug | Sub-study 1: Postoperative Neck Infection |
| Amoxicillin/Clavulanic AcidSub-study 2: Amoxicillin/clavulanic acid 500/125 mg orally three times daily postoperatively from day 1 (together with dicloxacillin), with tissue and plasma sampling of amoxicillin over one dosing interval after the morning dose on day 2. | Drug | Sub-study 2: Inferior Turbinate Flap Reconstruction |
| Microdialysis and serial blood samplingCE-marked microdialysis catheters perfused with isotonic saline (0.5-1 microL/min) are placed in the target tissues: infected and non-infected subcutaneous neck tissue (sub-study 1), or the inferior turbinate flap and nasal septal mucosa as reference tissue (sub-study 2). Dialysate is collected in 30-60 minute intervals, with serial blood samples drawn for plasma concentrations. Catheters are calibrated in vivo at the end of sampling and then removed. | Procedure or surgery | Sub-study 1: Postoperative Neck Infection, Sub-study 2: Inferior Turbinate Flap Reconstruction |
Primary outcome
Time Above the Minimal Inhibitory Concentration (T>MIC) in Tissue and Plasma
Time frame: Sub-study 1: two consecutive dosing intervals on day 2 (0-6 hours and 0-8 hours after dosing). Sub-study 2: one dosing interval (approximately 8 hours) after the morning dose on postoperative day 2.
Time during which the free concentration of each study antibiotic (cefuroxime, cloxacillin, dicloxacillin, and amoxicillin/clavulanic acid) exceeds the minimal inhibitory concentration in each measured tissue (microdialysis) and in plasma (serial blood samples), calculated from concentration-time profiles. Pre-specified MIC targets: cefuroxime 4 mg/L; cloxacillin 2 mg/L; dicloxacillin 2 mg/L; amoxicillin/clavulanic acid 2 mg/L (amoxicillin component). Reported as time (hours) and as percentage of the dosing interval.
8 secondary outcomes
Area Under the Concentration-Time Curve (AUC) in Tissue and Plasma
Time frame: Sub-study 1: two consecutive dosing intervals on day 2 (0-6 hours and 0-8 hours after dosing). Sub-study 2: one dosing interval (approximately 8 hours) after the morning dose on postoperative day 2.
Tissue Penetration Ratio (AUC Tissue / AUC Plasma)
Time frame: Sub-study 1: two consecutive dosing intervals on day 2 (0-6 hours and 0-8 hours after dosing). Sub-study 2: one dosing interval (approximately 8 hours) after the morning dose on postoperative day 2.
Maximum Concentration (Cmax) in Tissue and Plasma
Time frame: Sub-study 1: two consecutive dosing intervals on day 2 (0-6 hours and 0-8 hours after dosing). Sub-study 2: one dosing interval (approximately 8 hours) after the morning dose on postoperative day 2.
Time to Maximum Concentration (Tmax) in Tissue and Plasma
Time frame: Sub-study 1: two consecutive dosing intervals on day 2 (0-6 hours and 0-8 hours after dosing). Sub-study 2: one dosing interval (approximately 8 hours) after the morning dose on postoperative day 2.
Elimination Half-Life (T1/2) in Tissue and Plasma
Time frame: Sub-study 1: two consecutive dosing intervals on day 2 (0-6 hours and 0-8 hours after dosing). Sub-study 2: one dosing interval (approximately 8 hours) after the morning dose on postoperative day 2.
Lactate/Pyruvate Ratio in the Inferior Turbinate Flap
Time frame: Hourly during the first 6 postoperative hours (day 1), and in the morning and evening of postoperative day 2.
Tissue Ischemia Markers (Glucose, Lactate, Pyruvate, and Glycerol)
Time frame: Sub-study 2: hourly during the first 6 postoperative hours (day 1), and in the morning and evening of postoperative day 2. Sub-study 1: during the sampling period on day 2 (up to approximately 14 hours).
Inflammatory Proteins in Microdialysate
Time frame: Hourly during the first 6 postoperative hours (day 1), and in the morning and evening of postoperative day 2.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared publicly due to Danish and EU data protection legislation (GDPR). Aggregated results will be published in peer-reviewed journals and reported in CTIS.
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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.
Tejs Ehlers Klug, MD, DMSc principal investigator
Aarhus University Hospital
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 Cefuroxime, Dicloxacillin and Cloxacillin in people with Surgical Wound Infection and Neck Infection, run by Tejs Ehlers Klug at 1 site in Denmark.
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 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: opening soon, as of the sponsor's last update on 26 Oct 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 Denmark. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pelle Hanberg, MD, PhD (+45 28744852, pellehanberg@clin.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time Above the Minimal Inhibitory Concentration (T>MIC) in Tissue and Plasma (time frame: Sub-study 1: two consecutive dosing intervals on day 2 (0-6 hours and 0-8 hours after dosing). Sub-study 2: one dosing interval (approximately 8 hours) after the morning dose on postoperative day 2.). 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 26 Oct 2026.