Acute Exacerbation COPDNCT06123780
Pattern of Microbial Infection in AECOPD Patients and Its Sensitivity to Antibiotics
An observational study of Acute Exacerbation COPD, run by Assiut University.
Trial summary
Measurement of bacterial species causing AECOPD and their Sensitivity pattern to antibiotics. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Exacerbation COPD
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2023to 1 Dec 2024
- 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 18 to 80 years
- All sexes
- Adult, Older adult
Study population: Demographic characteristics of these patients will be recorded, including sex, age, smoking status, underlying comorbidities, occupation and number of exacerbations. Clinical features will be recorded including increase grade of dyspnea , purulence and amount of sputum , history of previous NIV or MV. Spirometry as a confirmation tool of COPD. Arterial blood gases on admission. Complete blood count ( CBC ) and ESR Radiological profile of COPD patients. Sputum sample ; Spontaneous sputum sample by asking the patient to cough up sputum into sterile container. NIV patients : by spontaneous sputum sample. MV patients : by sputum suction through the endotracheal tube .
Who may be able to join
- Must be at least 18 years of age and less than 80 years of age for both genders
- Confirmed diagnosis of COPD by spirometry
- Must be an AECOPD patient (with increased grade of dyspnea, increased purulence and amount of sputum) and admitted to the chest department or ICU
- Positive sputum culture
Who cannot join
- Age less than 18 years old
- Any associated pulmonary co-morbidity
Trial locations and contacts
No sites are listed yet.
Ahmed H Mohammed, Professor contact
About this study
Official title: Pattern of Micro-bacterial Infection and Its Sensitivity to Antibiotics in COPD Patients With Acute Exacerbation.
Measurement of bacterial species causing AECOPD and their Sensitivity pattern to antibiotics.
Read the detailed description
Chronic obstructive pulmonary disease (COPD) is a major cause of chronic morbidity and mortality worldwide.
Acute exacerbation is a common problem during the natural course of COPD, which is characterized by an increase in the patient's daily symptoms of dyspnea, cough, and/or sputum beyond normal day-to-day variability and severe enough to require an additional therapy.
The most common cause of acute exacerbations of COPD (AECOPD) is an infection of the tracheobronchial tree and air pollution. As many as one-third of AECOPD causes are never identified. The microbial aetiology of AECOPD includes bacteria and viruses with more than 50% of cases being caused by bacterial infection.
The bacterial etiologies of AECOPD keep changing from time to time and the choice of antimicrobial depends upon on local prevalence of bacterial etiologies and their resistance pattern.
Antibiotics are the main form of treatment for AECOPD which are often initiated empirically based on healthcare provider's previous experiences , which often lead to the inappropriate use of antibiotics , thereby contributing to Antimicrobial Resistance.
Early diagnosis and knowledge of the predominant bacterial etiologies and antimicrobial resistance patterns will also help to correct treatment protocol for the management of AECOPD.
- Conditions
- Acute Exacerbation COPD
What is being measured
The primary outcome is the main question the study is designed to answer.
Pattern of Microbial infection based on sputum culture results.
Identification of causative Microbial organisms of AECOPD based on results of sputum culture.
Measured: Baseline
Pattern of antimicrobial sensitivities based on sputum culture results.
Identification of antimicrobial sensitivities and resistance patterns in this population based on results of sputum culture.
Measured: Baseline
Secondary outcomes (1)
Hospital length of stay
Exploring the relationship between the different causative organisms of AECOPD and the hospital length of stay.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start1 Dec 2023 (estimated)
- Primary completion1 Nov 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Acute Exacerbation COPDStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam Nazif Abdel-Tawab Mousa, Assiut University
- Investigators
- Khaled H. Ahmed, Professor, Study director, Assuit USamiaa H Sadek, Professor, Study director, Assuit U
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06123780
- Sponsor's protocol ID
- Bacteriology in AECOPD
- Status last verified
- Nov 2023
- First submitted
- 11 Oct 2023
- Last updated
- 22 Nov 2023
- Results posted
- No
Publications
Venkatesan P. GOLD report: 2022 update. Lancet Respir Med. 2022 Feb;10(2):e20. doi: 10.1016/S2213-2600(21)00561-0. Epub 2021 Dec 20. No abstract available.
PubMed 34942084Rodriguez-Roisin R. Toward a consensus definition for COPD exacerbations. Chest. 2000 May;117(5 Suppl 2):398S-401S. doi: 10.1378/chest.117.5_suppl_2.398s.
PubMed 10843984Sethi S, Murphy TF. Infection in the pathogenesis and course of chronic obstructive pulmonary disease. N Engl J Med. 2008 Nov 27;359(22):2355-65. doi: 10.1056/NEJMra0800353. No abstract available.
PubMed 19038881Momanyi L, Opanga S, Nyamu D, Oluka M, Kurdi A, Godman B. Antibiotic Prescribing Patterns at a Leading Referral Hospital in Kenya: A Point Prevalence Survey. J Res Pharm Pract. 2019 Oct 16;8(3):149-154. doi: 10.4103/jrpp.JRPP_18_68. eCollection 2019 Jul-Sep.
