Please select the eligibility criteria that correspond to the clinical trial below.
Title: Belgian Trial With Azithromycin During Acute COPD Exacerbations
Brief Summary: This project (funded by the IWT-TBM program) will organize a randomized placebo-controlled multicenter intervention trial in 500 COPD patients to study the effectiveness and safety of azithromycin therapy in the acute setting of COPD exacerbations requiring hospital admission. Although long-term use of azithromycin is proven effective to prevent exacerbations, inherent risks outweigh the benefits. By reducing the dose and duration of the azithromycin treatment and by restricting the treatment to acute periods with highest risk for treatment failure, benefits may counterbalance potential side effects, which may result in a new treatment strategy for these acute events.

The present study is designed by the services of respiratory medicine of the Leuven and Ghent University hospitals but will run in total in 17 different large hospitals in Belgium, of which 12 are located in Flanders.


Options:
A: Inclusion Criteria:

* Established diagnosis of COPD by medical doctor (based on clinical history OR pulmonary function test)
* Smoking history of at least 10 pack-years (10 pack-years are defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years, etc.)
* Current hospitalization for potential infectious AECOPD treated with standard therapy
* History of at least one exacerbation during the last year (prior to the current hospital admission) for which systemic steroids and/or antibiotics were taken
* ECG at admission

Exclusion Criteria:

* Mechanical or non-invasive ventilation at moment of randomization (D1)
* Long QT interval on ECG (QTc \> 450msec for males or \> 470msec for females)
* History of life-threatening arrhythmias
* Myocardial infarction (NSTEMI or STEMI) less than 6 weeks before start of study drug
* Unstable angina pectoris or acute myocardial infarction (NSTEMI or STEMI) at admission
* Drugs with high risk for long QT interval and torsade de pointes (amiodarone, flecainide, procainamide, sotalol, droperidol, haldol, citalopram, other macrolides)
* Documented uncorrected severe hypokalemia (K+ \< 3.0 mmol/L) or hypomagnesemia (Mg2+ \< 0.5 mmol/L)
* Chronic systemic steroids (\> 4 mg methylprednisolone /day for ≥ 2 months)
* Actual use of macrolides for at least 2 weeks
* Allergy to macrolides
* Active cancer treatment
* Life expectancy \< 3 months
* Pregnant or breast-feeding subjects. Woman of childbearing potential must have a pregnancy test performed and a negative result must be documented before start of treatment
B: Inclusion Criteria:

* Male and non pregnant female aged 18 to 75 years
* Patients hospitalized in ICU, under mechanically assisted ventilation expected to be mandatory for 3 days or more
* Reasonable survival chance within next few days with an Apache score 10-25
* Tracheal aspirate found positive for P. aeruginosa
* The subject (or a close family member in case of incompetence) understands the procedure, agrees to participate, and is willing to give written informed consent
* Informed consent must be obtained for all subjects before enrollment in the study, by patient or by a close family member

Exclusion Criteria:

* Poor prognosis as judged by Apache score II score \>25
* Pregnant female
* Grossly under-or overweight (BMI\<18or \>29)
* Ongoing therapy with a macrolide
* Known allergy to any macrolide
* Proven P. aeruginosa pneumonia
* Ongoing anti-pseudomonal therapy with a proven susceptible colonizing strain
* Anticipated short duration of mechanical ventilation (\<3 days)
* Known drug interaction that could either decrease efficacy or raise safety concerns
* Severe hepatic failure (type C, score \>10 on Child Pugh scale)
* Sick sinus syndrome or long QT syndrome
* Recent donation of blood or participation in another clinical trial within 3 months
* Any situation exposing the patient to higher risk or possibly confounding results
C: Inclusion Criteria:

* Age 1-59 months,
* Plan to remain in study area greater than 6 months
* Discharged from hospital following non-trauma related admission

Exclusion Criteria:

* Contraindication to azithromycin use and other prophylactic antibiotic use
D: Inclusion Criteria:

* Patients with culture-positive stool sample with Campylobacter concisus
* Diarrheic patients ≥ 18 years
* symptoms of diarrhea defined as three or more watery stools per day or
* two watery stools per day + at least one of the following symptoms: abdominal pain, nausea, vomiting or fever.
* Diarrheic symptoms for a minimum of 24 hours before enrollment.
* Diarrheic symptoms for a maximum of 21 days before enrollment.
* Informed oral and signed written consent, with documentation that all relevant information about the study is given to the patient.
* The patient must be willing and able to participate in the trial.

Exclusion Criteria:

* Hypersensitivity to azithromycin, erythromycin, macrolide or other ketolide-antibiotics
* Pregnancy or breastfeeding (if relevant).
* Culture positive stool sample with a Co-pathogen.
* Treatment with other antibiotics (in any stage 21 days before the first stool sample).
* Patients with severe liver disease.
* Patients with severe renal impairment (GFR \<10 ml / min).
* Patients with congenital or documented acquired QT prolongation.
* Patients treated with other active drugs that prolong the QT interval such as: antiarrhythmics of classes IA and III, cisapride and terfenadine.
* Patients with electrolyte disorders, particularly hypokalemia and hypomagnesemia.
* Patients with clinically relevant bradycardia, arrhythmia or severe heart failure.
* Inflammatory bowel diseases
* Chronic diarrhea of known cause.
* Dementia.
* Serious illness less than 21 days from the planned entry into the study.
* Patients treated with medications that have interactions with azithromycin e.g. alkaloids, ciclosporin or amiodarone.
* Patients involved in the planning or execution of the study.

Answer: A