Pneumoniae Epidemiology Study in China

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00471770
First received: May 8, 2007
Last updated: March 12, 2008
Last verified: March 2008
  Purpose

To determine the proportion of hospitalized pneumonia cases in children aged 60 months or less associated with vaccine-preventable Streptococcus pneumoniae serotypes (4, 6B, 9V, 14, 18C, 19F, 23F).


Condition
Pneumococcal Disease

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Epidemiological Study of Hospitalized Pediatric Pneumonia in China

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • The proportion of hospitalized pneumonia cases associated with vaccine-preventable S. Pneumoniae serotypes (4, 6B, 9V, 14, 18C, 19F, 23F). [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

deep respiratory aspirate,pleural fluid,cerebrospinal fluid,serum


Estimated Enrollment: 1000
Study Start Date: February 2007
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
1.Core group: enrolled subjects who have isolated pneumococcal
2
2.SPN group:enrolled subjects who have no isolated pneumococcal
3
3.DCF group: Subjects screened but not enrolled

Detailed Description:

Subjects meeting the eligibility criteria, including parental informed consent to collect clinical-epidemiological information, will have a deep respiratory aspirate specimen to determine the etiology of the lower respiratory tract infection. Clinicians may obtain other diagnostic specimens, such as pleural fluid, lung tap, cerebrospinal fluid, nasopharyngeal culture, or serum for serological assays, as indicated clinically. The chest radiograph will be taken and read locally according to predetermined criteria and by staff radiologists trained in radiographic criteria for pneumonia. Bacterial isolates other than Streptococcus pneumoniae will be identified according to standardized procedures. S. pneumoniae isolates will be transported to central laboratories for confirmation of identity, serotyping and antibiotic resistance testing, using standard techniques. Serotype will be determined using type-specific sera (Quellung reaction). Antibiotic susceptibility to penicillin, cefuroxime, ceftriaxone, erythromycin, Amoxycillin, Ofloxacin, Vancomycin, and imipenem be conducted using E-test according to standardized procedures at the central facilities.

  Eligibility

Ages Eligible for Study:   up to 60 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Hospitalized children with pneumoniae less than 5 years,located in Tianjin Children's Hospital

Criteria

Inclusion Criteria:

  • Age, 60 months or less
  • Meets study criteria for clinical pneumonia
  • All the examination are/can be done within (before or after) 72 hours to enrollment time
  • Informed consent obtained from parent or guardian

Exclusion Criteria:

  • Received any pneumococcal vaccine in the past
  • Current or underlying conditions that would pose a hazard in obtaining the deep respiratory aspirate (e.g., bleeding diathesis, severe respiratory compromise and others as determined by clinician) Aspirates may be obtained from patients who are intubated
  • Any other medical condition that in the opinion of the clinician/investigator would pose a hazard to the child by participating in the study
  • Children with recurrent pneumonia will enter into the study on only one occasion
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00471770

Locations
China
Tianjin, China, 300074
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00471770     History of Changes
Other Study ID Numbers: 0887X-101894
Study First Received: May 8, 2007
Last Updated: March 12, 2008
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on July 23, 2014