Safety of Discontinuing Patient Antibiotic Treatment
Condition: Infectious Diseases; Respiratory Tract Infections
MeSH terms: Infections; Communicable Diseases; Respiratory Tract Infections
Study type: Interventional

Summary: 
      There is no evidence that discontinuing antibiotic therapy for non-bacterial infections is
      safe. The main objective of this study is to determine whether discontinuation of antibiotic
      therapy when a clinician no longer considers it necessary makes any difference in terms of
      the number of days with severe symptoms. This is a multicentre, open-label, randomised
      controlled clinical trial. The study will be conducted in ten primary care centres in Spain.
      We will include patients from 18 to 75 years of age with uncomplicated acute respiratory
      tract infections (RTIs) in whom: antibiotics are not necessary; or those diagnosed with
      clinical conditions for which antibiotics might be necessary but according to the history and
      clinical examination the physician considers that antibiotics are not needed or the patient
      feels that the antibiotic regimen has not worked as expected; or several doses of an
      antibiotic have been taken from leftovers found in the household or obtained at the pharmacy
      without any medical prescription for a clinical condition for which antibiotics are not
      necessary. The patients will be randomly assigned to the usual strategy of continuing
      antibiotic treatment (usual intervention group) or discontinuing antibiotic therapy (novel
      intervention group). A sample size of 215 patients per group was calculated on the basis of a
      reduction of one day in the duration of severe symptoms as a clinically relevant outcome. The
      primary outcome will be duration of severe symptoms, i.e. symptoms scored 5 or 6 by means of
      a symptom diary. Secondary outcomes will include: antibiotics taken, adverse events, patient
      satisfaction, and complications within the first 3 months.
    

Detailed description: 
      Introduction: General practitioners (GP) have always been told to continue an antibiotic
      regimen once the patient has initiated it in order to prevent the patient from acquiring
      resistant microorganisms. This might be true for confirmed bacterial infections; however,
      continuing an antibiotic regimen when this is not indicated might hasten the acquisition of
      resistant organisms and cause adverse events. Since 2011 the Spanish Society of Family
      Medicine has been recommending GPs to ask their patients to stop taking antibiotics when they
      suspect a viral infection. However, there is no evidence that discontinuing antibiotic
      therapy for these conditions is safe. The main objective of this study is to determine
      whether discontinuation of antibiotic therapy when a GP no longer considers it necessary
      makes any difference in terms of the number of days with severe symptoms.

      Methods: This is a multicentre, open-label, randomised controlled clinical trial. The study
      will be conducted in ten primary care centres in Spain. We will include patients from 18 to
      75 years of age with uncomplicated acute respiratory tract infections (RTIs) in whom: 1.
      Antibiotics are not necessary; or 2. Those diagnosed with clinical conditions for which
      antibiotics might be necessary but according to the history and clinical examination the GP
      considers that antibiotics are not needed or the patient feels that the antibiotic regimen
      has not worked as expected; or 3. Several doses of an antibiotic have been taken from
      leftovers found in the household or obtained at the pharmacy without any medical prescription
      for a clinical condition for which antibiotics are not necessary. The patients will be
      randomly assigned to the usual strategy of continuing antibiotic treatment (usual
      intervention group) or discontinuing antibiotic therapy (novel intervention group). A sample
      size of 215 patients per group was calculated on the basis of a reduction of one day in the
      duration of severe symptoms as a clinically relevant outcome. The primary outcome will be
      duration of severe symptoms, i.e. symptoms scored 5 or 6 by means of a symptom diary.
      Secondary outcomes will include: antibiotics taken, adverse events, patient satisfaction, and
      complications within the first 3 months. A post-trial implementation observational clinical
      study by means of a qualitative analysis is planned to be carried out after the clinical
      trial to know the percentage of the use of the strategy of discontinuing antibiotic treatment
      and the pros and cons of its use.

      Ethics and dissemination: The study was approved by the Ethical Board of Fundació Jordi Gol i
      Gurina (reference number: 16/093) and informed consent will be obtained from all the patients
      included. The findings of this trial will be disseminated through research conferences and
      peer-reviewed journals.
    

Intervention name(s): Discontinuing antibiotic therapy; Continuing antibiotic therapy
Intervention type(s): Other; Other
Intervention description(s): Patients assigned to this group will be asked to discontinue antibiotic therapy.; Patients assigned to this group will be asked to complete antibiotic therapy.
Intervention MeSH terms: Anti-Bacterial Agents; Antibiotics, Antitubercular
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Anti-Bacterial Agents; Primary Health Care; Drug Resistance, Microbial; Respiratory Tract Infections