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Completed

NCT Number: NCT01892488

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

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).

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Key information

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Universitätsklinikum Aachen, Aachen, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: aminopenicillin + betalactamase inhibitor

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

Other names: Placebo: Lactose pill

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hannover Medical School

Other

Collaborators

  • Capnetz Stiftung

Registry information

Official study title

Randomized Double Blind Placebo-controlled Study to Demonstrate That Antibiotics Are Not Needed in Moderate Acute Exacerbations of COPD - The ABACOPD Study

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Jul 4, 2013
Registry last updated
Jun 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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