Clinical trial NCT00471770: Pneumoniae Epidemiology Study in China
Official title: Epidemiological Study of Hospitalized Pediatric Pneumonia in China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pneumococcal Disease
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-05-10
Enrollment: 1000
Sex: ALL
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospitalized children with pneumoniae less than 5 years,located in Tianjin Children's Hospital

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.

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

Primary outcomes:
measure: The proportion of hospitalized pneumonia cases associated with vaccine-preventable S. Pneumoniae serotypes (4, 6B, 9V, 14, 18C, 19F, 23F).
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Tianjin
country: China
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References: