Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Clinical Trial for the Assessment of Delayed Antibiotic Treatment Strategies in the Non-complicated Acute Respiratory Tract Infections in General Practice
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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