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Secondary Bacterial Infections and Nasal Colonization in Scabies and Atopic Dermatitis

10. september 2026 opdateret af: Tunç Ozen, Istanbul Medeniyet University

Microbiological Profile of Secondary Bacterial Infections and Nasal Colonization in Patients With Scabies and Atopic Dermatitis: A Prospective Observational Study

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Navn: TEST CONTACT - REPLACE
Telefonnummer: +90 000 000 0000
E-mail: test-contact@example.com

Studiesteder

Tyrkiet (Türkiye)
- - Istanbul, Tyrkiet (Türkiye)
    - Test Study Site - Replace

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

Barn
Voksen
Ældre voksen

Tager imod sunde frivillige

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Antal grupper/kohorter

Kohorter og interventioner

Gruppe / kohorte
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Concordance of bacterial species between impetiginized skin lesion and nasal cultures Tidsramme: At baseline (enrollment)	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)

Sekundære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Bacterial profile of impetiginized skin lesions Tidsramme: At baseline (enrollment)	The number and proportion of lesion cultures yielding Staphylococcus aureus, Streptococcus pyogenes, other bacteria, mixed growth, or no bacterial growth will be summarized.	At baseline (enrollment)
Nasal Staphylococcus aureus carriage across study groups Tidsramme: At baseline (enrollment)	The number and proportion of participants with nasal Staphylococcus aureus carriage will be summarized for the scabies, atopic dermatitis, and healthy control groups.	At baseline (enrollment)
Antimicrobial susceptibility and resistance profile of bacterial isolates Tidsramme: At baseline (enrollment)	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.	At baseline (enrollment)
Clinical response at day 14 Tidsramme: 14 days after enrollment	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.	14 days after enrollment
Development of new skin lesions during follow-up Tidsramme: Through 14 days after enrollment	The occurrence of new lesions during the 14-day follow-up period will be recorded.	Through 14 days after enrollment

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Istanbul Medeniyet University

Efterforskere

Ledende efterforsker: TEST INVESTIGATOR - REPLACE, TEST AFFILIATION - REPLACE

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. oktober 2026

Primær færdiggørelse (Anslået)

1. marts 2027

Studieafslutning (Anslået)

1. marts 2027

Datoer for studieregistrering

Først indsendt

4. september 2026

Først indsendt, der opfyldte QC-kriterier

4. september 2026

Først opslået (Faktiske)

10. september 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier