COPD ExacerbationNCT05380375
Short-course Antibiotic Treatment in AECOPD: a Meta-analysis of Double-blind Studies
An observational study of COPD Exacerbation, run by University of Monastir at 1 site in Tunisia.
Trial summary
Chronic obstructive pulmonary disease (COPD) is a common disease worldwide and a leading cause of death and disability globally. Given that bacteria are implicated in a substantial proportion of acute exacerbation of COPD (AECOPD), antibiotics are frequently used. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COPD Exacerbation
- How many people
- 2 participants
- Where
- 1 siteTunisia
- Study dates
- 24 Feb 2022to 8 May 2023
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: We searched on the literature of controlled trials on Medline and Embase using the following search terms: COPD, antibiotic treatment and clinical trials. We also searched the reference lists of included studies for additional studies.
Who may be able to join
- Studies considered eligible for inclusion were randomised trials of antibiotic intervention involving adult patients >18 years of age with a diagnosis of AECOPD.
Who cannot join
- Studies not published in the English language or with more than two or different antibiotics were excluded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Short-course Versus Very Short-course Antibiotic Treatment in Acute Exacerbations of COPD: a Meta-analysis of Double-blind Studies
Chronic obstructive pulmonary disease (COPD) is a common disease worldwide and a leading cause of death and disability globally. Given that bacteria are implicated in a substantial proportion of acute exacerbation of COPD (AECOPD), antibiotics are frequently used. However, this current practice may lead to antibiotic overuse further increasing drug resistance and side effects. Although the small literature on interventions to prove the effective of short course of antibiotic, a metaanalysis of published randomised double-blind studies comparing the same antibiotics compared to a previous study is performed to determine whether a short course of antibiotic treatment is as effective as a very short course in patients with an exacerbation of COPD (EACOPD). The authors systematically searched electronic databases on the literature of controlled trials on Medline and Embase with no language, location, or time restrictions. The authors retrieved observational and controlled trials comparing different durations of the same oral antibiotic therapy in the treatment of acute exacerbations of COPD. The authors included 30 randomized, placebo-controlled trials for COPD patients. There was no statistically significant difference between shorter and longer antibiotic courses in early clinical success. In conclusion, Short-course antibiotic treatment is as effective as very short-course treatment in patients with mild to moderate exacerbations of chronic bronchitis and COPD.
- Conditions
- COPD Exacerbation
- Keywords
- AECOPD, antibiotic treatment, meta analysis, short course, Forest plot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Short-course | Group with short treatment of antibiotic of <= 5 days | |
| Very short-course | Group with short treatment of antibiotic of <= 3 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical success
clinical cure at early follow-up
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start24 Feb 2022
- Primary completion5 Mar 2023 (estimated)
- Study completion8 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPD ExacerbationStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Monastir
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pr. Semir Nouira, University of Monastir
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05380375
- Sponsor's protocol ID
- Meta analysis
- Status last verified
- Aug 2022
- First submitted
- 7 May 2022
- Last updated
- 17 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Messous S, Rekik A, Keraani L, Hamed R, Toumia M, Dhaoui R, Sekma A, Ali KBH, Sassi S, Kouraichi C, Boukef R, Bouida W, Boubaker H, Msolli MA, Nouira S. Comparative Efficacy and Safety of Short- Versus Standard-course Fluoroquinolone Treatment in Acute Exacerbations of Chronic Obstructive Pulmonary Disease: A Meta-analysis of Double-blind Studies. Clin Ther. 2025 Aug;47(8):631-637. doi: 10.1016/j.clinthera.2025.04.020. Epub 2025 May 25.
PubMed 40414751
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-course Versus Very Short-course Antibiotic Treatment in Acute Exacerbations of COPD: a Meta-analysis of Double-blind Studies
- ClinicalTrials.gov ID
- NCT05380375
- Acronym / sponsor ID
- Meta analysis
- Conditions
- COPD Exacerbation
- Keywords
- AECOPD, antibiotic treatment, meta analysis, short course, Forest plot
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of MonastirUniversity, hospital or other
- Study start
- 24 Feb 2022 (actual)
- Primary completion
- 5 Mar 2023 (estimated)
- Study completion
- 8 May 2023 (estimated)
- First posted
- 18 May 2022 (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.
Chronic obstructive pulmonary disease (COPD) is a common disease worldwide and a leading cause of death and disability globally. Given that bacteria are implicated in a substantial proportion of acute exacerbation of COPD (AECOPD), antibiotics are frequently used. However, this current practice may lead to antibiotic overuse further increasing drug resistance and side effects. Although the small literature on interventions to prove the effective of short course of antibiotic, a metaanalysis of published randomised double-blind studies comparing the same antibiotics compared to a previous study is performed to determine whether a short course of antibiotic treatment is as effective as a very short course in patients with an exacerbation of COPD (EACOPD). The authors systematically searched electronic databases on the literature of controlled trials on Medline and Embase with no language, location, or time restrictions. The authors retrieved observational and controlled trials comparing different durations of the same oral antibiotic therapy in the treatment of acute exacerbations of COPD. The authors included 30 randomized, placebo-controlled trials for COPD patients. There was no statistically significant difference between shorter and longer antibiotic courses in early clinical success. In conclusion, Short-course antibiotic treatment is as effective as very short-course treatment in patients with mild to moderate exacerbations of chronic bronchitis and COPD.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short-course | – | –Group with short treatment of antibiotic of <= 5 days |
| Very short-course | – | –Group with short treatment of antibiotic of <= 3 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- We searched on the literature of controlled trials on Medline and Embase using the following search terms: COPD, antibiotic treatment and clinical trials. We also searched the reference lists of included studies for additional studies.
Key inclusion criteria (1 listed)
- Studies considered eligible for inclusion were randomised trials of antibiotic intervention involving adult patients >18 years of age with a diagnosis of AECOPD.
Key exclusion criteria (1 listed)
- Studies not published in the English language or with more than two or different antibiotics were excluded
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
Clinical success
Time frame: 30 days
clinical cure at early follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2022.
- Derived from this study: PubMed 40414751Messous S, Rekik A, Keraani L, Hamed R, Toumia M, Dhaoui R, Sekma A, Ali KBH, Sassi S, Kouraichi C, Boukef R, Bouida W, Boubaker H, Msolli MA, Nouira S. Comparative Efficacy and Safety of Short- Versus Standard-course Fluoroquinolone Treatment in Acute Exacerbations of Chronic Obstructive Pulmonary Disease: A Meta-analysis of Double-blind Studies. Clin Ther. 2025 Aug;47(8):631-637. doi: 10.1016/j.clinthera.2025.04.020. Epub 2025 May 25.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 COPD Exacerbation, run by University of Monastir at 1 site in Tunisia.
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 1 inclusion and 1 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 17 Aug 2022. 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 Tunisia. 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?
Results are not available in the source record.
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?
Clinical success (time frame: 30 days). 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 NCT05380375, which also lists 1 linked publication.
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 17 Aug 2022; AzTrials last refreshed its copy on 7 Nov 2026.