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Skin InfectionAZI_IMQ_LPSNCT06170983

Skin Inflammation and PK of Azithromycin

A study testing Azithromycin, Biopsy and Skin inflammation model in people with Skin Infection, run by Medical University of Vienna.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study will investigate the tissue distribution of azithromycin in healthy, artificially inflamed and actually infected tissue of humans. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Skin Infection
What is being tested?
Azithromycin, Biopsy and Skin inflammation model
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
No sites listed yet
Study dates
1 Jan 2024to 1 Jul 2026
Phase
Interventional
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 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • • Men and women aged ≥18 and <55 years
  • BMI ≥18 and ≤30 kg/m2
  • Normal (or clinically irrelevant abnormal) findings in medical history and physical examination
  • Women with child-bearing potential: use of effective contraception
  • Laboratory parameters within the given reference range (or abnormal findings which are irrelevant for study purposes in the Investigator's opinion)

Who cannot join

  • Known or suspected allergy to lipopolysaccharide, imiquimod, or sticking plasters
  • Only Part 0c: Known or suspected allergy to local anesthetics
  • History of severe allergic or anaphylactic reactions to any medication • Blood donation within the last 4 weeks before the study
  • Treatment with an investigational drug within three weeks before the study
  • Smoking of more than 5 cigarettes per day
  • Regular use of medication or abuse of alcohol
Show all 12Show fewer
  • Use of any medication within one week before the study
  • Symptoms of a clinically relevant illness in the 3 months before the study
  • Liver or kidney dysfunction
  • Pregnancy
  • History of autoimmune diseases (especially psoriasis)
  • Other objections to participating in the study in the opinion of the Investigator

About this study

Official title: Validation of Imiquimod- and LPS-induced Skin Inflammation Models and Their Application in the Investigation of Azithromycin Concentration in Inflamed, Infected, and Healthy Subcutaneous Tissue

This study will investigate the tissue distribution of azithromycin in healthy, artificially inflamed and actually infected tissue of humans.

Read the detailed description

This single-center, prospective, open-label, adaptive, pharmacokinetic study will comprise three parts: Part 0a-c, Part A, and Part B.

Objectives: This study primarily aims to characterize and establish a new skin inflammation model using topically applied LPS. The secondary aim of this research is to deepen our understanding of the role of leukocytes as potential transport vehicles for macrolides and other antibiotics in humans.

Intervention: Part 0 will serve as a pilot experiment in healthy volunteers to validate the imiquimod and LPS challenge in a controlled design. The investigators will clinically assess the tolerability of increasing LPS doses and the already published design of the imiquimod challenge. In general, the investigators will perform the different designs of skin inflammation models using tape stripping and an occlusive 18-mm Finn chamber.

The inflammation will not only be clinically assessed but also objectively quantified using the imaging-based mobile phone application Scarletred®Vision. Considering these results, the investigators will again carry out the LPS and imiquimod challenge in healthy volunteers and additionally perform biopsies in Part 0c to collect specimens for flow cytometry. Thus, the investigators will be able to characterize the skin inflammation models at a cellular level. Using NGS, the investigators will also explore transcriptional changes within cell subset that are affected by the inflammation.

In Part 0c, the investigators will include 12 healthy volunteers and will perform in each subject three skin punch biopsies, including a negative control, IMQ-challenged skin and LPS-challenged skin. Using flow cytometry, the investigators will measure the infiltration of leukocytes subsets.

Part A will employ a skin inflammation challenge based on either LPS or the imiquimod according to the results of Part 0 (i.e., the one showing the greater leucocyte infiltration). Azithromycin will be given in parallel once daily for 3 consecutive days. After the last application (i.e. day 3), two microdialysis probes will be placed in the inflamed subcutaneous tissue and one will be placed in the unmanipulated healthy subcutaneous fat. Hereafter, PK sampling and microdialysis of two thighs will be performed for two consecutive days. The investigators will isolate leukocytes from blood samples on day 3 to determine the average concentration of azithromycin in them. Biopsies from the unmanipulated and the challenged skin will be obtained on day 4.

