Please select the eligibility criteria that correspond to the clinical trial below.
Title: Effectiveness of 3 Day Amoxycillin Versus 5 Day co-Trimoxazole in the Treatment of Non-Severe Pneumonia in Children Aged 2- 59 Months of Age: - A Multi-Centric Open Labeled Trial
Brief Summary: Background: With documented rise in bacterial resistance in vitro to co-trimoxazole, there is a need to document in vivo effectiveness of the drug in treatment of non-severe pneumonia in the community setting.

Setting: The study will be conducted in 18 rural primary health center (PHC) in 9 districts in India near Lucknow, Nagpur, New Delhi, Mumbai, Chennai, Trivandrum, Vellore, Chandigarh and Bhopal.

Design: The unit of randomization will be the PHC. The recruited children will be followed up on days 4, 6 and 13-15 to assess primary and secondary outcome measures.

Hypothesis: The primary hypothesis is that the clinical failure rate with use of either oral amoxycillin for three days or five days co-trimoxazole is similar.

Intervention: Oral Co-trimoxazole (8mg/kg/day trimithoprim) twice a day for five days vs. oral amoxycillin (20 mg/kg/day) thrice a day for three days.

Main objective: To compare the proportion of children aged 2 to 59 months presenting with non-severe pneumonia with or without wheeze, who do achieve clinical cure on day 6 on treatment with 5 days oral co-trimoxazole and 3 day oral amoxycillin, respectively.

Main outcomes measures: Clinical cure on day 6; clinical failure between day 1-6; clinical relapse between day 7-15.

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.

Sample size: Has been calculated to test the null hypothesis. There will be 1100 children in each arm. Thus each PHC is required to recruit a minimum of 122 cases within one year.

Policy relevance: The findings of the study can effect the ARI management policy. If the current study proves that three day amoxycillin is clinically as effective as five day co-trimoxazole and with the well documented evidence of rising resistance to co-trimoxazole, short course amoxycillin may become the first line treatment for non-severe pneumonia Time line: 18 months. Pilot in March 2003, enrollments from April 2003, Interim analysis Nov. 2003, DMC meet Dec. 2003, Data cleaning June 2004, DMC meet July 2004, Manuscript writing Aug.2004.


Options:
A: 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
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:

* 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
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: B