Respiratory Tract Infections Clinical Trial
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.
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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05525494 -
Patient Portal Flu Vaccine Reminders (5)
|
N/A | |
Completed |
NCT04537663 -
Prevention Of Respiratory Tract Infection And Covid-19 Through BCG Vaccination In Vulnerable Older Adults
|
Phase 4 | |
Terminated |
NCT04583280 -
A Study of Rilematovir in Infants and Children and Subsequently in Neonates Hospitalized With Acute Respiratory Tract Infection Due to Respiratory Syncytial Virus (RSV)
|
Phase 3 | |
Completed |
NCT03321968 -
Lot-to-lot Consistency of a Plant-Derived Quadrivalent Virus-Like Particles Influenza Vaccine in Healthy Adults
|
Phase 3 | |
Active, not recruiting |
NCT03251196 -
TB Sequel: Pathogenesis and Risk Factors of Long-term Sequelae of Pulmonary TB
|
||
Completed |
NCT02561871 -
A Study to Evaluate the Safety, Tolerability and Immunogenicity of Ad26.RSV.FA2 Followed by Ad35.RSV.FA2 in Healthy Adult Volunteers
|
Phase 1 | |
Completed |
NCT01911143 -
A Retrospective, Blinded Validation of a Host-response Based Diagnostics
|
N/A | |
Terminated |
NCT02032056 -
Effect of Probiotics in Reducing Infections and Allergies in Young Children During the Complementary Feeding Period
|
N/A | |
Terminated |
NCT01432080 -
Steroids, Azithromycin, Montelukast, and Symbicort (SAMS) for Viral Respiratory Tract Infection Post Allotransplant
|
Phase 2 | |
Completed |
NCT01419262 -
DO IT Trial: Vitamin D Outcomes and Interventions In Toddlers
|
Phase 3 | |
Completed |
NCT00984945 -
Safety Study of a Plant-based H5 Virus-Like Particles (VLP) Vaccine in Healthy Adults
|
Phase 1 | |
Completed |
NCT00127686 -
Effect of Honey and Dextromethorphan on Nocturnal Cough and Sleep
|
Phase 1 | |
Active, not recruiting |
NCT01107223 -
Long Term Effect of General Practitioner Education on Antibiotic Prescribing
|
N/A | |
Completed |
NCT03739112 -
Efficacy of a Plant-derived Quadrivalent Virus-like Particle (VLP) Vaccine in the Elderly
|
Phase 3 | |
Completed |
NCT04144491 -
Effect of L. Rhamnosus Yoba on RTI and Other Health Outcomes Among Children (3-6 Years) in Uganda
|
N/A | |
Completed |
NCT05318235 -
Virus Interactions in the Respiratory Tract; a Cohort Study With Children
|
||
Active, not recruiting |
NCT04170348 -
Daily Vitamin D for Sickle-cell Respiratory Complications
|
Phase 2 | |
Completed |
NCT04525040 -
ProbioKid as Prevention Among Kids With Frequent URTI
|
N/A | |
Completed |
NCT05535777 -
Patient Portal Flu Vaccine Reminders_RCT 5 (LADHS)
|
N/A | |
Not yet recruiting |
NCT05914324 -
Outpatient Pediatric Pulse Oximeters in Africa
|
N/A |