Safety of Discontinuing Patient Antibiotic Treatment (STOP-AB)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02900820 |
|
Recruitment Status :
Recruiting
First Posted : September 14, 2016
Last Update Posted : November 1, 2018
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Infectious Diseases Respiratory Tract Infections | Other: Discontinuing antibiotic therapy Other: Continuing antibiotic therapy | Not Applicable |
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 (Clinical Trial) |
| Estimated Enrollment : | 430 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Safety of Discontinuing Patient Antibiotic Treatment When Physicians no Longer Consider it Necessary |
| Study Start Date : | January 2017 |
| Estimated Primary Completion Date : | September 2019 |
| Estimated Study Completion Date : | December 2019 |
| 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. |
- 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
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02900820
| Contact: Carl Llor, GP | 0034693696644 | carles.llor@gmail.com | |
| Contact: Eva Tudela, PhD | 0034933170333 | etudela@semfyc.es |
| Spain | |
| Coll d'en Rabassa Primary Health Center | Not yet recruiting |
| Palma de Mallorca, Balearic Islands, Spain, 07006 | |
| Contact: Julio F Fóthy, MD 0034902079079 juliof.fothy@gmail.com | |
| Manso - Via Roma Primary Care Center | Recruiting |
| Barcelona, Catalonia, Spain, 08015 | |
| Contact: Carl Llor, PhD MD 0034933268901 carles.llor@gmail.com | |
| La Marina Primary Care Center | Not yet recruiting |
| Barcelona, Catalonia, Spain, 08038 | |
| Contact: Carolina Bayona, PhD MD 0034932988850 cbayona.bcn.ics@gencat.cat | |
| Guinardó Primary Care Center | Not yet recruiting |
| Barcelona, Catalonia, Spain, 08041 | |
| Contact: Albert Boada, MD 0034934462950 aboadav.bcn.ics@gencat.cat | |
| Jaume I Primary Care Center | Recruiting |
| Tarragona, Catalonia, Spain, 43005 | |
| Contact: Ana Moragas, PhD MD 0034977247211 anamaria.moragas@urv.cat | |
| Study Director: | Josep M Cots, Professor | University of Barcelona |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Carl Llor, Principal Investigator, Spanish Society of Family and Community Medicine |
| ClinicalTrials.gov Identifier: | NCT02900820 History of Changes |
| Other Study ID Numbers: |
16/101 |
| First Posted: | September 14, 2016 Key Record Dates |
| Last Update Posted: | November 1, 2018 |
| Last Verified: | October 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
|
Anti-Bacterial Agents Primary Health Care Drug Resistance, Microbial Respiratory Tract Infections |
|
Infection Communicable Diseases Respiratory Tract Infections Respiratory Tract Diseases |
Anti-Bacterial Agents Antibiotics, Antitubercular Anti-Infective Agents Antitubercular Agents |