Infectious DiseasesSTOP-ABNCT02900820
Safety of Discontinuing Patient Antibiotic Treatment
A study testing Discontinuing antibiotic therapy and Continuing antibiotic therapy in people with Infectious Diseases and Respiratory Tract Infections, run by Spanish Society of Family and Community Medicine at 5 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Infectious Diseases, Respiratory Tract Infections
- What is being tested?
- Discontinuing antibiotic therapy and Continuing antibiotic therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 430 participants
- Where
- 5 sitesSpain
- Study dates
- Jan 2017to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Spain5 sites
Manso - Via Roma Primary Care Center
Barcelona, Catalonia, 08015
La Marina Primary Care Center
Barcelona, Catalonia, 08038
Guinardó Primary Care Center
Barcelona, Catalonia, 08041
Coll d'en Rabassa Primary Health Center
Palma de Mallorca, Balearic Islands, 07006
Jaume I Primary Care Center
Tarragona, Catalonia, 43005
About this study
Official title: 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.
Read the 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.
- Conditions
- Infectious Diseases, Respiratory Tract Infections
- Being tested
- Discontinuing antibiotic therapy, Continuing antibiotic therapy
- Keywords
- Anti-Bacterial Agents, Primary Health Care, Drug Resistance, Microbial, Respiratory Tract Infections
- Medical subject headings
- Communicable Diseases, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Discontinuing antibiotic therapyOther
Patients assigned to this group will be asked to discontinue antibiotic therapy.
Continuing antibiotic therapyOther
Patients assigned to this group will be asked to complete antibiotic therapy.
| Study group | Role | What they receive |
|---|---|---|
| Novel intervention group | Experimental | Discontinuing antibiotic therapy. Receives: Other: Discontinuing antibiotic therapy |
| Usual intervention group | Experimental | Usual strategy of continuing antibiotic treatment. Receives: Other: Continuing antibiotic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of severe symptoms
Days with symptoms scoring 5 or 6 by means of a six-point Likert scale
Measured: From 14 to 28 days after the index visit
Secondary outcomes (5)
Adverse effects of the medication
Any adverse effect appearing from day 0 to 28
Measured: From index visit to 28 days after the initial visit
Antibiotic consumption
Any antibiotic taken by the patient
Measured: From index visit to day 28
Satisfaction with health care by means of a questionnaire
Satisfaction degree stated by the patient at day 28
Measured: Day 28 after the index visit
Belief in the effectiveness of antibiotic therapy by means of a questionnaire
Degree of patient's belief in how effective antibiotics are for uncomplicated respiratory tract infections
Measured: Day 28 after the index visit
Rate of complications
Any complication related to the uncomplicated respiratory tract infection within the 3 first months after the index visit
Measured: Within the first 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2016 (estimated)
- Study startJan 2017
- Primary completionJun 2020
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Infectious DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 430 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spanish Society of Family and Community Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carl Llor, Spanish Society of Family and Community Medicine
- Investigators
- Josep M Cots, Professor, Study director, University of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02900820
- Sponsor's protocol ID
- 16/101
- Acronym
- STOP-AB
- Status last verified
- Oct 2020
- First submitted
- 6 Sep 2016
- Last updated
- 21 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Gilbert GL. Knowing when to stop antibiotic therapy. Med J Aust. 2015 Feb 16;202(3):121-2. doi: 10.5694/mja14.01201. No abstract available.
PubMed 25669463Costelloe C, Metcalfe C, Lovering A, Mant D, Hay AD. Effect of antibiotic prescribing in primary care on antimicrobial resistance in individual patients: systematic review and meta-analysis. BMJ. 2010 May 18;340:c2096. doi: 10.1136/bmj.c2096.
PubMed 20483949Dekker AR, Verheij TJ, van der Velden AW. Inappropriate antibiotic prescription for respiratory tract indications: most prominent in adult patients. Fam Pract. 2015 Aug;32(4):401-7. doi: 10.1093/fampra/cmv019. Epub 2015 Apr 24.
PubMed 25911505Morgan DJ, Okeke IN, Laxminarayan R, Perencevich EN, Weisenberg S. Non-prescription antimicrobial use worldwide: a systematic review. Lancet Infect Dis. 2011 Sep;11(9):692-701. doi: 10.1016/S1473-3099(11)70054-8. Epub 2011 Jun 12.
PubMed 21659004Goossens H, Ferech M, Vander Stichele R, Elseviers M; ESAC Project Group. Outpatient antibiotic use in Europe and association with resistance: a cross-national database study. Lancet. 2005 Feb 12-18;365(9459):579-87. doi: 10.1016/S0140-6736(05)17907-0.
PubMed 15708101Llor C, Moragas A, Bayona C, Cots JM, Hernandez S, Calvino O, Rodriguez M, Miravitlles M. Efficacy and safety of discontinuing antibiotic treatment for uncomplicated respiratory tract infections when deemed unnecessary. A multicentre, randomized clinical trial in primary care. Clin Microbiol Infect. 2022 Feb;28(2):241-247. doi: 10.1016/j.cmi.2021.07.035. Epub 2021 Aug 4.
