Short Antibiotic Treatment Versus Duration Guided by Markers of Inflammation in the Treatment of AECOPD

NCT02067780 | Completed Phase 3 DMC

• 1 other identifier: COPD levofloxacine Study
• Study Type: interventional
• Target: 310
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• cure rate

  By hospital Data and telephonic calling.

  1 year after starting protocol

Secondary Outcomes (4)

• Rate of additional antibiotherapy course

  one week

• rate of admission in the intensive care unit

  one week

• exacerbation rate

  1 year after starting protocol

• exacerbation free interval

  1year after starting protocol

Study Arms (2)

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.

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.

Drug: Levofloxacin 500mg

Interventions

Levofloxacin 500mg DRUG

One tablet per day for 7days.

Also known as: Placebo Levofloxacin 500mg

The intervention (CRP-guided) group; The standard care (control) group

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients having COPD (according to the definition of the American Thoracic Society) in acute exacerbation

You may not qualify if:

• 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,
• 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

Sponsors & Collaborators

• University of Monastir: lead

Study Sites (1)

Emergency department of university hospital Fattouma Bourguiba of Monastir

Monastir, 5000, Tunisia

Location

Related Links

• officiel site

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Levofloxacin

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Semir Nouira, professor

  Research Laboratory (LR12SP18) University of Monastir 5000 Tunisia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 11, 2014
• First Posted: February 20, 2014
• Study Start: May 1, 2017
• Primary Completion: January 31, 2019
• Study Completion: January 31, 2019
• Last Updated: November 10, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)