Contact information
Type
Scientific
Primary contact
Dr Shamim Ahmad Qazi
ORCID ID
Contact details
World Health Organization
20 Avenue Appia
Geneva-27
CH 1211
Switzerland
+41 (0)22 791 4853
qazis@who.in
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00227331
Protocol/serial number
RPC116
Study information
Scientific title
Acronym
APPIS II
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.
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
World Health Organization (WHO) defined severe pneumonia
Intervention
1. Parenteral Ampicillin for 2 days then sent home on oral amoxicillin for 3 days
2. Oral Amoxicillin for 5 days
Intervention type
Drug
Phase
Not Specified
Drug names
Amoxicillin, ampicillin
Primary outcome measures
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 measures
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
Overall trial start date
24/02/2005
Overall trial end date
31/08/2008
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
2100
Participant 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
Recruitment start date
24/02/2005
Recruitment end date
31/08/2008
Locations
Countries of recruitment
Pakistan
Trial participating centre
World Health Organization
Geneva-27
CH 1211
Switzerland
Sponsor information
Organisation
The Department of Child and Adolescent Health (CAH)/World Health Organization (WHO) (Switzerland)
Sponsor details
20 Avenue Appia
Geneva-27
CH 1211
Switzerland
+41 (0)22 791 4853
qazis@who.int
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
The Department of Child and Adolescent Health (CAH)/World Health Organization (WHO) (Switzerland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
US Agency for International Development (USAID) (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
Results in http://www.ncbi.nlm.nih.gov/pubmed/18177775
Publication citations
-
Results
Hazir T, Fox LM, Nisar YB, Fox MP, Ashraf YP, MacLeod WB, Ramzan A, Maqbool S, Masood T, Hussain W, Murtaza A, Khawar N, Tariq P, Asghar R, Simon JL, Thea DM, Qazi SA, , Ambulatory short-course high-dose oral amoxicillin for treatment of severe pneumonia in children: a randomised equivalency trial., Lancet, 2008, 371, 9606, 49-56, doi: 10.1016/S0140-6736(08)60071-9.