PubMed 34363942Llor C, Moragas A, Bayona C, Cots JM, Molero JM, Ribas J, Fothy JF, Gutierrez I, Sanchez C, Ortega J, Arranz J, Botanes J, Robles P. The STOP-AB trial protocol: efficacy and safety of discontinuing patient antibiotic treatment when physicians no longer consider it necessary. BMJ Open. 2017 Jun 6;7(5):e015814. doi: 10.1136/bmjopen-2016-015814.
PubMed 28592581
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Discontinuing Patient Antibiotic Treatment When Physicians no Longer Consider it Necessary
- ClinicalTrials.gov ID
- NCT02900820
- Acronym / sponsor ID
- STOP-AB / 16/101
- Conditions
- Infectious Diseases, Respiratory Tract Infections
- Keywords
- Anti-Bacterial Agents, Primary Health Care, Drug Resistance, Microbial, Respiratory Tract Infections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 430 participants (actual)
- Lead sponsor
- Spanish Society of Family and Community MedicineUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Jun 2020 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 14 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Novel intervention group | Experimental | Other: Discontinuing antibiotic therapyDiscontinuing antibiotic therapy. |
| Usual intervention group | Experimental | Other: Continuing antibiotic therapyUsual strategy of continuing antibiotic treatment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (11 listed)
- 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 -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Discontinuing antibiotic therapyPatients assigned to this group will be asked to discontinue antibiotic therapy. | Other | Novel intervention group |
| Continuing antibiotic therapyPatients assigned to this group will be asked to complete antibiotic therapy. | Other | Usual intervention group |
Primary outcome
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
5 secondary outcomes
Adverse effects of the medication
Time frame: From index visit to 28 days after the initial visit
Antibiotic consumption
Time frame: From index visit to day 28
Satisfaction with health care by means of a questionnaire
Time frame: 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
Rate of complications
Time frame: Within the first 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2021.
- Background: PubMed 25669463Gilbert GL. Knowing when to stop antibiotic therapy. Med J Aust. 2015 Feb 16;202(3):121-2. doi: 10.5694/mja14.01201. No abstract available.
- Background: PubMed 20483949Costelloe C, Metcalfe C, Lovering A, Mant D, Hay AD. Effect of antibiotic prescribing in primary care on antimicrobial resistance in individual patients: systematic review and meta-analysis. BMJ. 2010 May 18;340:c2096. doi: 10.1136/bmj.c2096.
- Background: PubMed 25911505Dekker AR, Verheij TJ, van der Velden AW. Inappropriate antibiotic prescription for respiratory tract indications: most prominent in adult patients. Fam Pract. 2015 Aug;32(4):401-7. doi: 10.1093/fampra/cmv019. Epub 2015 Apr 24.
- Background: PubMed 21659004Morgan DJ, Okeke IN, Laxminarayan R, Perencevich EN, Weisenberg S. Non-prescription antimicrobial use worldwide: a systematic review. Lancet Infect Dis. 2011 Sep;11(9):692-701. doi: 10.1016/S1473-3099(11)70054-8. Epub 2011 Jun 12.
- Background: PubMed 15708101Goossens H, Ferech M, Vander Stichele R, Elseviers M; ESAC Project Group. Outpatient antibiotic use in Europe and association with resistance: a cross-national database study. Lancet. 2005 Feb 12-18;365(9459):579-87. doi: 10.1016/S0140-6736(05)17907-0.
- Derived from this study: PubMed 34363942Llor C, Moragas A, Bayona C, Cots JM, Hernandez S, Calvino O, Rodriguez M, Miravitlles M. Efficacy and safety of discontinuing antibiotic treatment for uncomplicated respiratory tract infections when deemed unnecessary. A multicentre, randomized clinical trial in primary care. Clin Microbiol Infect. 2022 Feb;28(2):241-247. doi: 10.1016/j.cmi.2021.07.035. Epub 2021 Aug 4.
- Derived from this study: PubMed 28592581Llor C, Moragas A, Bayona C, Cots JM, Molero JM, Ribas J, Fothy JF, Gutierrez I, Sanchez C, Ortega J, Arranz J, Botanes J, Robles P. The STOP-AB trial protocol: efficacy and safety of discontinuing patient antibiotic treatment when physicians no longer consider it necessary. BMJ Open. 2017 Jun 6;7(5):e015814. doi: 10.1136/bmjopen-2016-015814.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Josep M Cots, Professor study director
University of Barcelona
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Discontinuing antibiotic therapy and Continuing antibiotic therapy in people with Infectious Diseases and Respiratory Tract Infections, run by Spanish Society of Family and Community Medicine at 5 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of severe symptoms (time frame: From 14 to 28 days after the index visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02900820, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2021.