Delayed antibiotic prescription for respiratory infections in children.

• Register: EUCTR
• Last refreshed on: 26 June 2012
• Main ID: EUCTR2011-005741-13-ES
• Date of registration: 12/12/2011
• Prospective Registration: Yes
• Primary sponsor: Asociación Colaboración Cochrane Iberoamericana
• Public title: Delayed antibiotic prescription for respiratory infections in children.
• Scientific title: Clinical trial for the assessment of delayed antibiotic treatment in the non-complicated acute respiratory tract infections in pediatric. - DAP-pediatrics
• Date of first enrolment: 03/02/2012
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-005741-13
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: no antibiotics Number of treatment arms in the trial: 3

Countries of recruitment

Spain

Contacts

• Name: Pablo Alonso
• Affiliation: Asociación Colaboración Cochrane Iberoamericana

• Name: Pablo Alonso
• Affiliation: Asociación Colaboración Cochrane Iberoamericana

Key inclusion & exclusion 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:
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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Uncomplicated respiratory tract infections in children.

Intervention(s)

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 milligram(s)/kilogram
Concentration type: equal
Concentration number: 30-not applicable
INN or Proposed INN: PHENOXYMETHYLPENICILLIN
CAS Number: 87-08-1
Current Sponsor code: J01CE02
Other descriptive name: PHENOXYMETHYLPENICILLIN
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 250-

Primary Outcome(s)

Primary end point(s): Duration and severity of symptoms

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.

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.

Timepoint(s) of evaluation of this end point: 30 days.

Secondary Outcome(s)

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.

Secondary ID(s)

PDA-pediatría

Source(s) of Monetary Support

Instituto de Salud Carlos III