Child Pneumococcal Serotype Epidemiology In Greece

NCT01111214 | Completed

• 2 other identifiers: 0887X1-4434B1841010
• Study Type: observational
• Target: 457
• Locations: 1 country
• Sites: 9

Brief Summary

Streptococcus pneumoniae is a major cause of pneumonia, sepsis, bacteremia, and pneumococcal meningitis among infants and children worldwide. The 7-valent conjugate pneumococcal vaccine (Prevenar) has been introduced in the Greek Market in 2004. Additionally, as of 2006 Prevenar has been included in the Greek National Immunization Program. The effect of the mass vaccination on the incidence of pneumococcal serotypes involved in the occurring invasive pneumococcal disease, is an important factor to consider for the introduction of the 13-valent pneumococcal conjugate vaccine.

Conditions

Pneumococcal Disease

Keywords

Invasive Pneumococcal Disease (IPD); pneumococcal serotypes

Outcome Measures

Primary Outcomes (1)

• The serotype distribution of invasive S. pneumoniae isolates of hospitalized children up to 14 years of age after the introduction of the 7-valent conjugate pneumococcal vaccine

  yearly

Secondary Outcomes (3)

• Serotype distribution of resistant S. pneumoniae isolates

  yearly

• Serotype distribution of IPD between immunized and non immunized children ≤14 years of age

  yearly

• Antimicrobial susceptibilities of IPD isolates and rates of resistance to penicillin

  yearly

Study Arms (1)

group 1

Hospitalized children ≤14 years of age with invasive pneumococcal disease

Other: no intervention

Interventions

no intervention OTHER

There is no intervention. This is a non interventional study.

group 1

Eligibility Criteria

• Age: Up to 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Hospitalized children in participating centers

You may qualify if:

• Children aged 14 years old or less.
• Hospitalized in a participating healthcare facility with an IPD.
• IPD will be confirmed by isolation of S. pneumoniae from a sterile body site.

You may not qualify if:

• Children \> 14 years of age
• Unconfirmed IPD

Sponsors & Collaborators

• Pfizer: lead

Study Sites (9)

Agia Sophia Children's Hospital

Athens, Attica, 115 27, Greece

Location

University Hospital of Herakleion

Heraklion, Herakleion, 70013, Greece

Location

Venizeleion General Hospital of Herakleion

Heraklion, Herakleion, 71409, Greece

Location

University Hospital of Ioannina

Ioannina, Ioannina, 45332, Greece

Location

Ahepa Hospital Paediatric Outpatient Special Clinic 1st Kyri

Thessaloniki, Thessaloniki, 54636, Greece

Location

Ippokrateion Peripheral Hospital of Thessaloniki

Thessaloniki, Thessaloniki, 54642, Greece

Location

Peripheral Hospital of Trikala

Trikala, Trikala, 42100, Greece

Location

University Hospital of Alexandroupolis

Alexandroupoli, 68100, Greece

Location

University of Thessaly School of Medicine

Larissa, 415 00, Greece

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Pneumococcal Infections

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2010
• First Posted: April 27, 2010
• Study Start: November 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: January 10, 2013

Record last verified: 2013-01

Locations

GR (9)