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Projects

PERCH Study Details

About PERCH: Pneumonia Etiology Research for Child Health

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.

Program Overview

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Objectives

Primary Objectives

  • Determine the association between pneumonia and infection with known and putative viral, bacterial, mycobacterial, and fungal pathogens.
  • Estimate the fraction of pneumonia attributable to pathogens for which vaccines are currently under development (including S. pneumoniae common protein vaccines, respiratory syncytial virus (RSV), parainfluenza virus (PIV), influenza and Staphylococcus aureus) as well as other known, but poorly quantified causes of pneumonia in children including, but not limited to, non-typeable H. influenzae, non-typhoidal Salmonellae, human metapneumovirus, M. tuberculosis, Pneumocystis jiroveci, and potentially fastidious bacteria.
  • Assess putative factors for infection and/or disease due to novel or under-recognized pneumonia pathogens.

Secondary Objectives

  • Determine the association between disease severity and etiology.
  • Develop a set of specimens for novel pathogen discovery among episodes with no known etiology (completely negative with comprehensive testing).
  • Determine patterns of antimicrobial resistance among invasive isolates including, but not limited to, M. tuberculosis, S. aureus, and S. pneumoniae.
  • Develop a set of isolates of key pathoegens associated with pneumonia including, but not limited to, influenza, S. pneumonia, non-typhoidal Salmonellae, and S. aureus for molecular epidemiologic analyses.
  • Develop a robust clinical severity index based on analyses of PERCH putative criteria and outcomes.
  • Provide a robust platform for ancillary studies of pneumonia epidemiology including, but not limited to, the utility of digital auscultation, chest radiograph, and viral quantification.

Sites

Seven PERCH sites have been selected:
  • Johannesburg, South Africa
  • Lusaka, Zambia
  • Kilifi, Kenya
  • Basse, the Gambia
  • Bamako, Mali
  • Sa Kaeo and Nakhon Phanom, Thailand
  • Dhaka, Bangladesh

PERCH Study Sites

Site

Country

PI Name

Institution

HIV

Urban/Rural

<5 Mortality Rate

Kilifi

Kenya

Anthony Scott

Kilifi-KEMRI Wellcome Trust

Medium

Rural

60

Dhaka

Bangladesh

Abdullah Brooks

ICDDR,B

Low

Mixed

88

Basse

Gambia

Stephen Howie

MRC

Low

Rural

109

Johannesburg

South Africa

Shabir Madhi

University of Witswatersrand;
RMPRU

Very High

Urban

63

Bamako

Mali

Karen Kotloff

University of Maryland

Low

Urban

196

Sa Kaeo,
Nakhon Phanom

Thailand

Susan Maloney

CDC - Thailand

Low

Mixed

18

Lusaka

Zambia

Donald Thea

Boston University

High

Urban

135


Partners

Collaborating institutions include the University of Witswatersrand in Johannesburg, South Africa, KEMRI Wellcome Trust Research Programme in Kilifi, Kenya, the University of Maryland’s Center for Vaccine Development in Bamako, Mali, the Thailand Ministry of Public Health – United States Centers for Disease Control and Prevention Collaboration’s at two sites in rural Thailand, Boston University at the University Teaching Hospital of Lusaka, Zambia, the Medical Research Council Unit in Basse, The Gambia and theInternational Centre for Diarrhoeal Disease Research, Bangladesh (ICDDR, B) in Dhaka with laboratory testing led by theUniversity of Otago and Canterbury Health Laboratories in Christchurch, New Zealand.

Organogram

PERCH Organogram

Core Team

The PERCH Core Team is led by Dr. Orin Levine, the overall Principal Investigator. His roles include oversight of the entire project, providing strategic direction, management of personnel and budgets and assuring scientific conduct of high quality and integrity. H is supported in this leadership role by co-PIs (Drs. Kate O'Brien, Anthony Scott and Maria Knoll). From a management perspective and study conduct perspective, the PERCH Core Team has a Secretariat consisting of Dr. Orin Levine, Dr. Kate O'Brien and Dr. David Murdoch, who, along with the site PIs form the PERCH Executive Committee. Other PERCH core team members include pediatricians, epidemiologists, laboratory scientists, and statisticians based at JHSPH.

Each Working Group has a Team Leader from the PERCH Core Team whose responsibility is to direct that section of the project in keeping with the scientific objectives, in a consistent manner across Working Groups, whilst accounting for inherent variations in site capacity and practical setting. It is the responsibility for the Team Leader and the PERCH coordinators assigned to that Working Group to convene regular communication, and identify and propose approaches to the study design, conduct and monitoring. The Team Leaders report to the PERCH PI and co-PIs.

Core Team members participate in Working Groups according to their experience and knowledge. Dr. O'Brien participates in all Working Groups, assuring there is cross working group cohesion and integration. The Team Leaders report to the PERCH Core Team on a weekly basis thereby assuring that Working Group decisions, needs and approaches are kept on track from a strategic, budget and scientific perspective. The Core Team participation in the Working Groups is as follows but other Core Team Members will participate in an ad hoc fashion according to the needs of the Working Group.

Study Design

Specimens

Multiple specimens will be obtained from each case and control:

  • Acute blood
  • Convalescent blood (cases only)
  • Nasopharyngeal and oropharyngeal swabs
  • Induced sputum or gastric aspirate if sputum is not obtained (cases only)
  • Pleural fluid (cases only, when clinically indicated)
  • Lung aspirates (cases only, in select sites)
  • Urine
  • Post mortem lung needle biopsy (fatal cases only, in select sites)

Sample size

Over two years, the PERCH study aims to enroll between 5000-7000 patients with severe or very severe pneumonia and an approximately equal number of controls using a standardized methodology that will facilitate pooled analysis. As such, the study is expected to provide substantial power to detect new etiologies of pneumonia, to offer improved precision on existing estimates, and in case-control analyses, to determine associations with risk factors that may not have been possible previously.