Please select the eligibility criteria that correspond to the clinical trial below.
Title: Prevention of Bacterial Infections in the Newborn by Pre-delivery Administration of Azithromycin (AZI): a Placebo-controlled Randomized Trial
Brief Summary: The last decade has witnessed an important reduction of the mortality in children under 5 years but such reduction has not impacted in neonates. Mortality in neonates contributes 40% of all deaths occurring in children below 5 years of age.

Severe bacterial disease is among the leading causes of neonatal deaths. Bacterial disease follows bacterial infection. Individuals can be infected without developing disease (carriage stage) but infection is needed to subsequently develop disease. In sub-Saharan Africa, bacterial carriage (i.e. in the birth canal and/or nasopharyngeal tract) is very common in all age groups, with the consequence that occurrence of bacterial disease is one of the highest in the world.

Newborns can be infected during labour - when passing through the birth canal - and during the first days/weeks of life, as a consequence of the close physical contact with the mother, if the latter carries bacteria in the nasopharyngeal tract.

If the mother is an important source of bacterial infection to the newborn, treating mothers with a powerful antibiotic during labour should decrease bacterial carriage and therefore diminish the risk of bacterial transmission to the newborn during the first days/weeks of life, which should in turn result in the lower occurrence of severe bacterial disease and hence lower mortality.

The purpose of this trial is to evaluate the impact of a single oral dose of azithromycin given to women in labour on bacterial carriage of the newborn as well as the women during the first month after delivery.

The investigators have selected an antibiotic (azithromycin) that in sub-Saharan Africa has already shown both a strong impact on bacterial nasopharyngeal carriage and on all-cause mortality when administered to everybody in a community (mass drug administration). This specific antibiotic has several advantages for being deployable as a simple intervention in rural Africa, i.e. it requires a single oral administration, it has no special storage requirements and it has the potential to eliminate many of the bacteria commonly causing severe disease in newborn.

This clinical trial will be conducted in a peri-urban health facility in Western Gambia. If an impact is shown, the next step would be to conduct a larger study aiming at establishing if the intervention, implemented at a lower level of care (most African women deliver at home assisted by traditional birth assistants), decreases the occurrence of neonatal bacterial disease


Options:
A: 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
B: 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
C: 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.
D: Inclusion Criteria:

* children with a diagnosis of chronic lung disease (CLD) secondary to bronchopulmonary dysplasia (BPD) as defined by ATS.
* children who receive primary care at High Risk Infant Clinic or High Risk Children's Clinic

Exclusion Criteria:

* Children with Cystic Fibrosis or bronchiectasis
* Children with cardiac arrhythmias
* Children with cyanotic heart disease
* Children with colitis
* Children with a known Macrolide allergy
* Children taking medications known to interact with macrolides
* Children with short bowel syndrome
* Children with kidney or liver failure

Answer: B