Condition category
Respiratory
Date applied
31/03/2006
Date assigned
31/03/2006
Last edited
15/01/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.who.int

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

  1. 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.

Additional files

Editorial Notes