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Pneumoniae Epidemiology Study in China

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NCT00471770

Last updated on November 13, 2019
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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

NEED INFO?

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Pfizer Clinical Trials Contact Center

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[email protected]

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Descriptive Information
Brief TitlePneumoniae Epidemiology Study in China
Official TitleEpidemiological Study of Hospitalized Pediatric Pneumonia in China
Brief SummaryTo 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 DescriptionSubjects 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 TypeObservational
Study DesignTime Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenRetention:   Samples Without DNA
Description:
deep respiratory aspirate,pleural fluid,cerebrospinal fluid,serum
Sampling MethodNon-Probability Sample
Study PopulationHospitalized children with pneumoniae less than 5 years,located in Tianjin Children's Hospital
ConditionPneumococcal Disease
InterventionNot 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 StatusCompleted
Estimated Enrollment
 (submitted: May 8, 2007)		1000
Original Estimated EnrollmentSame as current
Actual Study Completion DateFebruary 2008
Actual Primary Completion DateFebruary 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
Agesup to 60 Months   (Child)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesChina
Removed Location Countries  
 
Administrative Information
NCT NumberNCT00471770
Other Study ID Numbers0887X-101894
Has Data Monitoring CommitteeYes
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyWyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Study SponsorWyeth is now a wholly owned subsidiary of Pfizer
CollaboratorsNot Provided
Investigators
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
PRS AccountWyeth is now a wholly owned subsidiary of Pfizer
Verification DateMarch 2008

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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