ISRCTN95821329
Completed
Not Applicable
Multicentre prospective randomised clinical trial to compare the safety and efficacy of outpatient treatment with oral amoxicillin with that of injectable ampicillin in children aged 3 to 59 months: APPIS II Randomised Controlled Trial (RCT), Pakista
The Department of Child and Adolescent Health (CAH)/World Health Organization (WHO) (Switzerland)0 sites2,100 target enrollmentMarch 31, 2006
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- The Department of Child and Adolescent Health (CAH)/World Health Organization (WHO) (Switzerland)
- Enrollment
- 2100
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Children aged 3 to 59 months with severe pneumonia. Severe pneumonia is defined as Lower Chest Indrawing (LCI) in children with cough and/or difficult breathing, who are able to drink and do not have central cyanosis, regardless of the respiratory rate
- •2\. Known Human Immunodeficiency Virus (HIV) infected patients in clinical category N or A (Centers for Disease Control \[CDC]) will be included
- •3\. Informed consent by a legal guardian
Exclusion Criteria
- •Children with any of the following conditions will be excluded:
- •1\. Very severe pneumonia/disease
- •2\. Known prior episodes of asthma or three or more prior episodes of wheezing
- •3\. LCI that resolves after three doses of bronchodilator therapy
- •4\. Severe malnutrition (visible severe wasting or oedema)
- •5\. Known anaphylactic reaction to penicillin or amoxicillin
- •6\. Hospitalisation in the last two weeks
- •7\. Other diseases requiring antibiotic therapy at presentation, such as meningitis, dysentery, osteomyelitis, septic arthritis, evident tuberculosis etc.
- •8\. Persistent vomiting
- •9\. Previous inclusion in the study
Outcomes
Primary Outcomes
Not specified
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