Part B will involve patients with skin infections including erysipelas and cellulitis at their lower extremities. In contrast to Part A, only one microdialysis probe will be placed into the infected subcutaneous tissue and one into healthy, unaffected tissue. After three doses of azithromycin, pharmacokinetic sampling, leukocyte isolation, and microdialysis of the healthy thigh and the respective area of infection will be performed.

Conditions
Skin Infection
Being tested
Azithromycin, Biopsy, Skin inflammation model
Medical subject headings
Cellulitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AzithromycinDrug

    500 mg once daily for 3 days

  • BiopsyDiagnostic test

    Skin punch biopsy

  • Skin inflammation modelOther

    LPS- or imiquimod induced skin inflammation

Study groups in NCT06170983
Study groupRoleWhat they receive
Pilot Cohort for Skin InflammationExperimentalTesting skin inflammation
Receives: Diagnostic Test: Biopsy; Other: Skin inflammation model
Azithromycin and Artificial Skin InflammationExperimentalInvestigating tissue PK of Azithromycin in artificially inflamed tissue
Receives: Drug: Azithromycin; Other: Skin inflammation model
Azithromycin and Skin InfectionExperimentalInvestigating tissue PK of Azithromycin in actually infected tissue
Receives: Drug: Azithromycin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 0: Area under the curve (AUC) of azithromycin in artificially inflamed tissue

    The pharmacokinetic concentration-time profile in tissue will be assessed by microdialysis. Concentration-time profiles will be plotted. AUC and Cmax will be used as PK parameters.

    Measured: Day 3

  2. Part 0: Maximum concentration (Cmax) of azithromycin in artificially inflamed tissue

    The pharmacokinetic concentration-time profile in tissue will be assessed by microdialysis. Concentration-time profiles will be plotted. AUC and Cmax will be used as PK parameters.

    Measured: Day 3

  3. Part A: Area under the curve (AUC) Azithromycin in healthy and inflamed tissue

    The pharmacokinetic concentration-time profile in tissue will be assessed by microdialysis. Concentration-time profiles will be plotted. AUC and Cmax will be used as PK parameters.

    Measured: Day 3

  4. Part A: Maximum concentration (Cmax) Azithromycin in healthy and inflamed tissue

    The pharmacokinetic concentration-time profile in tissue will be assessed by microdialysis. Concentration-time profiles will be plotted. AUC and Cmax will be used as PK parameters.

    Measured: Day 3

  5. Part B: Area under the curve (AUC) of Azithromycin in healthy and infected tissue

    The pharmacokinetic concentration-time profile in tissue will be assessed by microdialysis. Concentration-time profiles will be plotted. AUC and Cmax will be used as PK parameters.

    Measured: Day 3

  6. Part B: Maximum concentration (Cmax) of Azithromycin in healthy and infected tissue

    The pharmacokinetic concentration-time profile in tissue will be assessed by microdialysis. Concentration-time profiles will be plotted. AUC and Cmax will be used as PK parameters.

    Measured: Day 3

Secondary outcomes (2)

  1. Part 0-A: Safety and tolerability of inflammation models

    Data will be aggregated as:

    • number of participants with treatment-related local adverse events due to the inflammation models
    • number of participants with treatment-related systemic adverse events due to the inflammation models

    Measured: Day 0-3

  2. Part A-B: Safety and tolerability of azithromycin

    Data will be presented as:

    • number of participants with treatment-related systemic adverse events due to azithromycin
    • mean number of treatment-related systemic adverse events due to azithromycin per subject

    Measured: Day 0-3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Dec 2023
  2. Study start1 Jan 2024 (estimated)
  3. Primary completion1 Jan 2026 (estimated)
  4. Study completion1 Jul 2026 (estimated)

Resources

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 N/A
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06170983
Sponsor's protocol ID
Pro_AZI_IMQ_LPS
Acronym
AZI_IMQ_LPS
Status last verified
Dec 2023
First submitted
27 Nov 2023
Last updated
14 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Azithromycin, Biopsy and Skin inflammation model in people with Skin Infection, run by Medical University of Vienna.

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 5 inclusion and 12 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 14 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

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?

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?

Part 0: Area under the curve (AUC) of azithromycin in artificially inflamed tissue (time frame: Day 3). The study lists 6 primary outcomes in all. 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 NCT06170983.

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 14 Dec 2023.

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