Pneumoniae Epidemiology Study in China

Pneumococcal Disease Clinical Trial

Official title:

Epidemiological Study of Hospitalized Pediatric Pneumonia in China

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00471770
• Other study ID #: 0887X-101894
• Status: Completed
• Phase: N/A
• First received: May 8, 2007
• Last updated: March 12, 2008
• Start date: February 2007
• Est. completion date: February 2008

Study information

• Verified date: March 2008
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 60 Months

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Pneumococcal Disease

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of hospitalized pneumonia cases associated with vaccine-preventable S. Pneumoniae serotypes (4, 6B, 9V, 14, 18C, 19F, 23F).		1 year	No