Safety of Discontinuing Patient Antibiotic Treatment (STOP-AB)

September 20, 2021 updated by: Carl Llor, Spanish Society of Family and Community Medicine

Safety of Discontinuing Patient Antibiotic Treatment When Physicians no Longer Consider it Necessary

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

430

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Balearic Islands
      • Palma de Mallorca, Balearic Islands, Spain, 07006
        • Coll d'en Rabassa Primary Health Center
    • Catalonia
      • Barcelona, Catalonia, Spain, 08015
        • Manso - Via Roma Primary Care Center
      • Barcelona, Catalonia, Spain, 08038
        • La Marina Primary Care Center
      • Barcelona, Catalonia, Spain, 08041
        • Guinardó Primary Care Center
      • Tarragona, Catalonia, Spain, 43005
        • Jaume I Primary Care Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Novel intervention group
Discontinuing antibiotic therapy.
Other: Discontinuing antibiotic therapy
Patients assigned to this group will be asked to discontinue antibiotic therapy.
Experimental: Usual intervention group
Usual strategy of continuing antibiotic treatment.
Other: Continuing antibiotic therapy
Patients assigned to this group will be asked to complete antibiotic therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From 14 to 28 days after the index visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From index visit to 28 days after the initial visit
Antibiotic consumption
Time Frame: From index visit to day 28
Any antibiotic taken by the patient
From index visit to day 28
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
Day 28 after the index visit
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
Day 28 after the index visit
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
Within the first 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spanish Society of Family and Community Medicine

Investigators

  • Study Director: Josep M Cots, Professor, University of Barcelona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2017

Primary Completion (Actual)

June 1, 2020

Study Completion (Actual)

December 1, 2020

Study Registration Dates

First Submitted

September 6, 2016

First Submitted That Met QC Criteria

September 9, 2016

First Posted (Estimate)

September 14, 2016

Study Record Updates

Last Update Posted (Actual)

September 21, 2021

Last Update Submitted That Met QC Criteria

September 20, 2021

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16/101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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