PubMed 31728346Slone DE, Ganjam VK, Purohit RC, Ravis WR. Cortisol (hydrocortisone) disappearance rate and pathophysiologic changes after bilateral adrenalectomy in equids. Am J Vet Res. 1983 Feb;44(2):276-9.
PubMed 6830017
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pattern of Micro-bacterial Infection and Its Sensitivity to Antibiotics in COPD Patients With Acute Exacerbation.
- ClinicalTrials.gov ID
- NCT06123780
- Acronym / sponsor ID
- Bacteriology in AECOPD
- Conditions
- Acute Exacerbation COPD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 9 Nov 2023 (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.
Measurement of bacterial species causing AECOPD and their Sensitivity pattern to antibiotics.
Detailed description
Chronic obstructive pulmonary disease (COPD) is a major cause of chronic morbidity and mortality worldwide.
Acute exacerbation is a common problem during the natural course of COPD, which is characterized by an increase in the patient's daily symptoms of dyspnea, cough, and/or sputum beyond normal day-to-day variability and severe enough to require an additional therapy.
The most common cause of acute exacerbations of COPD (AECOPD) is an infection of the tracheobronchial tree and air pollution. As many as one-third of AECOPD causes are never identified. The microbial aetiology of AECOPD includes bacteria and viruses with more than 50% of cases being caused by bacterial infection.
The bacterial etiologies of AECOPD keep changing from time to time and the choice of antimicrobial depends upon on local prevalence of bacterial etiologies and their resistance pattern.
Antibiotics are the main form of treatment for AECOPD which are often initiated empirically based on healthcare provider's previous experiences , which often lead to the inappropriate use of antibiotics , thereby contributing to Antimicrobial Resistance.
Early diagnosis and knowledge of the predominant bacterial etiologies and antimicrobial resistance patterns will also help to correct treatment protocol for the management of AECOPD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Demographic characteristics of these patients will be recorded, including sex, age, smoking status, underlying comorbidities, occupation and number of exacerbations. Clinical features will be recorded including increase grade of dyspnea , purulence and amount of sputum , history of previous NIV or MV. Spirometry as a confirmation tool of COPD. Arterial blood gases on admission. Complete blood count ( CBC ) and ESR Radiological profile of COPD patients. Sputum sample ; Spontaneous sputum sample by asking the patient to cough up sputum into sterile container. NIV patients : by spontaneous sputum sample. MV patients : by sputum suction through the endotracheal tube .
Key inclusion criteria (4 listed)
- Must be at least 18 years of age and less than 80 years of age for both genders
- Confirmed diagnosis of COPD by spirometry
- Must be an AECOPD patient (with increased grade of dyspnea, increased purulence and amount of sputum) and admitted to the chest department or ICU
- Positive sputum culture
Key exclusion criteria (2 listed)
- Age less than 18 years old
- Any associated pulmonary co-morbidity
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
Pattern of Microbial infection based on sputum culture results.
Time frame: Baseline
Identification of causative Microbial organisms of AECOPD based on results of sputum culture.
Pattern of antimicrobial sensitivities based on sputum culture results.
Time frame: Baseline
Identification of antimicrobial sensitivities and resistance patterns in this population based on results of sputum culture.
1 secondary outcome
Hospital length of stay
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Background: PubMed 34942084Venkatesan P. GOLD report: 2022 update. Lancet Respir Med. 2022 Feb;10(2):e20. doi: 10.1016/S2213-2600(21)00561-0. Epub 2021 Dec 20. No abstract available.
- Background: PubMed 10843984Rodriguez-Roisin R. Toward a consensus definition for COPD exacerbations. Chest. 2000 May;117(5 Suppl 2):398S-401S. doi: 10.1378/chest.117.5_suppl_2.398s.
- Background: PubMed 19038881Sethi S, Murphy TF. Infection in the pathogenesis and course of chronic obstructive pulmonary disease. N Engl J Med. 2008 Nov 27;359(22):2355-65. doi: 10.1056/NEJMra0800353. No abstract available.
- Background: PubMed 31728346Momanyi L, Opanga S, Nyamu D, Oluka M, Kurdi A, Godman B. Antibiotic Prescribing Patterns at a Leading Referral Hospital in Kenya: A Point Prevalence Survey. J Res Pharm Pract. 2019 Oct 16;8(3):149-154. doi: 10.4103/jrpp.JRPP_18_68. eCollection 2019 Jul-Sep.
- Background: PubMed 6830017Slone DE, Ganjam VK, Purohit RC, Ravis WR. Cortisol (hydrocortisone) disappearance rate and pathophysiologic changes after bilateral adrenalectomy in equids. Am J Vet Res. 1983 Feb;44(2):276-9.
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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.
Ahmed H Mohammed, Professor contact
Khaled H. Ahmed, Professor study director
Assuit U
Samiaa H Sadek, Professor study director
Assuit U
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Exacerbation COPD, run by Assiut University.
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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mariam Nazif Abdel-Tawab, MD (1228168408, marmar.mera69@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pattern of Microbial infection based on sputum culture results. (time frame: Baseline). The study lists 2 primary outcomes in all. 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 NCT06123780, which also lists 5 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 22 Nov 2023.