Ensayo clínico sobre la evaluación de las estrategias de tratamiento diferido con antibióticos en las infecciones respiratorias agudas no complicadas en atención primaria (Estudio PDA)

Phase 1

• Conditions: on-complicated acute respiratory infections

• Registration Number: EUCTR2009-011159-29-ES
• Lead Sponsor: Institut de Recerca de l?Hospital de la Santa Creu i Sant Pau

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-12
• Last Update Posted: 9 May 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

1) Adults > 18 years
2) Acute pharyngitis and/or acute tonsillitis,
3) Acute bronchitis,
4) Acute exacerbation of chronic bronchitis or chronic obstructive pulmonary disease with (mild to moderate),
5) Otitis media
6) To have doubts of the antibiotic prescription
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) To be certain of the antibiotic prescription
2) Acute exacerbation of chronic bronchitis or chronic obstructive pulmonary disease with (severe)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the efficacy (symptom duration and severity) of different delayed antibiotic prescribing strategies ,compared to direct antibiotic treatment and no antibiotic treatment, for the treatment of non-complicated acute respiratory infections.;Secondary Objective: Use of antibiotics, patient satisfaction, perception of antibiotic efficacy, complications, number of medical visits, and safety.;Primary end point(s): The primary outcome will be duration and severity of symptoms.