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Pneumoniae Epidemiology Study in China

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NCT00471770

Last updated on April 10, 2018
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FOR MORE INFORMATION
Study Location
Tianjin, , 300074 China
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pneumococcal Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0-60
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00471770
Pfizer
Completed
Pneumoniae Epidemiology Study in China

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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
Not Provided
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
Not Provided
  • 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
Not Provided


*   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
Not Provided
Not Provided
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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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Contact

[email protected]



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