Secondary Bacterial Infections and Nasal Colonization in Scabies and Atopic Dermatitis
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorIstanbul Medeniyet University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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).
Disqualifiers
Systemic or topical antibiotic use within the previous 14 days.
Active nasal infection or nasal symptoms.
History of nasal surgery or anatomic nasal deformity.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
51 Participants
are grouped into 3 trial groupsGroup A: Scabies with impetiginized lesions
Group B: Atopic dermatitis with impetiginized lesions
Group C: Healthy controls
Trial outcomes
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 enrollmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Istanbul Medeniyet University
Lead sponsor
Dr. Lutfi Kirdar Kartal Training and Research Hospital
Sponsor institution
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: