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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
by International Vaccine Access Center on 16 October 2012

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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
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