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| Name | Class |
|---|---|
| Instituto de Salud Carlos III | OTHER_GOV |
| Ministry of Health, Spain | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Direct antibiotic treatment | Active Comparator | The doctor gives to parents an antibiotic prescription for their son's respiratory infection which he should start immediately. |
|
| No antibiotic treatment | No Intervention | The doctor does not give to parents an antibiotic prescription for their son's respiratory infection. | |
| Delayed antibiotic prescription | Experimental | The doctor gives to parents an antibiotic prescription for their son's respiratory infection with the advice to use it if needed, in case of worsening of symptoms or not improve. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antibiotic prescription strategies | Other | The patients enrolled will be randomized between three treatment strategies or arms. Patients randomized to delayed treatment arm or direct treatment, doctors can choose the antibiotic that they consider appropriate depending on such local resistance or practice. |
| Measure | Description | Time Frame |
|---|---|---|
| Duration and severity of symptoms | Coordination Centre performed telephone interviews. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Antibiotic consumption | Self-reported by the patients and checked at the Regional Pharmacy's Units. | 30 days |
| Parents satisfaction with treatment | Likert scale. |
| Measure | Description | Time Frame |
|---|---|---|
| Complications of disease | Included by doctors or coordination centre | 30 days |
General Inclusion Criteria:
In this study can be enrolled children (2 to 14 ages) with non-complicated acute respiratory tract infections, including pharyngotonsillitis, rhinosinusitis, acute bronchitis and acute media otitis. The doctors include children with these infections if they have reasonable doubts if they should treat with antibiotics.
General Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pablo Alonso Coello, PhD | Asociación Colaboración Cochrane Iberoamericana | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asociación Colaboración Cochrane Iberoamericana | Barcelona | 08041 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37784098 | Derived | Mas-Dalmau G, Perez-Lacasta MJ, Alonso-Coello P, Gorrotxategi-Gorrotxategi P, Arguelles-Prendes E, Espinazo-Ramos O, Valls-Duran T, Gonzalo-Alonso ME, Cortes-Viana MP, Menendez-Bada T, Vazquez-Fernandez ME, Perez-Hernandez AI, Munoz-Ortiz L, Villanueva-Lopez C, Little P, de la Poza-Abad M, Carles-Lavila M; DAP Paediatrics Group. A trial-based cost-effectiveness analysis of antibiotic prescription strategies for non-complicated respiratory tract infections in children. BMC Pediatr. 2023 Oct 2;23(1):497. doi: 10.1186/s12887-023-04235-3. |
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| ID | Term |
|---|---|
| D000096825 | Rhinosinusitis |
| D001991 | Bronchitis |
| D010033 | Otitis Media |
| D010549 | Personal Satisfaction |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D012852 | Sinusitis |
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Antibiotic treatment versus delayed antibiotic treatment
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|
| 30 days |
| Parents' belief in the efficacy of antibiotics | Likert scale | 30 days |
| Impact of DAP strategy on the reconsultation | Medical history review | 1 year |
| The prescription of antibiotics in the previous two years predicts the effect of prescribing strategies in reconsultation. | Medical history review | 1 year |
| D010254 |
| Paranasal Sinus Diseases |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D001982 | Bronchial Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D010031 | Otitis |
| D004427 | Ear Diseases |
| D001519 | Behavior |