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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), Pakistan
ISRCTN ISRCTN95821329
DOI 10.1186/ISRCTN95821329
ClinicalTrials.gov identifier NCT00227331
EudraCT number
Public title 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), Pakistan
Scientific title
Acronym APPIS II
Serial number at source RPC116
Study hypothesis The proportion of children aged 3 to 59 months with World Health Organization (WHO) defined severe pneumonia who fail treatment in the oral amoxicillin group will not be greater than the proportion of those who fail in the parenteral ampicillin group.
Lay summary
Ethics approval Approval received from:
1. Local ethics board on the 2nd December 2004
2. WHO Ethics Research Committee (ERC) on the 23rd March 2005
Study design Randomised controlled trial
Countries of recruitment Pakistan
Disease/condition/study domain World Health Organization (WHO) defined severe pneumonia
Participants - 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
Participants - 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
Anticipated start date 24/02/2005
Anticipated end date 31/08/2008
Status of trial Completed
Patient information material
Target number of participants 2100
Interventions 1. Parenteral Ampicillin for 2 days then sent home on oral amoxicillin for 3 days
2. Oral Amoxicillin for 5 days
Primary outcome measure(s) 1. Clinical deterioration occurring any time after enrolment
2. Inability to take oral medication due to persisting vomiting as assessed by study physician
3. Change or addition of antibiotics
Secondary outcome measure(s) 1. Treatment failure between day 6 and 14
2. Clinical deterioration (development of danger signs) between day 6 and 14
3. Development of lower chest indrawing or fast breathing, which is non responsive to three trials of nebulisation with bronchodilator between day 6 and 14
Sources of funding 1. The Department of Child and Adolescent Health (CAH)/World Health Organization (WHO) (Switzerland)
2. US Agency for International Development (USAID) (USA)
Trial website
Publications Results in http://www.ncbi.nlm.nih.gov/pubmed/18177775
Contact name Dr  Shamim Ahmad  Qazi
  Address World Health Organization
20 Avenue Appia
  City/town Geneva-27
  Zip/Postcode CH 1211
  Country Switzerland
  Tel +41 (0)22 791 4853
  Email qazis@who.in
Sponsor The Department of Child and Adolescent Health (CAH)/World Health Organization (WHO) (Switzerland)
  Address 20 Avenue Appia
  City/town Geneva-27
  Zip/Postcode CH 1211
  Country Switzerland
  Tel +41 (0)22 791 4853
  Email qazis@who.int
  Sponsor website: http://www.who.int
Date applied 31/03/2006
Last edited 15/01/2008
Date ISRCTN assigned 31/03/2006
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