Safety of Discontinuing Patient Antibiotic Treatment

NCT02900820 | Completed DMC

• 1 other identifier: 16/101
• Study Type: interventional
• Target: 430
• Locations: 1 country
• Sites: 5

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.

Conditions

Infectious Diseases; Respiratory Tract Infections

Keywords

Anti-Bacterial Agents; Primary Health Care; Drug Resistance, Microbial; Respiratory Tract Infections

Outcome Measures

Primary Outcomes (1)

• Duration of severe symptoms

  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 Outcomes (5)

• Adverse effects of the medication

  From index visit to 28 days after the initial visit

• Antibiotic consumption

  From index visit to day 28

• Satisfaction with health care by means of a questionnaire

  Day 28 after the index visit

• Belief in the effectiveness of antibiotic therapy by means of a questionnaire

  Day 28 after the index visit

• Rate of complications

  Within the first 3 months

Study Arms (2)

Novel intervention group

EXPERIMENTAL

Discontinuing antibiotic therapy.

Other: Discontinuing antibiotic therapy

Usual intervention group

EXPERIMENTAL

Usual strategy of continuing antibiotic treatment.

Other: Continuing antibiotic therapy

Interventions

Discontinuing antibiotic therapy OTHER

Patients assigned to this group will be asked to discontinue antibiotic therapy.

Novel intervention group

Continuing antibiotic therapy OTHER

Patients assigned to this group will be asked to complete antibiotic therapy.

Usual intervention group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Spanish Society of Family and Community Medicine: lead

Study Sites (5)

Coll d'en Rabassa Primary Health Center

Palma de Mallorca, Balearic Islands, 07006, Spain

Location

Manso - Via Roma Primary Care Center

Barcelona, Catalonia, 08015, Spain

Location

La Marina Primary Care Center

Barcelona, Catalonia, 08038, Spain

Location

Guinardó Primary Care Center

Barcelona, Catalonia, 08041, Spain

Location

Jaume I Primary Care Center

Tarragona, Catalonia, 43005, Spain

Location

Related Publications (7)

• 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.

  PMID: 25669463 BACKGROUND

• Costelloe 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.

  PMID: 20483949 BACKGROUND

• Dekker 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.

  PMID: 25911505 BACKGROUND

• Morgan 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.

  PMID: 21659004 BACKGROUND

• Goossens 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.

  PMID: 15708101 BACKGROUND

• Llor 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.

  PMID: 34363942 DERIVED

• Llor 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.

  PMID: 28592581 DERIVED

MeSH Terms

Conditions

Communicable Diseases; Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiratory Tract Diseases

Study Officials

• Josep M Cots, Professor

  University of Barcelona

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 6, 2016
• First Posted: September 14, 2016
• Study Start: January 1, 2017
• Primary Completion: June 1, 2020
• Study Completion: December 1, 2020
• Last Updated: September 21, 2021

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share

Locations

ES (5)