Ignite Creation Date:
2024-05-05 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00471770
Status:
COMPLETED
Last Update Posted:
2008-03-13
First Post:
2007-05-08
Brief Title:
Pneumoniae Epidemiology Study in China
Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Organization:
Wyeth is now a wholly owned subsidiary of Pfizer
Study Overview
Official Title:
Epidemiological Study of Hospitalized Pediatric Pneumonia in China
Status:
COMPLETED
Status Verified Date:
2008-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None