Pneumoniae Epidemiology Study in China

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NCT00471770

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Study Location
Tianjin, , 300074, China
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Contact
1-800-718-1021
[email protected]
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FOR MORE INFORMATION

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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

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Advanced Information
Descriptive Information
Brief Title Pneumoniae Epidemiology Study in China
Official Title Epidemiological Study of Hospitalized Pediatric Pneumonia in China
Brief Summary 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).
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.
Study Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
deep respiratory aspirate,pleural fluid,cerebrospinal fluid,serum
Sampling Method Non-Probability Sample
Study Population Hospitalized children with pneumoniae less than 5 years,located in Tianjin Children's Hospital
Condition Pneumococcal Disease
Intervention Not Provided
Study 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Estimated Enrollment
 (submitted: May 8, 2007)		1000
Original Estimated Enrollment Same as current
Actual Study Completion Date February 2008
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study:All
Ages up to 60 Months   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT00471770
Other Study ID Numbers 0887X-101894
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Study Sponsor Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators Not Provided
Investigators
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date March 2008