Chronic Obstructive Pulmonary Disease (COPD)Phase 4NCT01892488
Study to Demonstrate That Antibiotics Are Not Needed in Moderate Acute Exacerbations of COPD
A Phase 4 study testing Sultamicillin in people with Chronic Obstructive Pulmonary Disease (COPD), run by Hannover Medical School at 32 sites in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Sultamicillin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 295 participants
- Where
- 32 sitesGermany
- Study dates
- 7 Jun 2013to 5 Jun 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
Germany32 sites
Universitätsklinikum Aachen
Aachen
Krankenhaus Bad Arolsen
Bad Arolsen
Lungenklinik Ballenstedt
Ballenstedt
Charité - Universitätsmedizin Berlin
Berlin
HELIOS Klinikum Emil von Behring Berlin
Berlin
Pneumologische Praxis am Schloss Charlottenburg Berlin
Berlin
Vivantes Klinikum Neukölln
Berlin
Vivantes Klinikum Spandau
Berlin
Klinikum der Ruhr-Universität Bochum
Bochum
Pneumologische Gemeinschaftspraxis Bonn
Bonn
Forschungszentrum Borstel
Borstel
Klinikum Dortmund gGmbH
Dortmund
Universitätsklinikum Dresden
Dresden
Pneumologische Klinik Waldhof Elgershausen
Elgershausen
Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
Essen
Praxis Dr. med. Ina Itzigehl Euskirchen
Euskirchen
Universitätsklinikum Freiburg
Freiburg im Breisgau
Universitätsmedizin Greifswald
Greifswald
HELIOS Klinik Hagen-Ambrock
Hagen
Elbpneumologie Hamburg
Hamburg
Schwerpunktpraxis Colonnaden Hamburg
Hamburg
Medizinische Hochschule Hannover
Hanover
Thoraxklinik am Universitätsklinikum Heidelberg
Heidelberg
Universitätsklinikum Heidelberg
Heidelberg
Lungenfachklinik Immenhausen
Immenhausen
Universitätsklinikum Jena
Jena
Universitätsklinikum Schleswig-Holstein Kiel
Kiel
Universitätsklinikum Schleswig-Holstein Campus Lübeck
Lübeck
Brüderkrankenhaus St. Josef Paderborn
Paderborn
Diakoniekrankenhaus Rotenburg
Rotenburg (Wümme)
Krankenhaus Bethanien Solingen
Solingen
HELIOS Klinikum Wuppertal-Barmen
Wuppertal
About this study
Official title: Randomized Double Blind Placebo-controlled Study to Demonstrate That Antibiotics Are Not Needed in Moderate Acute Exacerbations of COPD - The ABACOPD Study
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).
- Being tested
- Sultamicillin, Placebo
- Keywords
- COPD, AE-COPD, Chronic obstructive pulmonary disease, acute exacerbations of Chronic obstructive pulmonary disease
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SultamicillinDrug
Also called aminopenicillin + betalactamase inhibitor
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.
PlaceboDrug
Also called Placebo: Lactose pill
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
| Study group | Role | What they receive |
|---|---|---|
| lactose pill | Placebo comparator | Placebo for 5 days as supplement to standard of care for patients with AE-COPD Receives: 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 Receives: Drug: Sultamicillin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to day 30
Secondary outcomes (3)
To evaluate long-term consequences of Placebo treatment
- Relapse rate
- Time to relapse
Measured: up to 1 year
To assess patient's clinical improvement relative to treatment
- 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))
Measured: up to 30 days
To assess additional efficacy endpoints and health outcome evaluations
- 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
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2013 (estimated)
- Study start7 Jun 2013
- Primary completion23 Apr 2019
- Study completion5 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 295 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Capnetz Stiftung
- Responsible party
- Principal investigator, Tobias Welte, Hannover Medical School
- Investigators
- Gernot Rohde, Prof. Dr., Study director, Capnetz StiftungTobias Welte, Prof.Dr., Principal investigator, Hannover Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01892488
- Sponsor's protocol ID
- Protocol-Code: 002/2012
- Other IDs
- 2012-003234-16
- Status last verified
- Jun 2020
- First submitted
- 27 Jun 2013
- Last updated
- 5 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 25623589
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double Blind Placebo-controlled Study to Demonstrate That Antibiotics Are Not Needed in Moderate Acute Exacerbations of COPD - The ABACOPD Study
- ClinicalTrials.gov ID
- NCT01892488
- Acronym / sponsor ID
- Protocol-Code: 002/2012
- Keywords
- COPD, AE-COPD, Chronic obstructive pulmonary disease, acute exacerbations of Chronic obstructive pulmonary disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 295 participants (actual)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Collaborators
- Capnetz Stiftung
- Study start
- 7 Jun 2013 (actual)
- Primary completion
- 23 Apr 2019 (actual)
- Study completion
- 5 Jun 2019 (actual)
- First posted
- 4 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lactose pill | Placebo comparator | Drug: PlaceboPlacebo for 5 days as supplement to standard of care for patients with AE-COPD |
| Sultamicillin | Experimental | Drug: SultamicillinAntibiotic therapy with aminopenicillin + betalactamase inhibitor (oral Sultamicillin (2 x 750mg)) for 5 days as supplement to standard of care for patients with AE-COPD |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Adults, either sex, older or equal than 40 years of age
- For female patients, the following conditions are to be met:
- 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.
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SultamicillinAlso: aminopenicillin + betalactamase inhibitorStandard 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. | Drug | Sultamicillin |
| PlaceboAlso: Placebo: Lactose pillStandard 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 | Drug | lactose pill |
Primary outcome
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.
3 secondary outcomes
To evaluate long-term consequences of Placebo treatment
Time frame: up to 1 year
To assess patient's clinical improvement relative to treatment
Time frame: up to 30 days
To assess additional efficacy endpoints and health outcome evaluations
Time frame: up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2020.
- Derived from this study: PubMed 25623589Rohde 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.
- ABACOPD-HomepageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gernot Rohde, Prof. Dr. study director
Capnetz Stiftung
Tobias Welte, Prof.Dr. principal investigator
Hannover Medical School
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sultamicillin in people with Chronic Obstructive Pulmonary Disease (COPD), run by Hannover Medical School at 32 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01892488, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2020.