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

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ClinicalTrials.gov Identifier: NCT01892488
Recruitment Status : Completed
First Posted : July 4, 2013
Last Update Posted : October 15, 2019
Sponsor:
Collaborator:
CAPNETZ Stiftung
Information provided by (Responsible Party):
Tobias Welte, Hannover Medical School

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).

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease (COPD) Drug: Sultamicillin Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 295 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Double Blind Placebo-controlled Study to Demonstrate That Antibiotics Are Not Needed in Moderate Acute Exacerbations of COPD - The ABACOPD Study
Actual Study Start Date : June 7, 2013
Actual Primary Completion Date : April 23, 2019
Actual Study Completion Date : June 5, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
Placebo Comparator: lactose pill
Placebo for 5 days as supplement to standard of care for patients with AE-COPD
Drug: Placebo

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

Other Name: Placebo: Lactose pill

Experimental: Sultamicillin
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

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.

Other Name: aminopenicillin + betalactamase inhibitor




Primary Outcome Measures :
  1. Additional antibiotic therapy to study medication during treatment period or until the test of cure visit (at day 30) [ Time Frame: up to 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.



Secondary Outcome Measures :
  1. To evaluate long-term consequences of Placebo treatment [ Time Frame: up to 1 year ]
    • Relapse rate
    • Time to relapse

  2. To assess patient's clinical improvement relative to treatment [ Time Frame: up to 30 days ]
    • Clinical cure rate at the "end of therapy visit" (at day 6)
    • Clinical cure rate at the "test Of cure visit" (at day 30) (both determined by patient-centered outcomes (diary cards))

  3. To assess additional efficacy endpoints and health outcome evaluations [ Time Frame: up to 1 year ]
    • Changes in COPD Assessment Test(CAT)
    • Changes in Exacerbations of Chronic Pulmonary Disease Tool-Patient reported outcome (EXACT-PRO)
    • Additional antibiotic therapy
    • Time to next exacerbation
    • Number of exacerbations during follow up
    • Per-subject relapse rate at the LFU (Late Follow Up) visits in the subset of subjects in the CE population who were clinically cured at the TOC visit
    • Changes in length of stay in hospital for hospitalized patients
    • All cause mortality


Other Outcome Measures:
  1. Assessment of safety: [ Time Frame: up to 1 year ]

    Key criteria for safety are:

    adverse events, serious adverse events, changes in physical examination, vital signs, laboratory tests




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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.
  • Patients must sign and date an informed consent prior to any study procedures.

Exclusion Criteria:

  • 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
  • Lymphatic leukemia
  • Severe gastro-intestinal disorders with vomiting and diarrhea
  • Women who are breast feeding
  • Patients who have received treatment with any other investigational drug within 1 month prior to study entry, or have such treatment planned for the study period during treatment and follow up phase.
  • Patients with mental conditions rendering them unable to understand the nature, scope, and possible consequences of the study.
  • Patients unlikely to comply with the protocol, e.g., uncooperative attitude, inability to return for follow up visits, and unlikelihood of completing the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01892488


Locations
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Germany
Universitätsklinikum Aachen
Aachen, Germany
HELIOS Klinikum Emil von Behring Berlin
Berlin, Germany
Universitätsklinikum Dresden
Dresden, Germany
Universitätsmedizin Greifswald
Greifswald, Germany
Medizinische Hochschule Hannover
Hannover, Germany
Lungenfachklinik Immenhausen
Immenhausen, Germany
Universitätsklinikum Jena
Jena, Germany
Universitätsklinikum Schleswig-Holstein Campus Lübeck
Lübeck, Germany
Brüderkrankenhaus St. Josef Paderborn
Paderborn, Germany
Diakoniekrankenhaus Rotenburg
Rotenburg, Germany
Krankenhaus Bethanien Solingen
Solingen, Germany
Sponsors and Collaborators
Hannover Medical School
CAPNETZ Stiftung
Investigators
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Study Director: Gernot Rohde, Prof. Dr. CAPNETZ Stiftung
Principal Investigator: Tobias Welte, Prof.Dr. Hannover Medical School

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Tobias Welte, Prof. Dr., Hannover Medical School
ClinicalTrials.gov Identifier: NCT01892488     History of Changes
Other Study ID Numbers: Protocol-Code: 002/2012
2012-003234-16 ( EudraCT Number )
First Posted: July 4, 2013    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: October 2019
Keywords provided by Tobias Welte, Hannover Medical School:
COPD
AE-COPD
Chronic obstructive pulmonary disease
acute exacerbations of Chronic obstructive pulmonary disease
Additional relevant MeSH terms:
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Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Lung Diseases, Obstructive
Respiratory Tract Diseases
Sultamicillin
Ampicillin
Sulbactam
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action