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Leállítva3. fázis

AZithromycin Therapy in Preschoolers With a Severe Wheezing Episode Diagnosed at the Emergency Department

A legfontosabb adatok

Ki végzi
University of Arizona
Hol
Atlanta, Boston, Cincinnati, Dallas, Milwaukee, New York, Philadelphia és Pittsburgh (Egyesült Államok)Mind a 8 helyszín megnézése
Azonosító
Állapot
Leállítva
Fázis
3. fázis
Résztvevők
840 fő vett részt
Kezdés
2021. nov. 22.
Befejezés
2025. jan. 8.
A vizsgálat típusa
Beavatkozással járó, 2 csoportAz egyik csoport egy már használt kezelést kap, összehasonlításként.
A vizsgált kezelések
  • Azithromycin
  • Placebo
A regiszteradat frissítve
2026. június 23.
Miért állt le
The AZ-SWED trial was stopped by the National Heart, Lung, and Blood Institute (NHLBI) due to futility

Ki vehet részt

Életkor
18 hónap – 60 hónap
Nem
Nők és férfiak
Egészséges önkéntesek
Nem vehetnek részt

A regiszter feltételei, szó szerint

Mind a 18 feltétel megnézéseKevesebb

Ki vehet részt

  • Age 18 months to <60 months
  • The presence of expiratory wheezing as ascertained by a physician or nurse practitioner at admission to the ED
  • A Pediatric Respiratory Assessment Measurement (PRAM) score of greater than or equal to 4 at any time during the ED admission

Ki nem vehet részt

  • Current or previous use of systemic antibiotics within the last 2 weeks
  • Current or previous use of a steroid for wheezing within the last 2 weeks
  • Received oxygen for more than 5 days in the neonatal period, or received invasive mechanical ventilation
  • Participation in the evaluation of a drug or medical device currently or within the last 30 days
  • Previous enrollment into this trial
  • Presence of acute infection that requires systemic antibiotics, as determined by the physician
  • A known systemic illness (other than allergy) including but not limited to:; Recurrent seizures; Gastroesophageal reflux (GER) requiring medical treatment; Major congenital anomalies; Physical and intellectual delay; Cerebral palsy; A history of chest surgery; Tuberculosis or other chronic infections; Primary or secondary immunodeficiency; Gastrointestinal malformation or disease; Cardiac disorder (except for a hemodynamically insignificant atrial septal defect (ASD), ventricular septal defect (VSD) or benign heart murmur)
  • Significant developmental delay / failure to thrive, defined as a child plotting less than 3rd percentile
  • Any chronic lung disease
  • Known sensitivity or allergy to AZ
  • Positive PCR or antigen test for COVID-19 from hospital/doctor's office/testing center within the past 30 days
  • Born at less than 36 weeks estimated gestational age
  • Suspected foreign body induced aspiration during the last 2 weeks
  • The study intervention poses undue risk to patient in the opinion of the treating physician
  • Inability of the parent or guardian to speak English or Spanish

Helyszínek itt: Egyesült Államok

  • Children's Healthcare of Atlanta, Emory UniversityAtlanta, Egyesült ÁllamokNo longer taking part
  • Boston Children's HospitalBoston, Egyesült ÁllamokNo longer taking part
  • Cincinnati Children's Hospital Medical CenterCincinnati, Egyesült ÁllamokNo longer taking part
  • University of Texas Southwestern Medical CenterDallas, Egyesült ÁllamokNo longer taking part
  • The Medical College of WisconsinMilwaukee, Egyesült ÁllamokNo longer taking part
  • Children's Hospital of New York Medical CenterNew York, Egyesült ÁllamokNo longer taking part
  • The Children's Hospital of Philadelphia (CHOP)Philadelphia, Egyesült ÁllamokNo longer taking part
  • University of Pittsburgh Medical CenterPittsburgh, Egyesült ÁllamokNo longer taking part

A vizsgálatról

Mit akar kideríteni a vizsgálat

AZ-SWED is a parallel group, double blind, placebo control efficacy clinical trial with two separate hypotheses. The trial compared the 5-day outcome of preschool children presenting to an Emergency Department (ED) with an acute, severe wheezing episode and treated with either once daily oral Azithromycin (12 mg/kg/day for 5 days) or placebo. The AZ-SWED researchers made separate comparisons in children in whom specific pathogenic bacteria isolated from nasopharyngeal swabs, and in those in whom they were not isolated. The primary outcome was the Asthma Flare-up Diary for Young Children (ADYC), a validated instrument that caregivers will transmit electronically daily after discharge from the ED. Families were contacted daily during the five-day treatment to collect the ADYC, and to assess compliance and complications. A randomly chosen subset of enrolled children participated in two follow-up visits 5-8 days and 14-21 days after visit 1 to assess development of resistance to study drug and treatment response related changes in the airway microbiome.

A vizsgálat 2 csoportja

  • Treatment - ActiveMár használt kezelés, összehasonlításként

    Eligible participants were randomly assigned to the Azithromycin arm (1:1)

    Kezelés: Azithromycin

  • Treatment - PlaceboPlacebo, összehasonlításként

    Eligible patients were randomly assigned to the placebo arm, per the randomization schedule (1:1).

    Kezelés: Placebo

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
Hivatalos cím
AZithromycin Therapy in Preschoolers With a Severe Wheezing Episode Diagnosed at the Emergency Department (AZ-SWED)
Publikációk
A regiszteradat frissítve
2026. június 23.