NCT01800747

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2012

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 26, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 28, 2013

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 7, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 7, 2016

Completed
Last Updated

July 31, 2017

Status Verified

July 1, 2017

Enrollment Period

4 years

First QC Date

February 26, 2013

Last Update Submit

July 27, 2017

Conditions

RhinosinusitisAcute BronchitisAcute Otitis MediaPharyngotonsillitis

Keywords

Delayed antibiotic treatmentAcute respiratory infectionsPediatricsSatisfaction

Outcome Measures

Primary Outcomes (1)

  • Duration and severity of symptoms

    Coordination Centre performed telephone interviews.

    30 days

Secondary Outcomes (5)

  • Antibiotic consumption

    30 days

  • Parents satisfaction with treatment

    30 days

  • Parents' belief in the efficacy of antibiotics

    30 days

  • Impact of DAP strategy on the reconsultation

    1 year

  • The prescription of antibiotics in the previous two years predicts the effect of prescribing strategies in reconsultation.

    1 year

Other Outcomes (1)

  • Complications of disease

    30 days

Study Arms (3)

Direct antibiotic treatment

ACTIVE COMPARATOR

The doctor gives to parents an antibiotic prescription for their son's respiratory infection which he should start immediately.

Other: Antibiotic prescription strategies

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.

Other: Antibiotic prescription strategies

Interventions

Antibiotic prescription strategiesOTHER

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.

Delayed antibiotic prescriptionDirect antibiotic treatment

Eligibility Criteria

Age2 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients not aged between 2 and 14.
  • Patients have participated in the DAP-pediatrics previously.
  • Patients are severely affected or patients has been felt severely affected for one week (all time).
  • Patients with symptoms and signs suggestive of serious illness or severely affected and/or complications (particularly pneumonia, mastoiditis, peritonsillar abscess, peritonsillar cellulitis, intraorbital or intracranial complications).
  • Patients at high risk of serious complications due to prior comorbidity. This includes significant heart disease, lung, kidney, liver or neuromuscular, immunosuppression, cystic fibrosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asociación Colaboración Cochrane Iberoamericana

Barcelona, 08041, Spain

Location

Related Publications (1)

  • 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.

    PMID: 37784098DERIVED

MeSH Terms

Conditions

RhinosinusitisBronchitisOtitis MediaPersonal Satisfaction

Condition Hierarchy (Ancestors)

RhinitisRespiratory Tract InfectionsInfectionsSinusitisParanasal Sinus DiseasesNose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesBronchial DiseasesLung Diseases, ObstructiveLung DiseasesOtitisEar DiseasesBehavior

Study Officials

  • Pablo Alonso Coello, PhD

    Asociación Colaboración Cochrane Iberoamericana

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Antibiotic treatment versus delayed antibiotic treatment
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2013

First Posted

February 28, 2013

Study Start

June 1, 2012

Primary Completion

June 7, 2016

Study Completion

June 7, 2016

Last Updated

July 31, 2017

Record last verified: 2017-07

Locations

ES(1)