Study to Demonstrate That Antibiotics Are Not Needed in Moderate Acute Exacerbations of COPD

NCT01892488 | Completed Phase 4 DMC

• 2 other identifiers: Protocol-Code: 002/20122012-003234-16
• Study Type: interventional
• Target: 295
• Locations: 1 country
• Sites: 32

Brief Summary

The ultimate goal is to reduce unnecessary antibiotic prescriptions which drive the development of antibiotic resistance in the community. The primary objective of ABACOPD is to demonstrate in a sufficiently sized clinical study that there is no relevant increase in the "failure-rate" for patients with acute moderate exacerbations of COPD (AE-COPD) treated with placebo instead of antibiotic treatment both on top of standard of care. A patient is classified as treatment failure if additional antibiotic therapy is required during treatment period or until the test of cure visit (TOC at day 30, primary endpoint).

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

COPD; AE-COPD; Chronic obstructive pulmonary disease; acute exacerbations of Chronic obstructive pulmonary disease

Outcome Measures

Primary Outcomes (1)

• Additional antibiotic therapy to study medication during treatment period or until the test of cure visit (at day 30)

  Assessment of additional antibiotic therapy: Patients will be asked at every visit about use of additional antibiotic therapy. In the case of use of additional antibiotic therapy the exact starting date, the active compound, the dose administered, the route of administration,the length of treatment and the indication will be registered. Only additional antibiotic therapy for AE-COPD will be counted as treatment failure.

  up to day 30

Secondary Outcomes (3)

• To evaluate long-term consequences of Placebo treatment

  up to 1 year

• To assess patient's clinical improvement relative to treatment

  up to 30 days

• To assess additional efficacy endpoints and health outcome evaluations

  up to 1 year

Other Outcomes (1)

• Assessment of safety:

  up to 1 year

Study Arms (2)

lactose pill

PLACEBO COMPARATOR

Placebo for 5 days as supplement to standard of care for patients with AE-COPD

Drug: Placebo

Sultamicillin

EXPERIMENTAL

Antibiotic therapy with aminopenicillin + betalactamase inhibitor (oral Sultamicillin (2 x 750mg)) for 5 days as supplement to standard of care for patients with AE-COPD

Drug: Sultamicillin

Interventions

Sultamicillin DRUG

Standard of care: Each patient will receive inhaled fast-acting bronchodilators (up to a maximum of 4 - 6 times daily 2 puffs (100µg) of salbutamol or other equivalent inhaled fast-acting bronchodilators), systemic corticosteroids (prednisolone 40mg/d p.o. for 7 - 10 days) and oxygen in case of hypoxemia in a standardized fashion. The pre-existing COPD medication will be continued as indicated. Experimental intervention: Antibiotic therapy with aminopenicillin + betalactamase inhibitor (oral Sultamicillin (2 x 750mg)) for 5 days as supplement to standard of care for patients with AE-COPD.

Also known as: aminopenicillin + betalactamase inhibitor

Sultamicillin

Placebo DRUG

Standard of care: Each patient will receive inhaled fast-acting bronchodilators (up to a maximum of 4 - 6 times daily 2 puffs (100µg) of salbutamol or other equivalent inhaled fast-acting bronchodilators), systemic corticosteroids (prednisolone 40mg/d p.o. for 7 - 10 days) and oxygen in case of hypoxemia in a standardized fashion. The pre-existing COPD medication will be continued as indicated. Control intervention: Placebo for 5 days as supplement to standard of care for patients with AE-COPD

Also known as: Placebo: Lactose pill

lactose pill

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults, either sex, older or equal than 40 years of age
• For female patients, the following conditions are to be met:
• has been postmenopausal for at least 1 year, or
• is surgically incapable of bearing children, or
• is of childbearing potential, and the following conditions are met:
• has a negative pregnancy test (urine- or serum-based) immediately before study entry (i.e., before the start of treatment or any other study procedure that could potentially harm the fetus), and one or more of following criteria
• must agree to abstinence or use an accepted method of contraception. The subject must agree to continue with the same method throughout the study.
• having only female sexual partners
• sexual relationship with sterile male partners only
• Patients diagnosed with COPD stages I-IV as defined by the Global initiative for chronic Obstructive Lung disease (GOLD).
• and
• Doctor's diagnosis of acute (onset \< 7 days) moderate exacerbation of COPD defined by a sustained worsening of the patient's condition (including at least 2 of the following symptoms: increased dyspnea, increased sputum production, sputum purulence and increased cough), from the stable state and beyond normal day-to-day variations, necessitating a change in regular medication in patient with underlying COPD, needing additional medical assistance.
• Absence of community acquired pneumonia or lower respiratory tract infection with a clear indication for antibiotic treatment as determined by Procalcitonin level \< 0.25 ng/mL and/or absence of pulmonary infiltrates on routine chest x-ray.
• Smoking history of at least 10 Pack Years or more.
• Patients must be able to complete diaries and quality of life questionnaires.

