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PERCH (Pneumonia Etiology Research for Child Health) - Program Overview

The PERCH project is a rigorous multi-country, case-control study of hospitalized pediatric patients with severe lower respiratory tract illnesses to determine the etiology and risk factors associated with the syndrome. By Dr. Orin Levine at ISPPD8

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Transcript of PERCH (Pneumonia Etiology Research for Child Health) - Program Overview

Why do we need PERCH?
Progress
Research
PERCH
Study Design
What's changing?
(cc) photo by Metro Centric on Flickr
Pneumonia Etiology Research for Child Health
By 2015 and beyond, the current evidence base for vaccine development and treatment won't represent pneumonia etiology distributions.
Interventions, people, environments & measurements
Hib and PCV in developing world
Malaria prevention efforts
HIV prevalence
Urbanization
Economic Growth
New diagnostics to detect respiratory pathogens
2000
2015
Assumes ~90% reduction in Hib/pnc deaths,
and 44% reduction in other and unknown deaths
Causes of Pneumonia Deaths
The Changing Pneumonia 'Pie'
5 year project
Planning, site selection, methods and standardization
Case-control study (2 years enrollment)
Lab work
Analysis
Select high quality, representative sites.
Develop methods for analyzing & interpreting etiology data.
Assess novel diagnostic assays.
Establish standard clinical, lab and data management definitions & methods.
Determine the association between pneumonia and infection.
Estimate the fraction of pneumonia attributable to different pathogens.
Assess putative risk factors for different pathogens.
All analyses to include both bacterial and viral pathogens, both well-characterized and novel.
Determine the association between disease severity and etiology.
Develop a set of specimens for novel pathogen discovery among episodes with no known etiology.
Determine patterns of microbial resistance.
Develop a set of isolates of key pathogens.
Develop a robust clinical severity index.
Provide a robust platform for ancillary studies of pneumonia epidemiology.
(cc) photo by Metro Centric on Flickr
(cc) photo by Metro Centric on Flickr
(cc) photo by Metro Centric on Flickr
(cc) photo by Metro Centric on Flickr
(cc) photo by Metro Centric on Flickr
Cases:
hospitalized
severe OR very severe pneumonia,
ages 1-59 months
New Zealand
Seattle
Atlanta
Boston
Blood
NP & OP swabs
Urine
Demographic, clinical history & risk factor assessment
Limited clinical assessment (respiratory & neurological signs, etc.)
Analysis using Bayesian hierarchical modeling
Pathogen discovery?
New biomarkers?
New diagnostics?
Stronger institutions
Knowledge & biorepository
Standardized methods
Your Ideas?
2009
2013
2011
PERCH
Innovations?
What can we get out of PERCH?
5 years from now...
Stage 1 (18 months)
2010
2012
2014
Stage 2 (42 months)
Project Timeline
Planning
Site selection
Method
development
Enrollment in case-control study & lab work
Analysis
Capturing study data on forms like this
On computers
and the internet
Clinical Standardization
In places like this
Lectures by Dr. Jane Crawley

Q & A & Interactive sessions

Case scenarios & Practical sessions

Assessment & feedback

Certificates, accreditation number

Identification of on-site PERCH clinical trainer
Training: before & after enrollment
What is standardized?
Recognition & assessment of the critically ill child

WHO criteria for severe & very severe pneumonia

Other key respiratory and non-respiratory signs

Clinical measurements

Weight, height / length, MUAC

Temperature

Pulse oximetry

Use of digital stethoscope
Bronchodilator challenge

Naso- & oro-pharyngeal swabs

Induced sputum collection

Blood culture collection
Digital auscultation
Electronic Data Capture
Thanks
Stage 1 Objectives
PERCH Primary Objectives
PERCH Secondary Objectives
Stage 1
Stage 2
Thank you to the PERCH team at IVAC and the global team of PERCH investigators, collaborators and staff who make the project work everyday, around the world.

This project is made possible by a grant from the Bill & Melinda Gates Foundation.

PERCH protocol, CRFs, & SOPs are available at www.jhsph.edu/ivac/perch.html

PERCH Supplement - Open Access on Clinical Infectious Diseases website http://cid.oxfordjournals.org/content/54/suppl_2
Enrollment to date
Controls:
frequency matched on age
from catchment area
without severe or very severe pneumonia
Cases & Controls
Control Specimen
Collection & Evaluations
Standardization is key
BOSTID study
10 countries, 1 case definition at beginnning
BUT...
3 countries modified RR cut-offs,
3 added "clinical pneumonia",
1 dropped stridor & wheeze
Laboratory evaluations
Specimen collection & transport

Standard equipment and reagents
Nucleic acid extraction
PCR machines

Bacteriology and quantification
PCR's Evolution
Standardization in PERCH
Clinical
Data management
Laboratory
Illustrative etiology before Hib & PCV use
The Changing Pneumonia 'Pie'
Future
Source: Scott JAG J Clin Invest 2008
0
48h
Clinical
24h
Discharge
30d
Follow-up
Case Enrollment and Follow-up
Demographic info
Clinical assessment
X-rays & digital auscultation*
Specimen
NP/OP
Induced sputum
Blood
Urine
*
[Gastric aspirate, pleural fluid, lung aspirate]
O2 sat, RR, wheeze, chest indrawing
O2 sat, RR, wheeze, chest indrawing
O2 sat, RR, wheeze
Vital status, convalescent serum
Measurements include
PCR positive vs. negative
qPCR
Semi-quantitative culture results
CRP
Future biomarkers?
Clinical symptoms & signs
Diagnostic procedures
Full transcript