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NCT Number: NCT07813611

Secondary Bacterial Infections and Nasal Colonization in Scabies and Atopic Dermatitis

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

    Time frame: 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.

Secondary outcomes

  1. Bacterial profile of impetiginized skin lesions

    Time frame: 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.

  2. Nasal Staphylococcus aureus carriage across study groups

    Time frame: 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.

  3. Antimicrobial susceptibility and resistance profile of bacterial isolates

    Time frame: 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.

  4. Clinical response at day 14

    Time frame: 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.

  5. Change in itch severity from baseline to follow-up

    Time frame: Baseline, day 7, and day 14

    Itch severity will be measured using a 0-10 visual analog scale. Change from baseline will be summarized at day 7 and day 14.

  6. Development of new skin lesions during follow-up

    Time frame: Through 14 days after enrollment

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

Study contacts

Contact information is provided by the study sponsor or research team.

TEST CONTACT - REPLACE

CONTACT

[email protected]

+90 000 000 0000

Sponsors and collaborators

Lead sponsor

Istanbul Medeniyet University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 10, 2026
Registry last updated
Sep 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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