Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02067780 |
| Other study ID # |
COPD levofloxacine Study |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 3
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 2017 |
| Est. completion date |
January 31, 2019 |
Study information
| Verified date |
November 2020 |
| Source |
University of Monastir |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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 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.
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:
1. 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.
2. 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.
