Please select the eligibility criteria that correspond to the clinical trial below.
Title: Clarithromycin as Immunomodulatory Therapy for the Management of Septic Syndrome by Ventilator-Associated Pneumonia
Brief Summary: The aim of this clinical trial is to clarify the clinical efficacy of clarithromycin as immunotherapy for the management of septic syndrome by ventilator-associated pneumonia.


Options:
A: Inclusion Criteria:

* Pregnant women (aged 18 to 45 years)
* in labour
* attending a health centre in western Gambia for delivery

Exclusion Criteria:

* Known HIV infection.
* Any chronic or acute conditions of the women that might interfere with the study as judged by the research clinician.
* Planned travelling out of the catchment area during the following 2 months (follow-up period)
* Planned caesarean section
* Known required referral
* Known multiple pregnancy
* Known severe congenital malformation
* Intrauterine death confirmed before randomization
* Known allergy to macrolides
* Consumption of antibiotic within the week before randomisation
B: Inclusion Criteria:

* Male or female, 6-18 years of age at enrollment
* Confirmed diagnosis of CF
* Written informed consent (and assent when applicable)
* Clinically stable at enrollment as assessed by the site investigator
* FEV1 % predicted \> 50%
* Ability to comply with medication use, study visits, and study procedures
* Ability to swallow a 250 mg tablet

Exclusion Criteria:

* Weight less than 18.0 kg
* Respiratory culture positive for P. aeruginosa, NTM, or B. cepacia complex within 1 year or at screening, or AFB positive at screening
* Allergy to macrolide antibiotics
* Use of macrolide antibiotics (e.g., azithromycin, clarithromycin) within 60 days of screening
* Use of systemic corticosteroids or intravenous or oral antibiotics within 14 days of screening
* Initiation of high dose ibuprofen, Pulmozyme®, hypertonic saline or aerosolized antibiotics within 30 days of screening
* Chronic therapy with drugs known to have rare but serious interactions with azithromycin: amiodarone, digoxin, disopyramide, lovastatin, pimozide, rifabutin, and nelfinavir
* Investigational drug use within 30 days of screening
* Laboratory abnormalities (creatinine, liver function or neutropenia) at screening and confirmed at follow-up testing prior to randomization
* History of biliary cirrhosis, portal hypertension, or splenomegaly, or splenomegaly on physical exam
* History of ventricular arrhythmia
* Other major organ dysfunction, excluding pancreatic dysfunction
* History of lung transplantation or currently on lung transplant list
* Relative decrease in FEV1 % predicted ≥ 20% between the screening and enrollment visit
* Positive serum pregnancy test at screening
* Pregnant, breastfeeding, or if post-menarche female, unwilling to practice birth control during participation in the study
* History of alcohol, illicit drug or medication abuse within 1 year of screening in the judgment of the site investigator
* Presence of a condition or abnormality that in the opinion of the site investigator would compromise the safety of the subject or the quality of the data
C: Inclusion Criteria:

* Adults, age ≥18 years, male or female.
* American Society of Anaesthesiology \[ASA\] status I, II or III.
* Non-starving patients presenting for surgery.
* Patients able to read and understand the information sheet and to sign the consent form.
* If the patient is female and of childbearing potential, she must have a negative pregnancy test

Exclusion Criteria:

* A history of allergy or hypersensitivity to erythromycin or other macrolides.
* Concomitant use of terfenadine, astemizole, cisapride, pimozid, cyclosporine, clarithromycine.
* Patient with acute intermittent porphyria.
* Acute or subacute necrosis of the liver, acute or subacute hepatitis, acute liver trauma
* Acute renal failure, acute glomerulonephritis, nephritic syndrome, chronic renal failure with electrolyte disorders, uremia
* Exacerbated asthma, exacerbated chronic obstructive lung disease, acute pulmonary infection
* Coronary heart disease (unstable angina, MI within the last 6 months), decompensated cardiac insufficiency, aortic aneurysm
* Polyneuropathy (for instance, due to diabetes mellitus)
* Patients with oesophageal and pharyngeal disease (i.e. oesophageal varices, oesophageal and pharyngeal cancer, Zenker's diverticulum).
* Status after gastric surgery, gastric bypass surgery, Nissen operation
* Patients with life threatening illness or injury needing immediate surgery
* Patients with moderate to severe head trauma (GCS on admission \<13)
* Psychological or psychiatric disorders.
* Dementia or inability to understand the study protocol.
* Women who are pregnant or are breast feeding.
* Patient scheduled for ileus surgery.
D: Inclusion Criteria:

1. written informed consent provided by first or second degree relatives;
2. intubation and mechanical ventilation at least 48 hours prior to enrolment; c) age of patients equal to or more than 18 years;

d) diagnosis of Ventilator Associated Pneumonia; and e) signs of sepsis

Exclusion Criteria:

1. neutropenia, defined as less than 500 neutrophils/mm3;
2. HIV infection;
3. oral intake of corticosteroids at a dose equal to or higher than 1mg/kg equivalent prednisone for a period greater than one month;
4. administration of drotrecogin alpha the last five days prior to enrolment; and e) atrioventricular block of second or third degree.

Answer: D