NCT01363531

Clinical Trial for the Assessment of Delayed Antibiotic Treatment Strategies

Clinical Trial for the Assessment of Delayed Antibiotic Treatment Strategies in the Non-complicated Acute Respiratory Tract Infections in General Practice

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 405 (actual)
• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The general hypothesis is that delayed antibiotic treatment strategies present similar effectiveness, when compared with non-prescription of antibiotics or the prescription of antibiotics, in the non-complicated acute respiratory tract infections.

Detailed description

The aim of the PDA study is to assess the efficacy and safety of different delayed antibiotic prescribing strategies, compared to direct antibiotic treatment and no antibiotic treatment, for the treatment of non-complicated acute respiratory infections, in terms of symptoms duration and severity. Moreover, antibiotic consumption, patient satisfaction, efficacy perception and number of medical visits will be also assessed for each therapeutic strategy. The PDA is a multicentric study, parallel, randomised controlled trial to compare four antibiotic prescribing strategies in the non-complicated acute respiratory tract infections. The trial will include acute pharyngitis and/or acute tonsillitis, rhinosinusitis, acute bronchitis and acute exacerbation of chronic obstructive pulmonary disease with (mild to moderate) in adults. The expected number of patients to be included in this trial is 600. Therapeutic strategies include: direct antibiotic treatment, no antibiotic treatment, and two delayed antibiotic prescribing strategies (prescription given to patient with advice to use a course of antibiotics if needed in case of worsening of symptoms or not improving, and prescription left at the reception of the primary care center 3 days after the first medical visit). Follow-up period will be one month. The primary outcome will be symptom duration and severity. Other outcomes included will be use of antibiotics, patient satisfaction, perception of antibiotic efficacy, complications, and number of medical visits.

Conditions

• Pharyngitis
• Acute Tonsillitis
• Rhinosinusitis
• Acute Bronchitis
• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
OTHER	Antibiotic prescription strategies	The patients enrolled will be randomized between four treatment strategies or arms. Patients randomized to delayed treatment arms or direct treatment, doctors can choose the antibiotic that they consider appropriate depending on such local resistance or practice.

Timeline

• Start date: 2009-12-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2011-06-01
• Last updated: 2015-08-27

Locations

1 site across 1 country: Spain