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Pneumoniae Epidemiology Study in China

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00471770
First Posted: May 10, 2007
Last Update Posted: March 13, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
May 8, 2007
May 10, 2007
March 13, 2008
February 2007
February 2008   (Final data collection date for primary outcome measure)
The proportion of hospitalized pneumonia cases associated with vaccine-preventable S. Pneumoniae serotypes (4, 6B, 9V, 14, 18C, 19F, 23F). [ Time Frame: 1 year ]
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Complete list of historical versions of study NCT00471770 on ClinicalTrials.gov Archive Site
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Pneumoniae Epidemiology Study in China
Epidemiological Study of Hospitalized Pediatric Pneumonia in China
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).
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.
Observational
Time Perspective: Prospective
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Retention:   Samples Without DNA
Description:
deep respiratory aspirate,pleural fluid,cerebrospinal fluid,serum
Non-Probability Sample
Hospitalized children with pneumoniae less than 5 years,located in Tianjin Children's Hospital
Pneumococcal Disease
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  • 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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1000
February 2008
February 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
up to 60 Months   (Child)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT00471770
0887X-101894
Yes
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Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
March 2008