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Patient Factors Associated With Prescription of Antibiotics for Inappropriate Indication in Patients With AECOPD

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ClinicalTrials.gov Identifier: NCT03077152
Recruitment Status : Recruiting
First Posted : March 10, 2017
Last Update Posted : March 10, 2017
Sponsor:
Information provided by (Responsible Party):
Yelda Varol, Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital

Brief Summary:

Up to 90% of consulting Acute Exacerbation (AE) of COPD patients are prescribed an antibiotic(1).

Rates of inappropriate antibiotic prescription percentage can be as high as 65%(2).

Excessive use of antibiotics is correlated with higher prevalence of antimicrobial resistance(3). There are insufficient data regarding the overprescribing antibiotics in AECOPD in our country.Therefore the investigators aimed to investigate the patients factors that are associated with the prescription of antibiotic for inappropriate indication in AECOPD.This is an observational cross sectional study.Population: AECOPD patients with AB(antibiotic) prescription Exposure: Presence of patient factors, Comparison: Absence of Patient factors, Outcome: Prescription of antibiotic for inappropriate indication.

Sampling:

Consecutive patients presenting to pharmacy between Monday and Friday. Date between January 1 2017 to January 1 30 2019. Primary Outcome:Prescription of antibiotic for inappropriate indication according to Anthonisen criteria for AECOPD Anthonisen criteria:-Worsening of dyspnea

  • Increased sputum volume
  • Increased sputum purulent 3/3 →Type 1 or severe AE 2/3 →Type 2 or moderate AE 1/3 →Type 3 or mild AE AB indicated/useful in Type 1 or severe AE, and Type 2 or moderate AE if sputum is purulent The data will be obtained from the database.

Exposure:

Patient factors that lead to inappropriate antibiotic prescription (will be considered together in analysis due to confounding) FEV1% Age Current smoker Comorbidities (Charlson comorbidity index) having Frequent exacerbations (≥2 past year) Use of oral steroids Polypharmacy Quality control:Detailed MOP will be developed, A manual for protocol will be written and used to inform the pharmacist,Pharmacist will be trained; to speak to participants in a neutral manner for written informed consent for the security ID(identity) data of the patients,This study will not affect the time period of the participants to access his/her drug. The pharmacy will use the questionnaire within the time period planned. A checklist for exclusion criteria will be developed. A plan for missing data will be developed.

Null hypothesis:

Patient factors are not associated with the prescription of antibiotics for inappropriate indications in patients with AECOPD

Alternative hypothesis:

Patient factors are associated with the prescription of antibiotics for inappropriate indications in patients with AECOPD Analysis The data will be analysed using SPSS version 22.0 The investigators will compare exposure variables between inappropriate and appropriate prescription groups Continuous variables - t test or Mann Whitney Binary- chi square test The investigators will use logistic regression to measure the associations between patient factors and the outcome of prescription of antibiotics for inappropriate indication Sample size and power Sample size to estimate CI of 15% around 25 to 50% prevalence of inappropriate prescription with p=0.05 and Power 80% Expected proportion0,25 128 0,50 171 Sample size and power For logistic regression - estimate 30% prevalence (n=143), or about 42 events . The investigators also need 5-10 events for each variable in the model, so this provides sufficient power for 4 to 8 factors.

Limitations This study will just determine an association not causality

The investigators won't be able to determine if the participant is truthful to the pharmacist

The history of participants will be assessed from hospitals e-database - potential for missing data.

The Anthonisen criteria for identifying inappropriate AB for AECOPD are still debatable The investigators can not modify many of the patient factors, but may be able to identify patients at higher risk of inappropriate antibiotics Ethics The project will be submitted to the ethical committee of Dr. Suat Seren Chest Disease Hospital Oral and written informed consent will be obtained from all subjects The study will be conducted in accordance with "Good Clinical Practice Guideline" Relevance This study will be the first one to evaluate an association between patient factors and prescription of antibiotic for inappropriate indication in an outpatient clinic of patients with AECOPD in Turkey.

Subsequent studies should evaluate physician factors prescription of antibiotic for inappropriate indication.


Condition or disease
Chronic Obstructive Pulmonary Disease Acute Exacerbation of COPD

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Study Type : Observational
Estimated Enrollment : 143 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Patient Factors Associated With Prescription of Antibiotics for Inappropriate Indication in Patients With AECOPD
Actual Study Start Date : January 1, 2017
Estimated Primary Completion Date : January 1, 2019
Estimated Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics




Primary Outcome Measures :
  1. Number of participants who has a prescription of antibiotic for inappropriate indication for AECOPD according to Anthonisen criteria [ Time Frame: 3 months ]
    Prescription of antibiotic is indicated in type 1 or severe exacerbation (3/3 Antjonisen critaria) or type 2 or moderate exacerbation if one of the symptoms are purulens of sputum.In mild exacerbation (1/3 criteria) it is not indicated.


Secondary Outcome Measures :
  1. Patient factors that may lead to prescribe inappropriate antibiotic prescription [ Time Frame: 6 months ]
    Probable Patient factors that lead to inappropriate antibiotic prescription are FEV1%, Age, being a current smoker, carlson comorbidity index, being a frequent exacerbator, use of oral steroids and polifarmacy (will be considered together in analysis due to confounding)



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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
AECOPD patients with Antibiotic prescription
Criteria

Inclusion Criteria:

  • Patients diagnosed with COPD according to GOLD criteria
  • Patients whom are prescripted an antibiotic for AECOPD in a chest diseases outpatient clinic
  • Prescriptions should be written by pulmonologists

Exclusion Criteria:

  • COPD patients using Long term oxygen treatment (LTOT) at home
  • COPD patients using Bilevel Positive airway pressure (BPAP) for type 2 respiratory failure
  • COPD patients whom have snother need for AB use (bronchiectasis Pneumonia etc.)
  • COPD patients with Positive sputum culture past 4 weeks
  • COPD patients whom have Hospitalisation for COPD past 4 weeks

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03077152


Contacts
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Contact: Yelda Varol, MD 905057690269 yeldavatansever@hotmail.com

Locations
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Turkey
Dr. Suat Seren Chest Diseases and Surgery Education and Training Hospital Recruiting
Izmir, Turkey, 35050
Contact: Yelda Varol, MD    905057690269    yeldavatansever@hotmail.com   
Sponsors and Collaborators
Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital
Investigators
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Principal Investigator: Yelda Varol, MD Izmir Dr. Suat Seren Chest Diseases and Surgery Education and Training Hospital

Publications:
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Responsible Party: Yelda Varol, Principal Investigator MD, Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital
ClinicalTrials.gov Identifier: NCT03077152     History of Changes
Other Study ID Numbers: IGHCEAH
First Posted: March 10, 2017    Key Record Dates
Last Update Posted: March 10, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yelda Varol, Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital:
copd, aecopd, antibiotic use

Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents