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Delayed antibiotic prescription for respiratory infections in children.

Clinical trial for the assessment of delayed antibiotic treatment in the non-complicated acute respiratory tract infections in pediatric. - DAP-pediatrics

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2011-005741-13-ES
Enrollment
Unknown
Registered
2011-12-12
Start date
2012-02-03
Completion date
Unknown
Last updated
2012-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uncomplicated respiratory tract infections in children.

Interventions

Product Name: Antibiotic Pharmaceutical Form: Tablet INN or Proposed INN: AMOXICILLIN CAS Number: 26787-78-0 Current Sponsor code: J01CA04 Other descriptive name: Amoxillin Concentration unit: mg/kg m

Sponsors

Asociación Colaboración Cochrane Iberoamericana
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: I) Children, up to 14 years, with uncomplicated respiratory infections: acute otitis media, rhinosinusitis, pharyngotonsillitis and acute bronchitis. II) To have reasonable doubts of the antibiotic prescription. Are the trial subjects under 18? yes Number of subjects for this age range: 450 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

Exclusion criteria

Exclusion criteria: I) Patients greater than or equal to 15 years of age. II) To be certain of the antibiotic prescription III) Pediatric patient with symptoms or signs suggestive of a serious condition and/or complications.

Design outcomes

Primary

MeasureTime frame
Main Objective: To investigate whether a delayed antibiotic prescription strategy compared with traditional antibiotic prescription or no antibiotic prescription leads to a similar duration in the severity of symptoms in children with uncomplicated respiratory tract infections.;Secondary Objective: Determinate the impact of the different treatment strategies/ Perceptions and attitudes about these treatment strategies/ The cost-effectiveness of the strategies/The number of additional medical visits/ The safety.;Primary end point(s): Duration and severity of symptoms;Timepoint(s) of evaluation of this end point: 30 days.—

Secondary

MeasureTime frame
Secondary end point(s): I) Antibiotic consumption II) Parents? satisfaction III) Parents' and pediatricians? belief in the efficacy of antibiotics IV) Perception of safety and efficacy V) Complications related to the infection process.;Timepoint(s) of evaluation of this end point: 30 days and after one year.—

Countries

Spain

Contacts

Public ContactPablo Alonso

Asociación Colaboración Cochrane Iberoamericana

palonso@santpau.cat0034935537808

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026