Infectious Diseases Experts as Part of the Antibiotic Stewardship Team in Primary Care

NCT04848883 | Completed DMC

• 1 other identifier: PR277/19
• Study Type: interventional
• Target: 1,389
• Locations: 1 country
• Sites: 1

Brief Summary

A cluster-randomised multicentre blinded clinical trial will be performed in six primary care centres located in the southern metropolitan area of Barcelona (Spain). The objective is to assess whether including experts on infectious diseases (ID) within the antimicrobial stewardship (AMS) team of primary care achieves higher reductions on overall antibiotic consumption and increases the quality of prescription in diagnosed upper respiratory and urinary tract infections. Centres will be randomly assigned to receive a standard-AMS or an advanced-AMS (intervention). Advanced-AMS includes all standard-AMS strategies plus general practitioner chance to discuss clinical cases by telephone to ID expert on working days (8:00 am to 8:00 pm), and by biweekly meetings.

Conditions

Infectious Disease

Keywords

Antimicrobial stewardship program; Primary care; Infectious disease specialist; Bacterial resistance

Outcome Measures

Primary Outcomes (1)

• To asses the impact of implementing an advanced-AMS program (inclusion of infectious diseases specialists) on the overall antibiotic consumption.

  Antibiotic defined daily dose per 1,000 inhabitant's day (DHD).

  Through study completion

Secondary Outcomes (5)

• Number of patients with unnecessary antibiotic prescriptions on upper respiratory tract infections.

  Through study completion

• Number of patients with unnecessary antibiotic prescriptions on urinary tract infections.

  Through study completion

• Number of patients with an adequate antibiotic treatment

  Through study completion

• Number of patients re-consulting after completing antibiotic therapy.

  Through study completion

• Number of cases who needs hospitalisation 30 days after antibiotic therapy.

  Through study completion

Study Arms (2)

Advanced AMS program

EXPERIMENTAL

Three randomily assigned primary care centres in which an infectious diseases expert will be continuously in touch with primary care practitioners.

Behavioral: Advanced AMS program; Behavioral: Standard AMS program

Standard AMS program

ACTIVE COMPARATOR

Three primary care centres in which a typical AMS will be promoted.

Behavioral: Standard AMS program

Interventions

Advanced AMS program BEHAVIORAL

1. \- Telephone acces to infectious disease experts to discuss patients' therpies during working days. 2. \- Biweeckly meetings with infectious diseases experts and antimicrobial stewardship group.

Advanced AMS program

Standard AMS program BEHAVIORAL

1. \- Educational materials. 2. \- Updated local antibiotic guidelines. 3. \- Promotion of delayed antibiotic prescription. 4. \- Promotion of Streptococcus pyogenes antigen test (Streptotest) if bacterial tonsillitis is suspected. 5. \- Daily report to GP of multiresistant bacteria isolates in urinary samples. 6. \- Quarterly reports to prescribers of AMS outcomes at the centre-level.

Advanced AMS program; Standard AMS program

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary care centres belonging to the Delta del Llobregat healthcare area.
• Prior experience in clinical research and formal agreement to participate in the study.
• Comparability of their reference populations.

You may not qualify if:

• Adult patients (aged \>14 years).
• Diagnosed with an acute URTI (including pharyngoamygdalitis, sinusitis, otitis) or UTI (including cystitis, prostatitis, pyelonephritis) during the study period.
• Patients attended by a GP at the selected centres.
• Eligible patients will be identified following the International Classification of Diseases (ICD-10) CM codes as follows:
• URTI: J00, J01, J02, J03, J04, J05, J06, J31, J39, H60, H62, H65, H66, H67, H83 and H92.
• UTI: N10, N30, N39, N41, R82 and O23.
• Patients less than 14 years old.
• Patients with indwelling urinary catheter.
• Patients with congenital urinary tract abnormalities.
• Pregnant women.
• Patients undergoing urological surgery.

Sponsors & Collaborators

• Institut d'Investigació Biomèdica de Bellvitge: lead

Study Sites (1)

Hospital Univeristari de Bellvitge

Barcelona, Catalonia, s/n, Spain

Location

Related Publications (21)

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MeSH Terms

Conditions

Communicable Diseases

Condition Hierarchy (Ancestors)

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

Study Officials

• Ariadna Padullés, Pharmacyst

  Institut d'Investigació Biomèdica de Bellvitge

  STUDY DIRECTOR

• Evelyn Shaw, Doctor

  Institut d'Investigació Biomèdica de Bellvitge

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The two secondary endpoints, unnecessary antibiotic therapy and adequacy of therapy, will be evaluated by blinded investigators. Discrepant decisions among them will be discussed with a third blinded antibiotic expert to reach a consensus. Due to the nature of the intervention, it is not possible to blind the primary care centres or the GPs.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Cluster-randomised conducted across 6 primary care centres (El Castells from Castelldefels, Prat de Llobregat 2, Gava 1, Viladecans 2, Hospitalet de Llobregat 2 Sant Josep and Santa Eulàlia Nord) within the Delta del Llobregat area (Barcelona, Spain), from June 2021 to March 2023. Randomisation will be performed at the cluster level (primary care centre). A centralised electronic computer-generated system will produce the allocation sequence using randomly permuted blocks. No significant differences between population features were observed in main characteristics of each centre. A priori, randomisation will help to keep the groups comparable. However, two centres had a larger referral population, and to ensure this point, a restriction would be introduced to the randomisation process to guarantee that the two centres with the highest referral populations will not fall into the same groups.

Study Record Dates

• First Submitted: March 22, 2021
• First Posted: April 19, 2021
• Study Start: June 1, 2021
• Primary Completion: April 21, 2023
• Study Completion: June 30, 2024
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)