Azithromycine during and after the acute hospital admission for acute exacerbation of chronic obstructive pulmonary disease

Azithromycin for acute COPD exacerbations with hospitalisation: the BACE trial - BACE

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-004420-11-BE

Enrollment

500

Registered

2014-02-13

Start date

2014-04-29

Completion date

Unknown

Last updated

2019-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute COPD exacerbations with hospitalisation. MedDRA version: 18.0 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 100000004855 MedDRA version: 18.0 Level: LLT Classification code 10010953 Term: COPD exacerbation System Organ Class: 100000004855

Interventions

Trade Name: Azitromycine CF Product Name: Azitromycine CF Pharmaceutical Form: Tablet INN or Proposed INN: Azithromycin CAS Number: 1214

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1/ Established diagnosis of COPD by medical doctor (based on clinical history OR pulmonary function test) 2/ Smoking history (= 10 pack-years) 3/ Current hospitalization for potential infectious AECOPD treated with standard therapy 4/ History of at least one exacerbation during the last year for which systemic steroids and/or antibiotics were taken 5/ ECG at admission Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 300

Exclusion criteria

Exclusion criteria: 1/ Mechanical or non-invasive ventilation at moment of randomisation (D1) 2/ Long QT interval on ECG (QTc > 450msec for males or > 470msec for females) 3/ History of life-threatening arrhythmias 4/ Myocardial infarction (NSTEMI or STEMI) less than 6 weeks before of start study 5/ Unstable angina pectoris or acute myocardial infarction (NSTEMI or STEMI) at admission 6/ Drugs with high risk for long QT interval and torsade de pointes (amiodarone, flecainide, procainamide, sotalol, droperidol, haldol, citalopram, other macrolides). 7/ Documented uncorrected severe hypokalemia (K+ 4 mg methylprednisolone /day for = 2 months) 9/ Actual use of macrolides for at least 2 weeks 10/ Allergy to macrolides 11/ Active cancer treatment 12/ Life expectancy < 3 months 13/ Pregnant or breast-feeding women

Design outcomes

Secondary

Measure	Time frame
Secondary end point(s): Secondary endpoints of the study will include number of treatment failures, time to new exacerbation, number of exacerbations, total days of hospitalization, total days of intensive care, total days of antibiotics, total dose of systemic steroids but also FEV1 and self-administered symptom or quality of life scores (EQ5D, CCQ, CAT, SSQ5). ;Timepoint(s) of evaluation of this end point: The secondary endpoints of the study will be evaluated at discharge, after 3 months and 9 months.	—

Measure

Time frame

Secondary end point(s): Secondary endpoints of the study will include number of treatment failures, time to new exacerbation, number of exacerbations, total days of hospitalization, total days of intensive care, total days of antibiotics, total dose of systemic steroids but also FEV1 and self-administered symptom or quality of life scores (EQ5D, CCQ, CAT, SSQ5). ;Timepoint(s) of evaluation of this end point: The secondary endpoints of the study will be evaluated at discharge, after 3 months and 9 months.

—

Primary

Measure	Time frame
Main Objective: The first objective is to proof the effectiveness of azithromycin on top of standard therapy in the acute treatment of COPD exacerbations which require hospitalization. ;Secondary Objective: A second objective is to proof and improve safety without losing effectiveness by reducing dose and duration of a current everlasting treatment. ;Primary end point(s): The primary endpoint is time to treatment failure.;Timepoint(s) of evaluation of this end point: The primary endpoint will be evaluated after 3 months, which is also the day that all study medication will be stopped.	—

Measure

Time frame

Main Objective: The first objective is to proof the effectiveness of azithromycin on top of standard therapy in the acute treatment of COPD exacerbations which require hospitalization. ;Secondary Objective: A second objective is to proof and improve safety without losing effectiveness by reducing dose and duration of a current everlasting treatment. ;Primary end point(s): The primary endpoint is time to treatment failure.;Timepoint(s) of evaluation of this end point: The primary endpoint will be evaluated after 3 months, which is also the day that all study medication will be stopped.

—

Countries

Belgium

Contacts

Public ContactKristina Vermeersch

KU Leuven - UZ Leuven

kristina.vermeersch@uzleuven.be0032016342284

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026