Clinical and Ecological Impact of a Primary Care Antimicrobial Stewardship Program Based on Telematic Educational Interviews (TELÉMACO Trial)

NCT06706583 | Recruiting

• 1 other identifier: TELÉMACO
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Brief Summary: Open-label, cluster randomized, multicenter clinical trial to evaluate the clinical and ecological impact of a Primary Care ASP based on telematic educational interviews.

Conditions

Community Acquired Infections

Keywords

Antimicrobial Stewardship Program (ASP); Primary Care; Telemedicine; PIRASOA

Outcome Measures

Primary Outcomes (1)

• Total antimicrobial consumption

  Total antimicrobial antimicrobial will be measured using the recommended international standard, the Defined Daily Dose (DDD) per 1000 inhabitants per day. Predefined subgroup analyses will be conducted to assess the intervention\'s effect on the primary outcome based on: patient age, geneder, and socioeconomic level.

  Monthly over a 36-month period

Secondary Outcomes (3)

• Adequacy of antimicrobial prescriptions

  Prevalence surveys will be performed at months +0, +7 and +15.

• Incidence density of hospitalizations due to infections

  Monthly, over a 36-month period.

• Incidence density of resistant Enterobacterales in urine cultures

  Monthly, over a 36-month period.

Study Arms (2)

Enhanced education arm

EXPERIMENTAL

Telematic educational interviews are added to standard PIRASOA training

Behavioral: Telematic educational interviews + standard training

Standard education arm

ACTIVE COMPARATOR

Only standard PIRASOA training is provided

Behavioral: Standard training

Interventions

Telematic educational interviews + standard training BEHAVIORAL

Physicians attending at healthcare centers in the experimental arm will receive periodic telematic educational interviews in which an Infectious Diseases consultant will provide practical training on the appropriate use of antibiotics through the review of one of the physician´s randomly chosen antibiotic prescription, according to a structured brief interview. In addition to this, each of these centres will continue carrying out the already established activities of the Regional ASP (PIRASOA).

Enhanced education arm

Standard training BEHAVIORAL

Primary Care Health Centers assigned to the control group will receive standard educational activities designated by the current Regional ASP (PIRASOA).

Standard education arm

Eligibility Criteria

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

You may qualify if:

• a) Primary Care centres within the reference area of the University Hospital Virgen del Rocío.

You may not qualify if:

• Emergency departments.
• Odontology offices.
• DDD per Health centre less than 5.78

Sponsors & Collaborators

• Fundación Pública Andaluza para la gestión de la Investigación en Sevilla: lead

Study Sites (1)

Hospital Universitario Virgen del Rocío

Seville, 41013, Spain

RECRUITING

MeSH Terms

Conditions

Community-Acquired Infections

Condition Hierarchy (Ancestors)

Infections

Study Officials

• José Miguel Cisneros Herreros, MD-PhD

  Hospitales Universitarios Virgen del Rocío

  STUDY DIRECTOR

Central Study Contacts

Clara M Rosso Fernández, MD-PhD

CONTACT

+34955013414; claram.rosso.sspa@juntadeandalucia.es

Jose Molina Gil-Bermejo, MD-PhD

CONTACT

josemolinagb@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cluster randomized clinical trial

Study Record Dates

• First Submitted: November 22, 2024
• First Posted: November 26, 2024
• Study Start: December 1, 2024
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: November 26, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share

Locations

ES (1)