Please select the eligibility criteria that correspond to the clinical trial below.
Title: Cluster Randomized Trial of Community Case Management of the Severe Pneumonia With Oral Amoxicillin in Children 2-59 Months of Age in Hala and Matiari District, Pakistan
Brief Summary: Two-arm cluster randomized controlled trial located in Hala district, Pakistan to determine the impact of using Lady Health Workers (LHW) of National Program for Family Planning and Primary Health Care to diagnose and manage severe pneumonia with oral amoxicillin on treatment failure rates at day 6 among 2-59 month old children. LHWs in the control arm receive a refresher in standard pneumonia case management. LHWs in the intervention arm receive standard training that is enhanced to include training in the recognition of severe pneumonia and its home management with oral amoxicillin. Clusters are by Union Council (UC), administrator units consisting of 7 to 25 LHWs; each UC is randomized to either enhanced pneumonia case management with oral amoxicillin therapy (intervention) for severe pneumonia or standard case management and referral to the nearest health facility for treatment (control). Process indicators reflecting the LHW's ability to assess, classify and treat pneumonia in the intervention group and cost-effectiveness data is also being collected.

Primary Hypothesis:

Enhanced pneumonia case management and oral amoxicillin therapy for severe pneumonia delivered by LHWs in the community will result in a reduction in treatment failure among children 2 - 59 months of age with severe pneumonia who are treated by the LHW compared with those referred for care by the LHW.

Secondary Hypotheses:

1. The proportion of treatment failure, \[persistence of lower chest indrawing (LCI) or need for second line treatment between day 3 and day 14\], will be less in the intervention arm compared with the control arm.
2. LHWs can adequately assess, classify, and treat severe pneumonia in 2 - 59 month old children, and adequately recognize and refer children who present with danger signs during initial antimicrobial therapy.


Options:
A: Inclusion Criteria:

* children aged from 2 months to 5 years
* children diagnosed with severe community-acquired pneumonia, who require hospitalization.

Exclusion Criteria:

* chronical diseases
* severe comorbidities
* children admitted at PICU
B: Inclusion Criteria:

* Children aged 2-59 months with non-severe pneumonia based on WHO criteria of respiratory rate above the age specific cut-off with or without wheeze, accessible to follow up, whose guardians give written informed consent.

Exclusion Criteria:

* Children with severe disease, other infectious disease requiring antibiotic treatment, documented use of antibiotic for the last 48 hours, three or more episodes of wheezing in a year, diagnosed asthmatics, known immunodeficiency disease, acute or chronic organic disease, history of hospitalization within last 15 days, measles within last one month, drug allergy, refusal to give consent, prior enrollment in the study.
C: Inclusion Criteria:

* Signs and symptoms of pneumonia including at least 2 of the following: fever, cough, chest pain, shortness of breath, physical examination showing lung tissue has become airless and of solid consistency, white blood cell count \>15,000/uL or \<5000/uL (normal range is approximately from 3800/uL to 9800/uL)
* Chest x-ray showing evidence of lung infection
* Production of sputum (not an absolute requirement for enrollment
* however, all reasonable attempts to obtain a sputum specimen should be made
* Parental consent to participate in the study

Exclusion Criteria:

* Patients who have used antibiotics that affect the whole body for more than 24 hours immediately before the start of the study
* Requirement of antibiotic therapy that affects the whole body, other than study drug(s)
* Suspected infection with a bacteria known to be resistant to any of the study drugs
* Signs and symptoms of infection with a bacteria that affects the central nervous system
* History of a previous sensitivity or serious adverse reaction to any antibiotic similar to those used in this study
* History of cystic fibrosis
* Abnormal kidney function, as determined by blood test (serum creatinine)
* History or presence of joint disease or disease of the tissues surrounding joints, or any other signs or symptoms in muscles or bones that may make it difficult to evaluate any future complaints concernng muscles or bones
* Hospitalization or residence in a long-term care facility for 14 or more days before the beginning of pneumonia symptoms
* Infection acquired in a hospital
* Poorly controlled seizure disorder or at significant risk for seizures
* Unstable psychiatric disorder
* Known or highly suspected to be infected tuberculosis
* Known HIV (human immunodeficiency virus) infection requiring treatment to prevent PCP (pneumocystis carinii pneumonia
* a type of pneumonia that mainly affects those with compromised immune systems)
* Persistent use of corticosteroids
D: Inclusion Criteria:

* Age between 2 to 59 months who present to LHWs with severe pneumonia.
* Informed consent given by a legal guardian.

Exclusion Criteria:

* Very severe disease.
* Persistent vomiting.
* Parental or caretaker refusal to participate in the study.
* Children currently being treated for non-severe pneumonia who advance to severe pneumonia.
* Suspected or known kerosene oil ingestion.
* Prior enrollment in the study within 2 weeks of last follow up
* Children with severe malnutrition . Children with severe diarrhea with signs of dehydration

Answer: D