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

ConditionCommunity Acquired Infections
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorFundación Pública Andaluza para la gestión de la Investigación en Sevilla

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Emergency departments.

Odontology offices.

DDD per Health centre less than 5.78

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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).

  • Standard training

    Behavioral

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

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Enhanced education armExperimental treatment 1 intervention
Group B: Standard education armActive comparator 1 intervention

Trial outcomes

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.

Time frame
Monthly over a 36-month period

Secondary outcomes

1

Adequacy of antimicrobial prescriptions

The rate of appropriate antimicrobial prescriptions according to national reference guidelines will be assessed through three point prevalence surveys of randomly selected prescriptions.

Time frame
Prevalence surveys will be performed at months +0, +7 and +15.
2

Incidence density of hospitalizations due to infections

The incidence density of hospitalizations due to infections (urinary, pneumonia and skin and soft tissue infections), and specifically due to Clostridiodes difficile infections per inhabitant.

Time frame
Monthly, over a 36-month period.
3

Incidence density of resistant Enterobacterales in urine cultures

Incidence density of resistant Enterobacterales in urine cultures per inhabitant sent from Primary Care centers from both arms.

Time frame
Monthly, over a 36-month period.

Other outcomes

Sponsors and contacts

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Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Lead sponsor

Source ClinicalTrials.gov
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