Please select the eligibility criteria that correspond to the clinical trial below.
Title: Azithromycin to Prevent Post-discharge Morbidity and Mortality in Kenyan Children
Brief Summary: Children hospitalized with severe illness in sub-Saharan Africa are at high risk of morbidity and mortality following discharge from hospital. These children represent an accessible high-risk population in which targeted interventions to prevent morbidity and mortality could have dramatic impact. A large cluster randomized trial of azithromycin delivered in a mass drug administration program within trachoma endemic areas in sub-Saharan Africa demonstrated an almost 50% mortality benefit in children 1-9 years of age in treated communities. However, mass drug administration of azithromycin leads to the rapid emergence of macrolide resistance within treated communities and is expensive. The targeted delivery of azithromycin to children at hospital discharge may be a novel and practical intervention to maximize benefit while minimizing risk of antibiotic resistance. This is a randomized, double-blind, placebo-controlled trial to determine the efficacy of azithromycin provided at discharge, compared to placebo, in reducing mortality and re-hospitalization rates in children age 1-59 months in Kenya. The study will also investigate potential mechanisms by which azithromycin may reduce morbidity and mortality in this population and will assess the emergence of antibiotic resistance among treated individuals and their primary caregivers. A cost-effectiveness analysis of the intervention will also be conducted.


Options:
A: Inclusion Criteria:

* Clinical Diagnosis of COPD
* Clinically stable for 6 weeks
* Able to Swallow Tablets

Exclusion Criteria:

* Clinically significant respiratory disease other than COPD
* Women of child bearing age
* Patients receiving existing Medication which may interact adversely with trial drug
* History of clinically significant liver disease
B: 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.
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 meeting all of the following criteria will be considered for admission to the study:

* Adults, either sex, ages 18-55 years or age 56 to 65 with \< 20 pack year smoking history or \>65 with \<5 pack year smoking history
* Patients with a documented history of asthma for \>6 consecutive months, and
* Patients presenting within 48 hours (of initial presentation to medical care) with an acute deterioration in asthma control (increased wheeze, dyspnea and/or cough and/or reduced PEF) and requiring a course of oral steroids
* Patients with a PEF or FEV1 less than 80% of predicted normal or patient's best at presentation, at recruitment or in the time elapsed between presentation and recruitment
* 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

Patients presenting with any of the following will not be included in the study:

* Patients with known prolongation of the QT interval, a history of torsades de pointes, congenital long QT syndrome, bradyarrhythmias or uncompensated heart failure, patients on drugs known to prolong the QT interval and patients with ongoing proarrhythmic conditions such as uncorrected hypokalemia or hypomagnesemia, clinically significant bradycardia, and patients receiving Class IA (quinidine, procainamide) or Class III (dofetilide, aminodarone, sotalol) antiarrhythmic agents.
* Smokers aged 56-65 with a \>20 pack year history, or aged \>65 with \>5 pack year history
* Patients requiring immediate placement in ICU
* Patients who used oral or systemic antibiotics within 28 days prior to enrolment
* Patients with known impaired hepatic function (ALT/AST \> 2 ULN)
* Patients with significant lung disease (including COPD) other than asthma
* Patients with \> 20mg oral corticosteroid maintenance therapy
* Patients requiring other antibiotic therapy
* Patients who are receiving other medications or who have other disease conditions or infections that could interfere with the evaluation of drug efficacy or safety
* Women who are breast-feeding or are pregnant, as demonstrated by a urine pregnancy test carried out before exposure to study medication or the start of any study procedure that could pose a risk to the foetus
* Patients with suspected or known hypersensitivity to, or suspected serious adverse reaction to Azithromycin or any of the macrolide or ketolide class of antibiotics, erythromycin or to any excipients thereof
* 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 a concomitant condition (including clinically relevant cardiovascular, hepatic, neurologic, endocrine, or other major systemic disease) making implementation of the protocol or interpretation of the study results difficult
* 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.
* No subject will be allowed to enrol in this study more than once.

Answer: C