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

Completed

• Conditions: World Health Organization (WHO) defined severe pneumonia; Respiratory; Pneumonia

• Registration Number: ISRCTN95821329
• Lead Sponsor: The Department of Child and Adolescent Health (CAH)/World Health Organization (WHO) (Switzerland)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03-31
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 2100

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
10. Living outside a pre-defined area
11. Parental or caretaker refusal to participate in the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified