Test Study Site - Replace
Istanbul, Turkey (Türkiye)
NCT Number: NCT07813611
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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Observational
Istanbul, Turkey (Türkiye)
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
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.
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.
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.
Time frame: Through 14 days after enrollment
The occurrence of new lesions during the 14-day follow-up period will be recorded.
Contact information is provided by the study sponsor or research team.
Istanbul Medeniyet University
Other
Microbiological Profile of Secondary Bacterial Infections and Nasal Colonization in Patients With Scabies and Atopic Dermatitis: A Prospective Observational Study
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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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