Chronic Obstructive Pulmonary DiseaseNCT03077152
Patient Factors Associated With Prescription of Antibiotics for Inappropriate Indication in Patients With AECOPD
An observational study of Chronic Obstructive Pulmonary Disease and Acute Exacerbation of COPD, run by Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Acute Exacerbation of COPD
- How many people
- 138 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2017to 1 Sep 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: AECOPD patients with Antibiotic prescription
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dr. Suat Seren Chest Diseases and Surgery Education and Training Hospital
Izmir, 35050
About this study
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).
Read more
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.
- Keywords
- copd, aecopd, antibiotic use
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who has a prescription of antibiotic for inappropriate indication for AECOPD according to Anthonisen criteria
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.
Measured: 3 months
Secondary outcomes (1)
Patient factors that may lead to prescribe inappropriate antibiotic prescription
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)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2017
- Study start1 Jan 2017
- Primary completion1 Sep 2018
- Study completion1 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yelda Varol, Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital
- Investigators
- Yelda Varol, MD, Principal investigator, Izmir Dr. Suat Seren Chest Diseases and Surgery Education and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03077152
- Sponsor's protocol ID
- IGHCEAH
- Status last verified
- Aug 2020
- First submitted
- 28 Feb 2017
- Last updated
- 11 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Llor C, Bjerrum L, Munck A, Hansen MP, Cordoba GC, Strandberg EL, Ovhed I, Radzeviciene R, Cots JM, Reutskiy A, Caballero L. Predictors for antibiotic prescribing in patients with exacerbations of COPD in general practice. Ther Adv Respir Dis. 2013 Jun;7(3):131-7. doi: 10.1177/1753465812472387. Epub 2013 Jan 16.
PubMed 23325784Tobia CC, Aspinall SL, Good CB, Fine MJ, Hanlon JT. Appropriateness of antibiotic prescribing in veterans with community-acquired pneumonia, sinusitis, or acute exacerbations of chronic bronchitis: a cross-sectional study. Clin Ther. 2008 Jun;30(6):1135-44. doi: 10.1016/j.clinthera.2008.06.009.
PubMed 18640469Bronzwaer SL, Cars O, Buchholz U, Molstad S, Goettsch W, Veldhuijzen IK, Kool JL, Sprenger MJ, Degener JE; European Antimicrobial Resistance Surveillance System. A European study on the relationship between antimicrobial use and antimicrobial resistance. Emerg Infect Dis. 2002 Mar;8(3):278-82. doi: 10.3201/eid0803.010192.
PubMed 11927025Anthonisen NR, Manfreda J, Warren CP, Hershfield ES, Harding GK, Nelson NA. Antibiotic therapy in exacerbations of chronic obstructive pulmonary disease. Ann Intern Med. 1987 Feb;106(2):196-204. doi: 10.7326/0003-4819-106-2-196.
PubMed 3492164
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Factors Associated With Prescription of Antibiotics for Inappropriate Indication in Patients With AECOPD
- ClinicalTrials.gov ID
- NCT03077152
- Acronym / sponsor ID
- IGHCEAH
- Keywords
- copd, aecopd, antibiotic use
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research HospitalUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Sep 2018 (actual)
- Study completion
- 1 Sep 2018 (actual)
- First posted
- 10 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- AECOPD patients with Antibiotic prescription
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Patient factors that may lead to prescribe inappropriate antibiotic prescription
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2020.
- Background: PubMed 23325784Llor C, Bjerrum L, Munck A, Hansen MP, Cordoba GC, Strandberg EL, Ovhed I, Radzeviciene R, Cots JM, Reutskiy A, Caballero L. Predictors for antibiotic prescribing in patients with exacerbations of COPD in general practice. Ther Adv Respir Dis. 2013 Jun;7(3):131-7. doi: 10.1177/1753465812472387. Epub 2013 Jan 16.
- Background: PubMed 18640469Tobia CC, Aspinall SL, Good CB, Fine MJ, Hanlon JT. Appropriateness of antibiotic prescribing in veterans with community-acquired pneumonia, sinusitis, or acute exacerbations of chronic bronchitis: a cross-sectional study. Clin Ther. 2008 Jun;30(6):1135-44. doi: 10.1016/j.clinthera.2008.06.009.
- Background: PubMed 11927025Bronzwaer SL, Cars O, Buchholz U, Molstad S, Goettsch W, Veldhuijzen IK, Kool JL, Sprenger MJ, Degener JE; European Antimicrobial Resistance Surveillance System. A European study on the relationship between antimicrobial use and antimicrobial resistance. Emerg Infect Dis. 2002 Mar;8(3):278-82. doi: 10.3201/eid0803.010192.
- Background: PubMed 3492164Anthonisen NR, Manfreda J, Warren CP, Hershfield ES, Harding GK, Nelson NA. Antibiotic therapy in exacerbations of chronic obstructive pulmonary disease. Ann Intern Med. 1987 Feb;106(2):196-204. doi: 10.7326/0003-4819-106-2-196.
- Individual participant dataSharing planned: Undecided
Related trials for Chronic Obstructive Pulmonary Disease
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yelda Varol, MD principal investigator
Izmir Dr. Suat Seren Chest Diseases and Surgery Education and Training Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease and Acute Exacerbation of COPD, run by Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who has a prescription of antibiotic for inappropriate indication for AECOPD according to Anthonisen criteria (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03077152, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2020.