Chronic Obstructive Pulmonary DiseasePhase 3AECOPDNCT02067780
Short Antibiotic Treatment Versus Duration Guided by Markers of Inflammation in the Treatment of AECOPD
A Phase 3 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. In a recent study, we showed that administration of levofloxacin is superior to placebo in the treatment of decompensation of COPD; it is accompanied by a substantial reduction in mortality and a significant reduction in the… 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 May 2017to 31 Jan 2019
- Phase
- Phase 3
- 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
- patients having COPD (according to the definition of the American Thoracic Society) in acute exacerbation
Who cannot join
- clinical evidence of hemodynamic compromise with the need for vasoactive drugs
- immediate need for mechanical ventilation,
- Glasgow Coma scale <12,
- pneumonia,
- previous adverse reactions to the study drug,
- antibiotic treatment in the previous days,
Show all 9Show fewer
- pregnancy or lactation,
- severe renal (creatinine clearance 40 mL/min) or hepatic impairment,
- lung disease other than COPD that could affect the clinical evaluation of the treatments. --active alcohol or drug abuse
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 Treatment Guided by Markers of Inflammation
Chronic obstructive pulmonary disease (COPD) is one of the most common diseases in the world. In a recent study, we showed that administration of levofloxacin is superior to placebo in the treatment of decompensation of COPD; it is accompanied by a substantial reduction in mortality and a significant reduction in the residence time in hospital.
In Tunisia, few data are available on the epidemiology of COPD decompensation. 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. Recently, it has been emphasized the selection of patients for treatment according to the degree of systemic inflammation (C-Reactive Protein). Indeed, there would have a correlation between the tracheobronchial infection and elevated inflammatory markers. As the elevation of these markers is proportional to the intensity of the inflammatory reaction of the body, is based on the kinetics of these biomarkers in antibiotic treatment seems logical. Thus, C-Reactive Protein allowed not only knowing when to start antibiotics, but also through their kinetic, these markers can guide the duration of therapy and shorten the duration of antibiotic therapy: a rate cut would ensure that the antibiotic treatment was adopted. Available guidelines stated that antibiotic treatment should be maintained at an average of 7 to 10 days while some studies showed no clinical inferiority of courses as short as 3 days. Further reduction of the duration of antibiotherapy was even suggested in order to reduce the risk of adverse events and the pressure that drives bacterial resistance. Hence, we conducted this study using an algorithm to comprehensively evaluate the role of CRP-guided antibiotic prescription in optimizing treatment duration in AECOPD.
Read the detailed description
This study is a prospective, randomized, double blind controlled study including patients admitted to the emergency department (ED) with AECOPD. Patients were randomly assigned (1:1) to receive treatment either according to guidance based on serum CRP level (CRP-guided group) or the standard of care (control group). The randomisation sequence was generated using the sealed envelope sequence generator stratified according to investigator site. Online inclusion of patients according to the concealed sequence was done with an independent, centralised web-based system (DACIMA Tunisia; https://www.dacimasoftware.com).
Patients were assigned to one of the two treatment arms:
- the intervention (CRP-guided) group: 500 mg (one tablet) of oral levofloxacin daily of levofloxacin for 7 days unless the serum CRP decrease by at least 50% from baseline value. Measurements of serum CRP were done at ED admission, at day-2, day-4 and day-6 and made available to the attending physicians.
- the standard care (control) group: 500 mg of levofloxacin per day for the first two days. Thereafter, oral tablet of placebo was prescribed according to CRP values as in CRP guided group to keep the blindness of the study. Also, in order to ensure blinding, active drug as well as placebo tablets were encapsulated for identical appearance and placed in sealed envelopes.
The study is approved by ethics committees of all participating centers prior to implementation, and all included patients provided their written informed consent. The study was. The study protocol has been prepared in accordance with the revised Helsinki Declaration for Biomedical Research Involving Human Subjects and Guidelines for Good Clinical Practice.
After verification of inclusion and exclusion criteria as well the informed consent, demographic, clinical and biological data were collected at baseline. These included patient comorbidities, number of exacerbations in the past year, physical examination findings, blood gas analysis, and standard laboratory tests results. Expectorated sputum samples were collected for pathogen culture. All data were recorded in standardized electronic case report forms. All statistical analyses were performed using SPSS software, version 20.0.
- 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 7days.
| Study group | Role | What they receive |
|---|---|---|
| The intervention (CRP-guided) group | Experimental | 500 mg (one tablet) of oral levofloxacin daily of levofloxacin for 7 days unless the serum CRP decrease by at least 50% from baseline value. Measurements of serum CRP were done at ED admission, at day-2, day-4 and day-6 and made available to the attending physicians. Receives: Drug: Levofloxacin 500mg |
| The standard care (control) group | Experimental | 500 mg of levofloxacin per day for the first two days. Thereafter, oral tablet of placebo was prescribed according to CRP values as in CRP guided group to keep the blindness of the study. Receives: Drug: Levofloxacin 500mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
cure rate
By hospital Data and telephonic calling.
Measured: 1 year after starting protocol
Secondary outcomes (4)
Rate of additional antibiotherapy course
The frequency of additional antibiotherapy course indicated to treat COPD patients during the hospital stay.
Measured: one week
rate of admission in the intensive care unit
By hospital Data and telephonic calling.
Measured: one week
exacerbation rate
By hospital Data and telephonic calling.
