Patient Factors Associated With Prescription of Antibiotics for Inappropriate Indication in Patients With AECOPD
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|ClinicalTrials.gov Identifier: NCT03077152|
Recruitment Status : Unknown
Verified March 2017 by Yelda Varol, Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital.
Recruitment status was: Recruiting
First Posted : March 10, 2017
Last Update Posted : March 10, 2017
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.
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.
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.
Patient factors are not associated with the prescription of antibiotics for inappropriate indications in patients with AECOPD
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|
|Study Type :||Observational|
|Estimated Enrollment :||143 participants|
|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|
- 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.
- 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)
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
|Contact: Yelda Varol, MDemail@example.com|
|Dr. Suat Seren Chest Diseases and Surgery Education and Training Hospital||Recruiting|
|Izmir, Turkey, 35050|
|Contact: Yelda Varol, MD 905057690269 firstname.lastname@example.org|
|Principal Investigator:||Yelda Varol, MD||Izmir Dr. Suat Seren Chest Diseases and Surgery Education and Training Hospital|