Chronic Obstructive Pulmonary DiseasePhase 2AECOPDNCT03698682
Short Compared With Standard Duration of Antibiotic Treatment for AECOPD
A Phase 2 study testing Levofloxacin 500mg in people with Chronic Obstructive Pulmonary Disease, run by University of Monastir at 1 site in Tunisia.
Trial summary
Chronic obstructive pulmonary disease (COPD) is one of the most common diseases in the world. Acute exacerbation of COPD (AECOPD) refers to an exaggeration of the symptoms of the disease. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Levofloxacin 500mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 310 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Jan 2018to 31 Jan 2021
- Phase
- Phase 2
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 45 years or older; had a smoking history of at least 10 pack-years; had a clinical diagnosis of mild-to-severe COPD, defined as a postbronchodilator forced expiratory volume in 1 s (FEV1 ) to forced vital capacity ratio of 0·7 or lower and a postbronchodilator FEV1 of at least 30%, according to Global Initiative of Chronic Obstructive Lung Disease (GOLD).
Who cannot join
- Patients were excluded if they presented one of the following conditions: clinical evidence of hemodynamic compromise with need to vasoactive drugs, Glasgow coma scale \<7.20, pneumonia, previous adverse reactions to study drug, antibiotic treatment in the previous days, pregnancy or lactation, severe renal (creatinineclearance 40 mL/min) or hepatic impairment, or lung disease other than COPD that couldaffect the clinical evaluation of the treatments. Patients with active alcohol or drug abuse were also excluded.
Trial locations and contacts
1 site in 1 country.
Tunisia1 site
Emergency department of university hospital Fattouma Bourguiba of Monastir
Monastir, 5000
About this study
Official title: Evaluation of Two Strategies of Antibiotic Treatment With Levofloxacin in Acute Exacerbation of Chronic Obstructive Pulmonary Disease: Short Treatment-versus Standard Treatment
Chronic obstructive pulmonary disease (COPD) is one of the most common diseases in the world. Acute exacerbation of COPD (AECOPD) refers to an exaggeration of the symptoms of the disease. Currently, the 3 Anthonisen criteria appear to be most satisfactory in defining the AECOPD: The increase in the volume of sputum, the alteration of its appearance which becomes purulent and The increase in dyspnea. Our recent study, showed that administration of levofloxacin is superior to placebo in the treatment of AECOPD; it is accompanied by a substantial reduction in mortality and a significant reduction in the residence time in hospital.The choice of antibiotic to be used in this situation is challenging to the clinician who must choose between traditional antibiotics (cyclins, aminopenicillins, cotrimoxazole...) and new antimicrobial agents. Antibiotic treatment duration was not based on a strong scientific rationale. Yet at the time of the dramatic emergence of bacterial resistance, reducing the selection pressure by reducing the exposure to antibiotic should be a major issue. In addition, the decrease in costs and associated side effects reinforces the interest of short treatments.
Unfortunately, few studies with a satisfactory methodology are available in the literature. In fact, we present the rational and the interest in shortening the durations of antibiotic treatment of AECOPD by levofloxacin in patients admitted to the emergency for exacerbation of COPD and to study the epidemiology of viral and bacterial AECOPD.
Read the detailed description
This study is a randomized prospective double-blind, accomplished with sealed envelopes ,with two groups :
- Group A: Short treatment duration: 1 tablet Levofloxacin 500mg / day for two days completed by 1 tablet Placebo Levofloxacin 500mg / day for the remaining 5 days.
- Group B: Standard treatment duration (control group): 1 tablet Levofloxacin 500mg / day for 7 days.
The study is conducted by recruiting AECOPD patients to collect their blood samples and sputum samples. These samples will be used for the inflammatory analyses and the study of bacterial and viral serology. The results were seized by the SPSS.20.0 software.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Levofloxacin 500mg
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levofloxacin 500mgDrug
Also called Placebo Levofloxacin 500mg
One tablet per day for 7 days.
| Study group | Role | What they receive |
|---|---|---|
| Short treatment group | Experimental | 1 tablet Levofloxacin 500mg / day for two days completed by 1 tablet Placebo Levofloxacin 500mg / day for 5 days. Receives: Drug: Levofloxacin 500mg |
| Standard treatment group | Experimental | 1 tablet of Levofloxacin 500mg prescribed for 7days Receives: Drug: Levofloxacin 500mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical cure rate
resolution of acute signs and symptoms of the exacerbation to baseline level (non-exacerbated state), together resolution of fever if present at study entry and no recurrences nor relapse at 30 days of follow-up.
Measured: 30 days after inclusion
Secondary outcomes (5)
Need for additional antibiotics
Patient requiring additional antibiotics. The decision to initiate new antibiotics was left to the discretion of the treating physician.
Measured: 30 days after inclusion
ICU admission rate
Patient requiring admission in an Intensive Care Unit for respiratory deterioration
Measured: 30 days after inclusion
Exacerbation Free Interval (EFI)
The period of time duringwhich the patient is not in exacerbation. It's the period of time between two exacerbations.
