ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- 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
- 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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Descriptive Information | ||||
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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 |
| |||
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 | 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:
Exclusion Criteria:
| |||
Sex/Gender |
| |||
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 |
| |||
PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Verification Date | March 2008 |