Authors
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Hospital Universitario Son Llàtzer -More
Category
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Primary study
Registry of Trials»EU Clinical Trials Register
Year
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2022
INTERVENTION: Trade Name: 1% aqueous chlorhexidine. Pharmaceutical Form: Concentrate for cutaneous spray, emulsion Trade Name: 2% fusidic acid cream Pharmaceutical Form: Cream CONDITION: Impetigo is a bacterial infection of very common skin in the pediatric population. In the usual clinical practice, the treatment of this infection has been based on topical antibiotics. The widespread use of antibiotics contributes to the increase of resistance. Focusing on the forms of localized impetigo, there are studies that suggest that treatment with topical antiseptics could be a good treatment option. Therapeutic area: Not possible to specify PRIMARY OUTCOME: Secondary Objective: ‐ Know the remission time of impetigo in the two treatment arms.; ‐ Know the percentage of impregites that evolve in each arm and specify another line of treatment.; ‐ Determine the causative bacterial agent of impestight with bad initial evolution.; ‐ Determine the cost‐effectiveness of treatment with topical antiseptic. Main Objective: Evaluate the efficacy of treatment with topical antiseptics versus topical antibiotherapy in the treatment of mild impétigo of pediatric age. Primary end point(s): the effectiveness of the treatment:; ‐ Response of injuries to treatment (0 Inadequate, 1 adequate); ‐ Evolution to serious forms (extensive lesions, staphylococcal scald ...); ‐ Adverse effects according to treatment (0 no, 1 yes); ‐ Requires entry (0 no, 1 Yes); ‐ Culture is collected (0 no, 1 Yes); ‐ Positive culture (0 no, 1 Yes); ‐ Causal agent (0 Staphylococcus, 1 Streptococcus, 2 others); ‐ Result antibiogram (determine the causative agent) Timepoint(s) of evaluation of this end point: the effectiveness of the treatment will be measured at 72 hours and subsequently at 7 days. SECONDARY OUTCOME: Timepoint(s) of evaluation of this end point: The demographic variables and the variables prior to treatment will be measured at the moment of inclusion of the patient, in the visit 0. Secondary end point(s): DEMOGRAPHIC VARIABLES:; ‐ Patient history number; ‐ Age (in months); ‐ Sex (0 female, 1 male); ‐ Person in charge of treatment at home (0 Mother, 1 Father, 2 both indistinctly, 3 another relative, own patient); ‐ History of atopy (0 No, 1 Yes); ‐ Drug allergies (0 No, 1 Yes); ‐ Other allergies (0 No, 1. Yes) ; ; VARIABLES PRIOR TO TREATMENT; ‐ Treatment that the patient will receive (0. Topical antibiotic ‐ odd days of the month; 1. Antiseptic ‐ Even days of the month).; ‐ Injury area (0.face, 1.legs, 2. Trunk); ‐ Initial injury (0 sting, 1 nonspecific injury, 2 do not remember that there was injury); ‐ Days of evolution of the lesions (in hours); ‐ Reconsultation for injuries (previously visit in health center or emergency room) (0 no, 1 Yes). INCLUSION CRITERIA: All patients who consult in the pediatric emergency service, who meet the following criteria: ‐ Age between 1 year and 13 years (inclusive). ‐ Patients diagnosed with localized non‐bullous impetigo. ‐ Not having received previous antibiotic treatment for the same episode. ‐ Parents / legal guardians who agree to participate in the study and sign the informed consent, after the relevant explanation of the study. Are the trial subjects under 18? yes Number of subjects for this age range: 40 F.1.2 Adults (18‐64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Epistemonikos ID: 66ada42143a2aeb9e0a4d674c02e1845fbfa452b
First added on: Aug 25, 2024