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Not yet recruitingNCT07813611Updated Sep 15, 2026

Secondary Bacterial Infections and Nasal Colonization in Scabies and Atopic Dermatitis

An observational study in Atopic Dermatitis (AD), Scabies and Impetigo, sponsored by Istanbul Medeniyet University. Not yet recruiting at 1 site in Turkey (Türkiye). Per ClinicalTrials.gov, last updated 2026-09-15.

Sponsored by Istanbul Medeniyet University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
51
Sex
All
01

Study summary

This prospective observational study will evaluate the microbiological profile of secondary bacterial infection and nasal colonization in participants with scabies or atopic dermatitis. Bacteria isolated from impetiginized skin lesions and nasal swabs will be compared, and antimicrobial susceptibility patterns will be assessed. Healthy participants without an inflammatory skin disease or signs of infection will provide nasal swabs as a control group. Patients will be followed on days 7 and 14 to assess clinical response and related clinical measures.

Read the detailed description

Participants with dermatologist-confirmed scabies or atopic dermatitis and active impetiginized skin lesions will undergo clinical assessment and microbiological sampling. A superficial swab will be obtained from the infected skin lesion and a nasal swab will be obtained from the nasal vestibules. Healthy controls will undergo nasal sampling only. Cultures will be evaluated for Staphylococcus aureus, Streptococcus pyogenes, and other bacterial isolates. Antimicrobial susceptibility testing will be performed according to European Committee on Antimicrobial Susceptibility Testing (EUCAST) guidance. Skin and nasal isolates will be compared at the species level and by antimicrobial resistance profile. Clinical data include age, sex, disease duration, comorbidities, recent treatments, itch severity using a 0-10 visual analog scale, and lesion morphology, location, number, and excoriation. Patients will be contacted on days 7 and 14 to assess clinical response, new lesion development, change in itch severity, treatment adherence, and local or systemic adverse events.

02

Conditions studied

  • Atopic Dermatitis (AD)
  • Scabies
  • Impetigo

Keywords

  • Staphylococcus aureus
  • Streptococcus pyogenes
  • Nasal colonization
  • Impetiginization
  • Antimicrobial resistance
  • MRSA
03

In context

Dermatitis, Atopic

1,591 studies on the registry are indexed under Dermatitis, Atopic; 286 are open to participants now.

This study's planned enrollment of 51 is below the median of 150 across 282 observational studies indexed under Dermatitis, Atopic.

Browse Dermatitis, Atopic studies →

Lead sponsor

Istanbul Medeniyet University is the lead sponsor of 192 studies on the registry; 17 are open to participants now.

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

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Participants presenting to a dermatology clinic will include patients with dermatologist-confirmed scabies or atopic dermatitis and active impetiginized skin lesions, as well as healthy controls without inflammatory skin disease or signs of infection.

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

  • Scabies group: dermatologist-confirmed scabies and an active impetiginized skin lesion.
  • Atopic dermatitis group: dermatologist-confirmed atopic dermatitis and an active impetiginized skin lesion.
  • Healthy control group: no inflammatory skin disease or clinical signs of infection.
  • Written (and appropriate parent/guardian permission when applicable).

Exclusion criteria

Exclusion Criteria:

  • Systemic or topical antibiotic use within the previous 14 days.
  • Active nasal infection or nasal symptoms.
  • History of nasal surgery or anatomic nasal deformity.

TEST DRAFT NOTE: The source protocol contains wording that may conflict with inclusion of healthy controls; the final eligibility text must be reconciled with the ethics-approved protocol before release.

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

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05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
51 participants (estimated)
Patient registry
No

Groups and cohorts

  • Scabies with impetiginized lesions

    Participants with dermatologist-confirmed scabies and an active impetiginized skin lesion suggestive of secondary bacterial infection.

  • Atopic dermatitis with impetiginized lesions

    Participants with dermatologist-confirmed atopic dermatitis and an active impetiginized skin lesion suggestive of secondary bacterial infection.

  • Healthy controls

    Participants without an inflammatory skin disease or clinical signs of infection; nasal swab sampling only.

06

What researchers measure

Primary outcomes

  1. Concordance of bacterial species between impetiginized skin lesion and nasal cultures

    Among participants in the scabies and atopic dermatitis groups with paired evaluable skin and nasal cultures, concordance will be defined as isolation of the same bacterial species from both anatomical sites. Species-level agreement will be summarized and evaluated using Cohen's kappa coefficient.

    Time frame: At baseline (enrollment)

Secondary outcomes

  1. Bacterial profile of impetiginized skin lesions

    The number and proportion of lesion cultures yielding Staphylococcus aureus, Streptococcus pyogenes, other bacteria, mixed growth, or no bacterial growth will be summarized.

    Time frame: At baseline (enrollment)

  2. Nasal Staphylococcus aureus carriage across study groups

    The number and proportion of participants with nasal Staphylococcus aureus carriage will be summarized for the scabies, atopic dermatitis, and healthy control groups.

    Time frame: At baseline (enrollment)

  3. Antimicrobial susceptibility and resistance profile of bacterial isolates

    Antimicrobial susceptibility results, including methicillin resistance among Staphylococcus aureus isolates and susceptibility to the antibiotics included in the laboratory panel, will be summarized for skin and nasal isolates.

    Time frame: At baseline (enrollment)

  4. Clinical response at day 14

    Clinical response will be categorized as complete remission, partial response, no change, or worsening. Associations with bacterial species, methicillin resistance, antimicrobial resistance, nasal carriage, and skin-nasal concordance will be explored.

    Time frame: 14 days after enrollment

  5. Development of new skin lesions during follow-up

    The occurrence of new lesions during the 14-day follow-up period will be recorded.

    Time frame: Through 14 days after enrollment

07

Study locations

1 site
  • Test Study Site - Replace
    Istanbul, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07813611
Responsible party
Tunç Ozen (Principal Investigator, Dr. Lutfi Kirdar Kartal Training and Research Hospital) — Principal investigator
First posted
Sep 10, 2026
Start date
Oct 2026 (estimated)
Primary completion
Mar 2027 (estimated)
Completion
Mar 2027 (estimated)
Last update
Sep 15, 2026

Study contacts

TEST CONTACT - REPLACE
Contact
test-contact@example.com
+90 000 000 0000
TEST INVESTIGATOR - REPLACE
principal investigator · TEST AFFILIATION - REPLACE

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 not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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