You may not qualify if:

• Severe exacerbation: defined by need for ventilatory support (indicated by severe dyspnea with failure to respond to emergency treatment and/or persistent hypoxemia (PaO2 \<50 mm Hg despite O2 administration and / or respiratory acidosis (pH \<7.35 and PaCO2\> 45mmHg)) or mental confusion or circulatory insufficiency (need of vasopressors)
• Fever (\>38.5°C)
• Known impaired hepatic or renal function
• Active or suspected tuberculosis infection of the respiratory tract
• Acute exacerbation of asthma
• Suspected or known hypersensitivity to, or suspected serious adverse reaction to sultamicillin; suspected or known hypersensitivity to penicillins or cephalosporins
• Immunosuppression or Immunosuppressive therapy (cytostatic chemotherapy within last 28 days or neutropenia (neutrophils \< 1000/µ)l; systemic corticosteroids (≥20 mg prednisolon equivalent/day \> 14 days; HIV-infection; immunosuppression after organ- or bone marrow transplant)- Patients with metastatic or hematological malignancy, splenectomized patients or patients with known hyposplenia or asplenia
• Oral/parenteral antibiotic use within 30 days prior to randomization (a singular administration of antibiotics prior to randomization is allowed)
• In-patient treatment within the last 30 days
• An antibiotic is clearly indicated for treatment of a known infection
• Known MRSA (methicillin-resistant Staphylococcus aureus) colonization or infection
• Patients with known bronchiectasis
• Patients with known bacterial airway colonization (\>3 positive sputum cultures in the previous year)
• Progressively fatal disease, or life expectancy ≤6 months
• Mononucleosis

Sponsors & Collaborators

• Hannover Medical School: lead
• CAPNETZ Stiftung: collaborator

Study Sites (32)

Universitätsklinikum Aachen

Aachen, Germany

Location

Krankenhaus Bad Arolsen

Bad Arolsen, Germany

Location

Lungenklinik Ballenstedt

Ballenstedt, Germany

Location

Charité - Universitätsmedizin Berlin

Berlin, Germany

Location

HELIOS Klinikum Emil von Behring Berlin

Berlin, Germany

Location

Pneumologische Praxis am Schloss Charlottenburg Berlin

Berlin, Germany

Location

Vivantes Klinikum Neukölln

Berlin, Germany

Location

Vivantes Klinikum Spandau

Berlin, Germany

Location

Klinikum der Ruhr-Universität Bochum

Bochum, Germany

Location

Pneumologische Gemeinschaftspraxis Bonn

Bonn, Germany

Location

Forschungszentrum Borstel

Borstel, Germany

Location

Klinikum Dortmund gGmbH

Dortmund, Germany

Location

Universitätsklinikum Dresden

Dresden, Germany

Location

Pneumologische Klinik Waldhof Elgershausen

Elgershausen, Germany

Location

Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH

Essen, Germany

Location

Praxis Dr. med. Ina Itzigehl Euskirchen

Euskirchen, Germany

Location

Universitätsklinikum Freiburg

Freiburg im Breisgau, Germany

Location

Universitätsmedizin Greifswald

Greifswald, Germany

Location

HELIOS Klinik Hagen-Ambrock

Hagen, Germany

Location

Elbpneumologie Hamburg

Hamburg, Germany

Location

Schwerpunktpraxis Colonnaden Hamburg

Hamburg, Germany

Location

Medizinische Hochschule Hannover

Hanover, Germany

Location

Thoraxklinik am Universitätsklinikum Heidelberg

Heidelberg, Germany

Location

Universitätsklinikum Heidelberg

Heidelberg, Germany

Location

Lungenfachklinik Immenhausen

Immenhausen, Germany

Location

Universitätsklinikum Jena

Jena, Germany

Location

Universitätsklinikum Schleswig-Holstein Kiel

Kiel, Germany

Location

Universitätsklinikum Schleswig-Holstein Campus Lübeck

Lübeck, Germany

Location

Brüderkrankenhaus St. Josef Paderborn

Paderborn, Germany

Location

Diakoniekrankenhaus Rotenburg

Rotenburg (Wümme), Germany

Location

Krankenhaus Bethanien Solingen

Solingen, Germany

Location

HELIOS Klinikum Wuppertal-Barmen

Wuppertal, Germany

Location

Related Publications (1)

• Rohde GG, Koch A, Welte T; ABACOPD study group. Randomized double blind placebo-controlled study to demonstrate that antibiotics are not needed in moderate acute exacerbations of COPD--the ABACOPD study. BMC Pulm Med. 2015 Jan 27;15:5. doi: 10.1186/1471-2466-15-5.

  PMID: 25623589 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

sultamicillin

Condition Hierarchy (Ancestors)

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

Study Officials

• Gernot Rohde, Prof. Dr.

  CAPNETZ Stiftung

  STUDY DIRECTOR

• Tobias Welte, Prof.Dr.

  Hannover Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: June 27, 2013
• First Posted: July 4, 2013
• Study Start: June 7, 2013
• Primary Completion: April 23, 2019
• Study Completion: June 5, 2019
• Last Updated: June 5, 2020

Record last verified: 2020-06

Locations

DE (32)