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)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-011159-29-ES

Enrollment

600

Registered

2009-03-12

Start date

2009-06-23

Completion date

Unknown

Last updated

2016-05-09

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

Conditions

Non-complicated acute respiratory infections

Interventions

Product Name: Antibiotic Pharmaceutical Form: Tablet INN or Proposed INN: PHENOXYMETHYLPENICILLIN CAS Number: 87081 Concentration unit: mg milligram(s) Concentration type: equal Concentration number:

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Spain

Outcome results

None listed

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