Acute Otitis Media Clinical Trial
Official title:
Clinical Trial for the Assessment of Delayed Antibiotic Treatment in the Non-complicated Acute Respiratory Tract Infections in Pediatric (Study DAP-Pediatrics)
The general hypothesis is that delayed antibiotic treatment strategy present similar effectiveness, when compared with non-prescription of antibiotics or the prescription of antibiotics, in the non-complicated acute respiratory tract infections in pediatric patients.
The current project (DAP Pediatrics) is a study that explores the optimization of antibiotic
prescribing in our country by evaluating the delayed prescription of antibiotics. The
proposed trial will take place in the context of a prior similar study we conducted in
adults. The study currently underway is the DAP-Adults study (a randomised controlled trial
that evaluates several antibiotic prescribing strategies, including de delayed prescription
in uncomplicated acute respiratory infections in adults in primary care).
The aim of this study DAP-Pediatrics (randomized, multicenter parallel) to determine the
efficacy and safety of delayed prescription of antibiotics compared to direct prescription
and non-prescription of antibiotic in uncomplicated acute respiratory infections in pediatric
patients. This 3 arms clinical trial will include 450 children and will evaluate the duration
and severity of symptoms, antibiotic consumption, parents' satisfaction, the perceived
efficacy of antibiotics and the number of visits generated. The project also includes a
qualitative study, by means of structured interviews, to assess the perception and attitudes
of parents towards the different treatment strategies and carry out a full analysis of
economic evaluation.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02092454 -
Study to Assess the Safety and Efficacy of Benzocaine for Pain Relief in Children Presenting With Acute Otitis Media
|
Phase 2 | |
| Completed |
NCT01202578 -
Evaluation of the Tympanostomy Tube Delivery System
|
Phase 2/Phase 3 | |
| Withdrawn |
NCT00502450 -
Is There Hearing Loss After Acute Mastoiditis
|
N/A | |
| Completed |
NCT04296448 -
Evaluation of Cellphone Based Otoscopy in Pediatric Patients
|
N/A | |
| Terminated |
NCT05651633 -
Analgesic Ear Drops for Children With Acute Otitis Media
|
Phase 3 | |
| Completed |
NCT01941381 -
Does Tympanometry Predict Antibiotic Usage in Acute Otitis Media?
|
||
| Completed |
NCT02345447 -
Herbal-Based Medication vs. Placebo in Preventing Acute Otitis Media in Children at High Risk of Recurrence
|
Phase 3 | |
| Recruiting |
NCT01214538 -
Assessment of the Natural Antibody Response to Pneumococcal Surface Proteins During Acute Otitis Media in Children
|
N/A | |
| Completed |
NCT03614117 -
Effect of a New Probiotic Strain on Recurrent Acute Otitis Media in Children (PROMAR)
|
N/A | |
| Recruiting |
NCT06027593 -
Using Electronically Derived Automated Reports of Appropriate Antibiotic Use to Inform Stewardship Interventions
|
N/A | |
| Completed |
NCT02918773 -
Pediatric Emergency Department Smartphone Otoscope Study (PED-Oto)
|
N/A | |
| Completed |
NCT02567747 -
Vaccination Impact Against Pneumococcal Disease on Acute Otitis Media Morbidity in Colombian Children < 5 Years of Age
|
||
| Completed |
NCT02935374 -
Effect of Antimicrobial Treatment of Acute Otitis Media on the Intestinal Microbiome in Children
|
Phase 4 | |
| Completed |
NCT02567825 -
Efficacy of Tympanostomy Tubes for Children With Recurrent Acute Otitis Media
|
N/A | |
| Completed |
NCT02037893 -
Four Arm Safety & Efficacy With Antipyrine and Benzocaine Otic Solution in Children With Acute Otitis Media
|
Phase 2 | |
| Completed |
NCT00578773 -
A Phase II Study of an Otic Formulation in Treating Peri-Operative Tube Otorrhea
|
Phase 2 | |
| Completed |
NCT00377260 -
Acute Otitis Media (AOM) Therapy Trial in Young Children
|
Phase 4 | |
| Completed |
NCT00645112 -
A Comparison of Safety and Efficacy of Cefdinir Oral Suspension Versus Azithromycin in Pediatric Subjects With Acute Otitis Media
|
Phase 4 | |
| Completed |
NCT00368823 -
A Trial of Point of Care Information in Ambulatory Pediatrics
|
Phase 3 | |
| Completed |
NCT01272999 -
Impact of Prevnar 13 on Ear Infections in Children
|