Status unknownNCT06170983AZI_IMQ_LPSUpdated Dec 14, 2023

Skin Inflammation and PK of Azithromycin

An interventional study of Azithromycin and Biopsy in Skin Infection, sponsored by Medical University of Vienna. Status unknown. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-14.

Sponsored by Medical University of Vienna · Not applicable, Interventional, and Basic science

The sponsor has not verified this record recently (last verified Dec 2023), so the status shown — last known as Not yet recruiting — may be out of date.

Phase: Not applicable
Study type: Interventional
Enrollment: 36
Allocation: Non-randomized
Ages: 18 Years to 55 Years
Sex: All

Study summary

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 studied

Skin Infection

Browse trials for

Cellulitis 151

In context

Cellulitis

151 studies on the registry are indexed under Cellulitis; 14 are open to participants now.

This study's planned enrollment of 36 is below the median of 151 across 121 interventional studies indexed under Cellulitis.

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Lead sponsor

Medical University of Vienna is the lead sponsor of 1,105 studies on the registry; 182 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 55 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

- 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)

Exclusion criteria

Exclusion Criteria:

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
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

Study design

Phase: Not applicable
Primary purpose: Basic science
Allocation: Non-randomized
Intervention model: Sequential assignment
Masking: None (open label)
Enrollment: 36 participants (estimated)

Study arms

Experimental
Pilot Cohort for Skin Inflammation
Testing skin inflammation
Diagnostic Test: Biopsy · Other: Skin inflammation model
Experimental
Azithromycin and Artificial Skin Inflammation
Investigating tissue PK of Azithromycin in artificially inflamed tissue
Drug: Azithromycin · Other: Skin inflammation model
Experimental
Azithromycin and Skin Infection
Investigating tissue PK of Azithromycin in actually infected tissue
Drug: Azithromycin

Interventions

DrugAzithromycin
500 mg once daily for 3 days
Diagnostic testBiopsy
Skin punch biopsy
OtherSkin inflammation model
LPS- or imiquimod induced skin inflammation

What researchers measure

Primary outcomes

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.
Time frame: Day 3
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.
Time frame: Day 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.
Time frame: Day 3
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.
Time frame: Day 3
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.
Time frame: Day 3
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.
Time frame: Day 3

Secondary outcomes

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
Time frame: Day 0-3
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
Time frame: Day 0-3

Study locations

No study locations are listed for this record.

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jan 2024; primary completion for Jan 2026, 24 months later.

Of 17 interventional studies with no phase under Cellulitis, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 28. This study's planned 24 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered: Nov 27, 2023
First posted: Dec 14, 2023
StartEst.: Jan 1, 2024
Primary completionEst.: Jan 1, 2026
CompletionEst.: Jul 1, 2026
Last update: Dec 14, 2023

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Dec 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06170983
Lead sponsor: Medical University of Vienna
Responsible party: Markus Zeitlinger (MD, Medical University of Vienna) — Principal investigator
First posted: Dec 14, 2023
Start date: Jan 1, 2024 (estimated)
Primary completion: Jan 1, 2026 (estimated)
Completion: Jul 1, 2026 (estimated)
Last update: Dec 14, 2023

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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