Secondary Bacterial Infections and Nasal Colonization in Scabies and Atopic Dermatitis

NCT07813611 | Not Yet Recruiting

• 1 other identifier: SCAB-AD-NASAL-TEST-001
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atopic Dermatitis (AD); Impetigo; Scabies

Keywords

Staphylococcus aureus; Streptococcus pyogenes; Nasal colonization; Impetiginization; Antimicrobial resistance; MRSA

Outcome Measures

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.

  At baseline (enrollment)

Secondary Outcomes (5)

• Bacterial profile of impetiginized skin lesions

  At baseline (enrollment)

• Nasal Staphylococcus aureus carriage across study groups

  At baseline (enrollment)

• Antimicrobial susceptibility and resistance profile of bacterial isolates

  At baseline (enrollment)

• Clinical response at day 14

  14 days after enrollment

• Development of new skin lesions during follow-up

  Through 14 days after enrollment

Study Arms (3)

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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 informed consent (and appropriate parent/guardian permission when applicable).

You may not qualify if:

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

Sponsors & Collaborators

• Istanbul Medeniyet University: lead

Study Sites (1)

Test Study Site - Replace

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Scabies; Impetigo; Staphylococcal Infections

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Mite Infestations; Ectoparasitic Infestations; Skin Diseases, Parasitic; Parasitic Diseases; Infections; Skin Diseases, Infectious; Staphylococcal Skin Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Skin Diseases, Bacterial

Study Officials

• TEST INVESTIGATOR - REPLACE

  TEST AFFILIATION - REPLACE

  PRINCIPAL INVESTIGATOR

Central Study Contacts

TEST CONTACT - REPLACE

CONTACT

+90 000 000 0000; test-contact@example.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 4, 2026
• First Posted: September 10, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: September 15, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)