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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 : Unknown
Verified February 2017 by Tobias Welte, Hannover Medical School.
Recruitment status was:  Recruiting
First Posted : July 4, 2013
Last Update Posted : February 23, 2017
Sponsor:
Collaborator:
CAPNETZ Stiftung
Information provided by (Responsible Party):
Tobias Welte, Hannover Medical School

Tracking Information
First Submitted Date  ICMJE June 27, 2013
First Posted Date  ICMJE July 4, 2013
Last Update Posted Date February 23, 2017
Study Start Date  ICMJE June 2013
Estimated Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 1, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01892488 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 1, 2013)
  • To evaluate long-term consequences of Placebo treatment [ Time Frame: up to 1 year ]
    • Relapse rate
    • Time to relapse
  • 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))
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 1, 2013)
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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Study to Demonstrate That Antibiotics Are Not Needed in Moderate Acute Exacerbations of COPD
Official Title  ICMJE Randomized Double Blind Placebo-controlled Study to Demonstrate That Antibiotics Are Not Needed in Moderate Acute Exacerbations of COPD - The ABACOPD Study
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chronic Obstructive Pulmonary Disease (COPD)
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Placebo Comparator: lactose pill
    Placebo for 5 days as supplement to standard of care for patients with AE-COPD
    Intervention: Drug: Placebo
  • 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
    Intervention: Drug: Sultamicillin
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 1, 2013)
980
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2018
Estimated Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01892488
Other Study ID Numbers  ICMJE Protocol-Code: 002/2012
2012-003234-16 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tobias Welte, Hannover Medical School
Study Sponsor  ICMJE Hannover Medical School
Collaborators  ICMJE CAPNETZ Stiftung
Investigators  ICMJE
Study Director: Gernot Rohde, Prof. Dr. CAPNETZ Stiftung
Principal Investigator: Tobias Welte, Prof.Dr. Hannover Medical School
PRS Account Hannover Medical School
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP