Revisions for Results of an antimicrobial stewardship program | Registro Público Cubano de Ensayos Clínicos

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Revision of 21 December 2020 - 10:35am:

Results of an antimicrobial stewardship program

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Acronym of Public Title:

PROGEAN-FARM

Scientific title:

Results of antimicrobial stewardship program in a tertiary care hospital: ambispective cohort study

Acronym of Scientific Title:

PROGEAN-FARM

Secondary indentifying numbers:

No applicable

Issuing authority of the secondary identifying numbers:

No applicable

Source(s) of monetary or material support:

Pharmaceutical Promotion and Prevention Research Group (Antioquia University) Clinica Medellin

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Only approved by Ethics Committees

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Pedro

Midle name:

Jose

Last name:

Amariles Munnoz

Medical Specialty :

Pharmacist PhD Clinical Pharmacology

Affiliation:

Antioquia University

Postal address:

Calle 70 No. 52 - 21

City:

Medellin

Country:

Colombia

Zip Code:

1226

Telephone:

+57-42195460

Email address:

pedro.amariles@udea.edu.co

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Colombia

Clinical sites:

Medellin, Clinica Medellin S.A. Hector Alejandro Holguin Yepes. Pharmacist

Research ethics committees:

Ethics and Research Committee, Clinica Medellin, August 4th 2016

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Complete

Date of first enrollment:

05/08/2016

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Infectious diseases

Health condition(s) code:

Communicable Diseases

Infection

Environmental Illness

Intervention(s):

The study is composed of two cohorts, a prospective cohort or exposed to the protective factor (considering a protective factor as the evaluation of antimicrobial therapy by the Pharmacist in the environment of the antimicrobial stewardship program) and a retrospective, historical or non-historical cohort. exposed to the protective factor. Clinical rounds will be carried out by the Pharmacist to all the reference population that meets the inclusion and exclusion criteria. As a methodology for pharmacotherapeutic follow-up (FTS), the DADER method will be used, which is a standardized medical model to organize information on health problems, in which, the records are oriented to the health problems of the patients. Each clinical problem will be identified and subjective data will be established, objective and analyzed and defined a plan to solve it, which will be discussed later with the treating physician, further evaluating the acceptance or not. For the evaluation through the DADER method, the following variables should be taken into account during the evaluation of antimicrobial pharmacotherapy: a) indication, b) effectiveness, c) adverse reactions and d) costs; And of complete therapy: a) duplicity and b) drug interactions. The unexposed cohort is a retrospective population (July 2016 backwards) that is similar (paired) in sociodemographic, clinical and microbiological terms to the exposed cohort, but has not received an evaluation of its antimicrobial therapy within the antimicrobial stewardship program.

Intervention code:

Antimicrobial Stewardship

Program Evaluation

Evaluation of Results of Therapeutic Interventions

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

Consumption of carbapenemic antimicrobials (The Defined Daily Dose will be used as a mean daily dose when a drug (antibiotic) is used in its main indication in adults. In this case, the daily dose defined by 100 patient-days will be calculated, using the formula DDD/100 patients-day = g Antimicrobial x (100 / DDD specific (g) n ° days x n ° patients)). Measurement time: at the end of antibiotic treatment.

Key secondary outcomes:

Duration of antibiotic treatment (It will be measure in Days). Measurement time: at the end of antibiotic treatment. Costs associated with antibiotic treatment (It will be measure in American dollars). Measurement time: at the end of antibiotic treatment.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

18 years

Maximum age:

None

Inclusion criteria:

1. Patient older than 18 years. 2. Patients who, within their pharmacotherapy, have a minimum prescribed one of the following antibiotics: • Penicillins: Piperacillin / Tazobactam. • Cephalosporins: Ceftriaxone, Ceftazidime, Cefepime, Ceftaroline. • Carbapenems: Meropenem, Doripenem, Imipenem / Cilastatin, Ertapenem. • Quinolones: Ciprofloxacin. • Glycopeptides: Vancomycin. • Polymyxins: Polymyxin B, Colistin • Oxazolidinones: Linezolid. • Cyclic lipopeptides: Daptomycin. • Tetracyclines: Tigecycline.

Exclusion criteria:

1. Patients without the first evaluation by the treating medical specialty. 2. Patients receiving extracorporeal membrane oxygenation (ECMO). 3. Patients with cystic fibrosis. and. Administration of antimicrobials subcutaneously, intraperitoneally or intrathecally. 4. Patients admitted to surgery and hemodynamics.

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Observational

Purpose:

Prevention

Allocation:

Non-randomized controlled trial

Masking:

Open

Control group:

Historical

Study design:

Other

Other design:

Ambispective cohort study

Phase:

N/A

Target sample size:

514

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Hector

Middle Name:

Alejandro

Last Name:

Holguin Yepes

Specialty:

Pharmacist

Affiliation:

Clínica Medellin

Postal Address:

Carrera 65 B No. 30 - 95

City:

Medellin

Country:

Colombia

Zip Code:

050030

Telephone:

+57-3003537955

Email :

hector.holguin30@gmail.com

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Hector

Middle Name:

Alejandro

Last Name:

Holguin Yepes

Specialty:

Pharmacist

Affiliation:

Clínica Medellín S.A.

Postal Address:

Carrera 65 B No. 30 - 95

City:

Medellin

Country:

Colombia

Zip Code:

050030

Telephone:

+57-3003537955

Email :

hector.holguin30@gmail.com

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000275

Date of Registration in Primary Registry:

30/05/2018

Record Verification Date:

2020/12/21

Next update date:

2021/12/21

Link to the spanish version:

Click here

Registered Trials

Registration process

Results of an antimicrobial stewardship program

About the RPCEC

Useful resources