Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hannover Medical School
With
Capnetz Stiftung
Age
40–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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.
Patients must sign and date an informed consent prior to any study procedures.
You may not be 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
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.
Clareo Health | Study to Demonstrate That Antibiotics Are Not Needed in Moderate Acute Exacerbations of COPD
