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Safety of Discontinuing Patient Antibiotic Treatment (STOP-AB)

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ClinicalTrials.gov Identifier: NCT02900820
Recruitment Status : Recruiting
First Posted : September 14, 2016
Last Update Posted : November 1, 2018
Sponsor:
Information provided by (Responsible Party):
Carl Llor, Spanish Society of Family and Community Medicine

Tracking Information
First Submitted Date  ICMJE September 6, 2016
First Posted Date  ICMJE September 14, 2016
Last Update Posted Date November 1, 2018
Study Start Date  ICMJE January 2017
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 9, 2016)
Duration of severe symptoms [ Time Frame: From 14 to 28 days after the index visit ]
Days with symptoms scoring 5 or 6 by means of a six-point Likert scale
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02900820 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2016)
  • Adverse effects of the medication [ Time Frame: From index visit to 28 days after the initial visit ]
    Any adverse effect appearing from day 0 to 28
  • Antibiotic consumption [ Time Frame: From index visit to day 28 ]
    Any antibiotic taken by the patient
  • Satisfaction with health care by means of a questionnaire [ Time Frame: Day 28 after the index visit ]
    Satisfaction degree stated by the patient at day 28
  • Belief in the effectiveness of antibiotic therapy by means of a questionnaire [ Time Frame: Day 28 after the index visit ]
    Degree of patient's belief in how effective antibiotics are for uncomplicated respiratory tract infections
  • Rate of complications [ Time Frame: Within the first 3 months ]
    Any complication related to the uncomplicated respiratory tract infection within the 3 first months after the index visit
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety of Discontinuing Patient Antibiotic Treatment
Official Title  ICMJE Safety of Discontinuing Patient Antibiotic Treatment When Physicians no Longer Consider it Necessary
Brief 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Infectious Diseases
  • Respiratory Tract Infections
Intervention  ICMJE
  • Other: Discontinuing antibiotic therapy
    Patients assigned to this group will be asked to discontinue antibiotic therapy.
  • Other: Continuing antibiotic therapy
    Patients assigned to this group will be asked to complete antibiotic therapy.
Study Arms  ICMJE
  • Experimental: Novel intervention group
    Discontinuing antibiotic therapy.
    Intervention: Other: Discontinuing antibiotic therapy
  • Experimental: Usual intervention group
    Usual strategy of continuing antibiotic treatment.
    Intervention: Other: Continuing antibiotic therapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 9, 2016)
430
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria: Patients with uncomplicated respiratory tract infections [common cold, influenza, pharyngitis, rhinosinusitis, acute bronchitis, and acute exacerbations of mild-to-moderate chronic obstructive pulmonary disease] who has previously taken any dose of antibiotic due to any of the following 3 clinical scenarios and accepts to participate in the clinical trial will be included:

  • Patients diagnosed with clinical conditions for which antibiotics are not necessary;
  • Patients diagnosed with a clinical condition for which antibiotics might be necessary but according to the history and clinical examination the primary health physician considers that antibiotics are not needed to be taken or the patients feel that the antibiotic regimen has not worked as expected and feel they need clinical reassessment
  • Patients who have taken some doses of an antibiotic (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

Exclusion Criteria:

  • Subjects under 18 and over 75 years of age
  • Patients with confirmed bacterial infection
  • Patients requiring hospital admission
  • Severe impairment of signs (impairment of consciousness, respiratory rate > 30 respirations per minute, heart rate > 125 beats per minute, systolic blood pressure < 90 mm Hg, diastolic blood pressure < 60 mm Hg, temperature > 40°C, oxygen saturation < 92%)
  • Problems to comply with treatment at home - sociopathy or psychiatric problems, drug or alcohol addiction, or within an inadequate family setting -
  • Lack of tolerance to oral treatment, such as the presence of nausea and vomiting, gastrectomy, post-surgery and/or diarrhoea
  • Significant comorbidity, including severe renal failure, hepatic cirrhosis, severe heart failure, immunosuppression - chronic HIV infection, transplantation, neutropenic, or patients receiving immunosuppressive drugs or corticosteroids -
  • Terminal disease
  • Admitted to a long-term residence
  • Difficulty to attend the programmed visits
  • Refusal to participate in the study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Carl Llor, GP 0034693696644 carles.llor@gmail.com
Contact: Eva Tudela, PhD 0034933170333 etudela@semfyc.es
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02900820
Other Study ID Numbers  ICMJE 16/101
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Carl Llor, Spanish Society of Family and Community Medicine
Study Sponsor  ICMJE Spanish Society of Family and Community Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Josep M Cots, Professor University of Barcelona
PRS Account Spanish Society of Family and Community Medicine
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP