Condition category
Infections and Infestations
Date applied
24/04/2012
Date assigned
08/05/2012
Last edited
14/11/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Lay summary under review 3

Trial website

Contact information

Type

Scientific

Primary contact

Prof M. Carmen Fariñas

ORCID ID

Contact details

Avd. Valdecilla s7n
Santander
39008
Spain

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

API 06/03-PI06/90094

Study information

Scientific title

A PRogram to Optimize the quality of Antibiotic use within the hospital - impact on antibiotic consumption, cost savings and bacterial resistance: a randomized controlled study

Acronym

PROA

Study hypothesis

The prevalence of use of antimicrobial drugs in the hospital setting is very high. The economic cost involved is considerable and growing, and can be up to 30% of the cost of a hospital pharmacy. However, several studies have estimated that more than half of the prescriptions of antimicrobials in the hospital setting are inappropriate. This is not only for important economic consequences, but also clinics, which are drugs with a relevant role in the prognosis of patients and not free of side effects. But also its excessive and inappropriate use is linked to the unstoppable increase of antibiotic resistance to which we have been witnessing in recent years.

Implementation of a randomized controlled intervention with blind from the same analysis, aimed at optimizing the use of antimicrobial drugs in certain units of a tertiary hospital will reduce consumption and associated spending, improve the quality of the prescription and decrease the number of resistance to them.

Ethics approval

Hospital Universitario Marqués de Valdecilla, Santander, Spain, 24 May 2006
Clinical Investigation Committee of Community of Cantabria 19 May 2006

Study design

Randomized controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Patients on antibiotic therapy

Intervention

Patients with 3 day antibiotic treatment will be identified by the pharmacy service daily from Monday to Friday. Once checked the inclusion criteria, there will be the randomization stratified by clinical units, through the generation of random numbers generated by computer. The fellow of the project will come to review clinical data of the patient and shall obtain the microbiological data to the microbiology service the same day in which the case has been identified.Then, in the intervention group, under the advice of researchers in the team, will develop a simple and concise, recommendations on the use of antimicrobials in the specific case: suspension of the / the same, modification of dose, route of administration, change of antimicrobial modification / s, obtaining of levels in a standardized written form, developed specifically for this purpose, that it will be included in the active medical history of patient, to be included in the active clinical history of the patient. The recommendations will include a phone contact so that the responsible clinician can, if desired, please contact with the fellow. Initially intervention will be leave to the recommendations in writing, though it can occur is to comment verbally to the prescriber. The fellow in no case will directly make the prescription.Recommendations will focus, above all, on the following:

1. Correct indication of antibioterapia
2. Boost sequential therapy and reduce unwarranted use of parenteral antibiotic
3. Adequacy of the treatment identified microorganisms
4. Proper dosage and duration

These recommendations will be based on the recommendations and guidelines on the use of antibiotics published in literature, as well as with the rules established by the Commission of Hospital infections. With these fundamentals, the team shall draw up common guidelines to guide recommendations.
In this first visit to the patient will be collected data concerning the patient, reason for the antibiotic indication and made recommendation. Day 7 after the start of antimicrobial treatment will be a second visit to the patient in which data concerning adherence to the recommendation made on the first visit will be collected. If the 7 day is convenient to make a new recommendation will take place in the same way as the previous. In the 48-72 hours will evaluate whether or not there has been adherence to the recommendation.

Infectious Diseases Consultation was also available as part of daily practice for physicians treating patients in the non-intervention group (without insertion of written recommendations), in this case the patient was withdrawn from the study.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. To know the current situation of antibiotic use in the Valdecilla Hospital
2. To evaluate the impact of an intervention designed to optimize the antibiotic consumption and cost, as well as the incidence of bacterial resistance in some hospitalization units

Secondary outcome measures

1. To analyze the impact of the intervention on the microbiological and clinical prognosis of patients, as well as half of them stay
2. To investigate the adhesion of medical intervention and the impact of such adherence on the microbiological and clinical prognosis of patients
3. To investigate if the results obtained with the intervention are maintained over time

Overall trial start date

01/01/2007

Overall trial end date

30/06/2009

Reason abandoned

Eligibility

Participant inclusion criteria

Patients:
The reference population is composed of patients admitted in the Hospital Universitario Marqués de Valdecilla with antimicrobial treatment prescribed by their responsible doctors for more than three days.
The clinical services/units in which the study will be realized will comply with the following criteria for inclusion:
1. Stability in the physicians who participate in the study
2. Stability in the number of beds and type of assisted
3. Agreement by doctors who work in them to participate in the study

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Assuming that prescription may be inadequate in up to 50% of cases, Alpha risk of 5%, with a power of up to 80%, to detect at least 10% differences between groups (RR = 0.8), needed 816 patients

Participant exclusion criteria

1. Pediatric patients
2. Patients with terminal chronic renal failure (on dialysis)
3. Patients with oral antibiotic treatment
4. Antibiotic treatment already prescribed by the Infectious Diseases Unit
Patients whose antibiotic has been prescribed by a member of the Infectious Diseases Unit as part of the usual care task shall be excluded from the study

Recruitment start date

01/01/2007

Recruitment end date

30/06/2009

Locations

Countries of recruitment

Spain

Trial participating centre

Avd. Valdecilla s7n
Santander
39008
Spain

Sponsor information

Organisation

Training and Research Institute, Marqués de Valdecilla (Spain)

Sponsor details

[Instituto de Formación e Investigación Marqués de Valdecilla] (IFIMAV)
Av. Cardenal Herrera Oria s/n
Santander
39011
Spain

Sponsor type

University/education

Website

http://www.fmdv.org

Funders

Funder type

Government

Funder name

Ministry of health of Spain (Spain) - Fondo de Investigaciones Sanitarias ref: FIS PI06/90094

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Training and Research Institute Marqués de Valdecilla (Instituto de Formación e Investigación Marqués de Valdecilla) (IFIMAV) (Spain) ref: API 06/03

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/23140210

Publication citations

  1. Results

    Fariñas MC, Saravia G, Calvo-Montes J, Benito N, Martínez-Garde JJ, Fariñas-Alvarez C, Aguilar L, Agüero R, Amado JA, Martínez-Martínez L, Gómez-Fleitas M, Adherence to recommendations by infectious disease consultants and its influence on outcomes of intravenous antibiotic-treated hospitalized patients., BMC Infect. Dis., 2012, 12, 292, doi: 10.1186/1471-2334-12-292.

Additional files

Editorial Notes