Measured: 30 days after inclusion
Number of reexacerbation at 12 months
Number of patients readmitted for exacerbation during the 12 months following inclusion
Measured: Up to 12 months pas inclusion
death rate at 12 months
number of death at 12 months
Measured: Up to 12 months pas inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start1 Jan 2018
- Primary completion31 Jan 2021
- Study completion31 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 310 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
- Investigators
- Semir Nouira, Professor, Study director, Research Laboratory (LR12SP18) University of Monastir 5000 Tunisia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03698682
- Sponsor's protocol ID
- AECOPD levofloxacine Study
- Acronym
- AECOPD
- Status last verified
- Jul 2021
- First submitted
- 2 Oct 2018
- Last updated
- 16 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Two Strategies of Antibiotic Treatment With Levofloxacin in Acute Exacerbation of Chronic Obstructive Pulmonary Disease: Short Treatment-versus Standard Treatment
- ClinicalTrials.gov ID
- NCT03698682
- Acronym / sponsor ID
- AECOPD / AECOPD levofloxacine Study
- Conditions
- Chronic Obstructive Pulmonary Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 310 participants (actual)
- Lead sponsor
- University of MonastirUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 9 Oct 2018 (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 one of the most common diseases in the world. Acute exacerbation of COPD (AECOPD) refers to an exaggeration of the symptoms of the disease. Currently, the 3 Anthonisen criteria appear to be most satisfactory in defining the AECOPD: The increase in the volume of sputum, the alteration of its appearance which becomes purulent and The increase in dyspnea. Our recent study, showed that administration of levofloxacin is superior to placebo in the treatment of AECOPD; it is accompanied by a substantial reduction in mortality and a significant reduction in the residence time in hospital.The choice of antibiotic to be used in this situation is challenging to the clinician who must choose between traditional antibiotics (cyclins, aminopenicillins, cotrimoxazole...) and new antimicrobial agents. Antibiotic treatment duration was not based on a strong scientific rationale. Yet at the time of the dramatic emergence of bacterial resistance, reducing the selection pressure by reducing the exposure to antibiotic should be a major issue. In addition, the decrease in costs and associated side effects reinforces the interest of short treatments.
Unfortunately, few studies with a satisfactory methodology are available in the literature. In fact, we present the rational and the interest in shortening the durations of antibiotic treatment of AECOPD by levofloxacin in patients admitted to the emergency for exacerbation of COPD and to study the epidemiology of viral and bacterial AECOPD.
Detailed description
This study is a randomized prospective double-blind, accomplished with sealed envelopes ,with two groups :
- Group A: Short treatment duration: 1 tablet Levofloxacin 500mg / day for two days completed by 1 tablet Placebo Levofloxacin 500mg / day for the remaining 5 days.
- Group B: Standard treatment duration (control group): 1 tablet Levofloxacin 500mg / day for 7 days.
The study is conducted by recruiting AECOPD patients to collect their blood samples and sputum samples. These samples will be used for the inflammatory analyses and the study of bacterial and viral serology. The results were seized by the SPSS.20.0 software.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short treatment group | Experimental | Drug: Levofloxacin 500mg1 tablet Levofloxacin 500mg / day for two days completed by 1 tablet Placebo Levofloxacin 500mg / day for 5 days. |
| Standard treatment group | Experimental | Drug: Levofloxacin 500mg1 tablet of Levofloxacin 500mg prescribed for 7days |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 45 years or older; had a smoking history of at least 10 pack-years; had a clinical diagnosis of mild-to-severe COPD, defined as a postbronchodilator forced expiratory volume in 1 s (FEV1 ) to forced vital capacity ratio of 0·7 or lower and a postbronchodilator FEV1 of at least 30%, according to Global Initiative of Chronic Obstructive Lung Disease (GOLD).
Key exclusion criteria (1 listed)
- Patients were excluded if they presented one of the following conditions: clinical evidence of hemodynamic compromise with need to vasoactive drugs, Glasgow coma scale \<7.20, pneumonia, previous adverse reactions to study drug, antibiotic treatment in the previous days, pregnancy or lactation, severe renal (creatinineclearance 40 mL/min) or hepatic impairment, or lung disease other than COPD that couldaffect the clinical evaluation of the treatments. Patients with active alcohol or drug abuse were also excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Levofloxacin 500mgAlso: Placebo Levofloxacin 500mgOne tablet per day for 7 days. | Drug | Short treatment group, Standard treatment group |
Primary outcome
Clinical cure rate
Time frame: 30 days after inclusion
resolution of acute signs and symptoms of the exacerbation to baseline level (non-exacerbated state), together resolution of fever if present at study entry and no recurrences nor relapse at 30 days of follow-up.
5 secondary outcomes
Need for additional antibiotics
Time frame: 30 days after inclusion
ICU admission rate
Time frame: 30 days after inclusion
Exacerbation Free Interval (EFI)
Time frame: 30 days after inclusion
Number of reexacerbation at 12 months
Time frame: Up to 12 months pas inclusion
death rate at 12 months
Time frame: Up to 12 months pas inclusion
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 16 Jul 2021.
- officiel siteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Semir Nouira, Professor study director
Research Laboratory (LR12SP18) University of Monastir 5000 Tunisia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Levofloxacin 500mg in people with Chronic Obstructive Pulmonary Disease, 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: finished, as of the sponsor's last update on 16 Jul 2021. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Clinical cure rate (time frame: 30 days after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jul 2021.