Measured: 1 year after starting protocol
exacerbation free interval
rate of admission in the intensive care unit
Measured: 1year after starting protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2014 (estimated)
- Study start1 May 2017
- Primary completion31 Jan 2019
- Study completion31 Jan 2019
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 3
- 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
- NCT02067780
- Sponsor's protocol ID
- COPD levofloxacine Study
- Acronym
- AECOPD
- Status last verified
- Nov 2020
- First submitted
- 11 Feb 2014
- Last updated
- 10 Nov 2020
- 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 10 Nov 2020. 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 Treatment Guided by Markers of Inflammation
- ClinicalTrials.gov ID
- NCT02067780
- Acronym / sponsor ID
- AECOPD / COPD levofloxacine Study
- Conditions
- Chronic Obstructive Pulmonary Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 310 participants (actual)
- Lead sponsor
- University of MonastirUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 20 Feb 2014 (estimated)
- 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. In a recent study, we showed that administration of levofloxacin is superior to placebo in the treatment of decompensation of COPD; it is accompanied by a substantial reduction in mortality and a significant reduction in the residence time in hospital.
In Tunisia, few data are available on the epidemiology of COPD decompensation. 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. Recently, it has been emphasized the selection of patients for treatment according to the degree of systemic inflammation (C-Reactive Protein). Indeed, there would have a correlation between the tracheobronchial infection and elevated inflammatory markers. As the elevation of these markers is proportional to the intensity of the inflammatory reaction of the body, is based on the kinetics of these biomarkers in antibiotic treatment seems logical. Thus, C-Reactive Protein allowed not only knowing when to start antibiotics, but also through their kinetic, these markers can guide the duration of therapy and shorten the duration of antibiotic therapy: a rate cut would ensure that the antibiotic treatment was adopted. Available guidelines stated that antibiotic treatment should be maintained at an average of 7 to 10 days while some studies showed no clinical inferiority of courses as short as 3 days. Further reduction of the duration of antibiotherapy was even suggested in order to reduce the risk of adverse events and the pressure that drives bacterial resistance. Hence, we conducted this study using an algorithm to comprehensively evaluate the role of CRP-guided antibiotic prescription in optimizing treatment duration in AECOPD.
Detailed description
This study is a prospective, randomized, double blind controlled study including patients admitted to the emergency department (ED) with AECOPD. Patients were randomly assigned (1:1) to receive treatment either according to guidance based on serum CRP level (CRP-guided group) or the standard of care (control group). The randomisation sequence was generated using the sealed envelope sequence generator stratified according to investigator site. Online inclusion of patients according to the concealed sequence was done with an independent, centralised web-based system (DACIMA Tunisia; https://www.dacimasoftware.com).
Patients were assigned to one of the two treatment arms:
- the intervention (CRP-guided) group: 500 mg (one tablet) of oral levofloxacin daily of levofloxacin for 7 days unless the serum CRP decrease by at least 50% from baseline value. Measurements of serum CRP were done at ED admission, at day-2, day-4 and day-6 and made available to the attending physicians.
- the standard care (control) group: 500 mg of levofloxacin per day for the first two days. Thereafter, oral tablet of placebo was prescribed according to CRP values as in CRP guided group to keep the blindness of the study. Also, in order to ensure blinding, active drug as well as placebo tablets were encapsulated for identical appearance and placed in sealed envelopes.
The study is approved by ethics committees of all participating centers prior to implementation, and all included patients provided their written informed consent. The study was. The study protocol has been prepared in accordance with the revised Helsinki Declaration for Biomedical Research Involving Human Subjects and Guidelines for Good Clinical Practice.
After verification of inclusion and exclusion criteria as well the informed consent, demographic, clinical and biological data were collected at baseline. These included patient comorbidities, number of exacerbations in the past year, physical examination findings, blood gas analysis, and standard laboratory tests results. Expectorated sputum samples were collected for pathogen culture. All data were recorded in standardized electronic case report forms. All statistical analyses were performed using SPSS software, version 20.0.
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 |
|---|---|---|
| The intervention (CRP-guided) group | Experimental | Drug: Levofloxacin 500mg500 mg (one tablet) of oral levofloxacin daily of levofloxacin for 7 days unless the serum CRP decrease by at least 50% from baseline value. Measurements of serum CRP were done at ED admission, at day-2, day-4 and day-6 and made available to the attending physicians. |
| The standard care (control) group | Experimental | Drug: Levofloxacin 500mg500 mg of levofloxacin per day for the first two days. Thereafter, oral tablet of placebo was prescribed according to CRP values as in CRP guided group to keep the blindness of the study. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients having COPD (according to the definition of the American Thoracic Society) in acute exacerbation
Key exclusion criteria (9 listed)
- clinical evidence of hemodynamic compromise with the need for vasoactive drugs
- immediate need for mechanical ventilation,
- Glasgow Coma scale <12,
- pneumonia,
- previous adverse reactions to the study drug,
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 7days. | Drug | The intervention (CRP-guided) group, The standard care (control) group |
Primary outcome
cure rate
Time frame: 1 year after starting protocol
By hospital Data and telephonic calling.
4 secondary outcomes
Rate of additional antibiotherapy course
Time frame: one week
rate of admission in the intensive care unit
Time frame: one week
exacerbation rate
Time frame: 1 year after starting protocol
exacerbation free interval
Time frame: 1year after starting protocol
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 10 Nov 2020.
- 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 3 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 9 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 10 Nov 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 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
cure rate (time frame: 1 year after starting protocol). 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 10 Nov 2020.