Please select the eligibility criteria that correspond to the clinical trial below.
Title: IndiaCLEN Multicentric Trial of Home Versus Hospital Oral Amoxicillin for Management of Severe Pneumonia in Children
Brief Summary: The purpose of this study is to determine the safety and efficacy of oral amoxicillin in treating WHO defined severe pneumonia(cough and fast breathing with lower chest indrawing) at home and at hospital using an open labelled multicentric prospective two-arm randomized clinical trial to determine the differences in failure of treatment with a 7 day course of oral amoxicillin administered for first 48 hours in the hospital in comparison to being sent home after enrolment, in children 3 to 59 months old who have severe pneumonia. The investigators developmental hypothesis were to test whether the community/home based oral amoxicillin is efficacious for treating severe pneumonia.


Options:
A: Inclusion Criteria:

* Clinical signs of WHO-defined severe pneumonia
* Age 2 months to 59 months

Exclusion Criteria:

* Clinical signs of WHO-defined very severe pneumonia
* Clinical or laboratory diagnosis of meningitis
* Clinical diagnosis of severe malnutrition (marasmus/kwashiorkor)
* Clinical or laboratory diagnosis of severe anaemia requiring transfusion
* HIV-exposure on rapid HIV antibody test (only observational data will be collected from these patients)
* Elimination of signs of severe pneumonia in a child with wheeze after outpatient bronchodilator therapy
* Chronic condition that may underlie or contribute to a presentation with respiratory distress such as: known chronic renal or cardiac disease, presence of cerebral palsy predisposing child to aspiration/hypostatic pneumonia
* Established bronchiectasis or congenital abnormality of the lower respiratory tract
* Upper airway obstruction producing stridor
* Admission from outpatient clinic specifically for treatment of TB
* Referral from another inpatient facility following treatment with injectable antibiotics for more than 24 hours or because the initial regimen is considered to have failed
* Documented history of \>48hours treatment with oral amoxicillin
* Failure to obtain informed consent
* Penicillin allergy
B: Inclusion Criteria:

* Children aged 3 to 59 months with pneumonia and lower chest wall indrawing
* Ability to take orally
* Absence of radiological consolidation or effusion
* Informed consent by a legal guardian

Exclusion Criteria:

Children with any of the following conditions:

* Very severe pneumonia/disease
* Respiratory rate \> 70/min
* Persistent vomiting
* Known prior episodes of asthma, or, three or more prior episodes of wheezing
* LCI that resolves after three doses of bronchodilator therapy1
* Documented use of prior oral antibiotics for 48 hours
* Severe malnutrition (weight for height \< 3SD or kwashiorkor)
* Known penicillin or amoxicillin allergy
* Hospitalization in the last two weeks
* Known or clinically recognizable HIV, congenital cardiac or respiratory anomalies, chronic lung disease including bronchopulmonary dysplasia, neurological impairment that affects respiratory function, renal diseases, malignant or haematological diseases.
* Other diseases requiring antibiotic therapy at presentation, such as meningitis,dysentery, osteomyelitis, septic arthritis, evident tuberculosis, etc.
* Anaemia requiring blood transfusion
* Kerosene poisoning
* Measles in the last 15 days
* Previous inclusion in the study or already included in another study
* Living outside a pre-defined area
* Parental or caretaker refusal to participate in the study
C: Inclusion Criteria:

* Patients suffering from nosocomial pneumonia or ventilator-associated pneumonia
* Female patients must be postmenopausal for at least 1 year, surgically sterile, or practicing an effective method of birth control, before entry and throughout the study, and have a negative serum or urine pregnancy test at the screening

Exclusion Criteria:

* Known or suspected hypersensitivity to any related antibiotic medications
* Any known or suspected condition or concurrent treatment that would be contraindicated by the prescribing information
* Treatment with any investigational drug within 30 days before enrollment
* Prior enrollment to this study
D: Inclusion Criteria:

* Adult inpatients
* Clinically significant, microbiological-documented infection caused by carbapenem-resistant and colistin-susceptible Gram-negative bacteria and identified according to CDC criteria- blood stream infections, hospital acquired pneumonia, ventilator associated pneumonia, and urinary tract infections
* Patient recruitment will occur only after microbiological documentation and susceptibility testing. Patients will be included within 96 hours of the time the index culture was taken (typically within 48 hours of isolate identification), regardless of the antibiotic treatment administered during this time period.

Exclusion Criteria:

* Previous inclusion in the trial. Patients will be included in the RCT only once for the first identified episode of infection
* Pregnant women
* Epilepsy or prior seizures
* Known allergy to colistin or a carbapenem

Answer: B