Assessment of the Natural Antibody Response to Pneumococcal Surface Proteins During Acute Otitis Media in Children
This study is currently recruiting participants.
Verified September 2011 by NasVax Ltd
Sponsor:
NasVax Ltd
Information provided by (Responsible Party):
NasVax Ltd
ClinicalTrials.gov Identifier:
NCT01214538
First received: October 3, 2010
Last updated: September 26, 2011
Last verified: September 2011
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Purpose
This clinical study is designed to assess prospectively the sero-responses to various proteins in cases of pneumococcal Acute Otitis Media.
| Condition |
|---|
|
Acute Otitis Media |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Assessment of the Natural Antibody Response to Pneumococcal Surface Proteins During Acute Otitis Media in Children |
Resource links provided by NLM:
Further study details as provided by NasVax Ltd:
Primary Outcome Measures:
- Serological studies of pneumococcal proteins and their development over time following otitis media infections [ Time Frame: 3 months per individual ] [ Designated as safety issue: No ]The serological studies will study the natural immune response to protective pneumococcal vaccine antigens.
Biospecimen Retention: Samples Without DNA
Plasma
| Estimated Enrollment: | 100 |
| Study Start Date: | October 2010 |
| Estimated Study Completion Date: | July 2014 |
| Estimated Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Control group - culture negative
50 children with pneumococcal culture-negative Acute Otitis Media
|
|
study group- culture positive
50 children with pneumococcal culture-positive Acute Otitis Media
|
Eligibility| Ages Eligible for Study: | 3 Months to 3 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
100 subjects with acute otitis media infection will be enrolled. The expectation is for ≥50 children with pneumococcal culture-positive MEF (Middle Ear Fluid) and ≥50 children with culture-negative MEF to be enrolled
Criteria
Inclusion Criteria:
- Male and female Jewish and Bedouin children.
- Patients can be either ambulatory or hospitalized.
- Presenting with acute otitis media.
- Tympanocentesis was performed at least in one ear for a clinical indication.
- Culture of middle ear fluid was obtained.
- Parents agreeing to participate in the study and to submit their children for follow-up, blood test and nasopharyngeal/oropharyngeal (NP/OP) cultures.
Exclusion Criteria:
- Having another infection that is likely to be caused by S. pneumoniae.
- Known immunodeficiency.
- Known previous recent pneumococcal infections (<1 month prior to current visit).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01214538
Locations
| Israel | |
| Ben-Gurion University of the Negev | Recruiting |
| Beer Sheva, Israel, 84101 | |
| Contact: Ron Dagan, Prof MD +972 + 8-6400547 rdagan@bgu.ac.il | |
Sponsors and Collaborators
NasVax Ltd
Investigators
| Principal Investigator: | Ron Dagan, Prof. MD. | Ben-Gurion University of the Negev |
More Information
No publications provided
| Responsible Party: | NasVax Ltd |
| ClinicalTrials.gov Identifier: | NCT01214538 History of Changes |
| Other Study ID Numbers: | NX10-07 |
| Study First Received: | October 3, 2010 |
| Last Updated: | September 26, 2011 |
| Health Authority: | Israel: Ministry of Health |
Keywords provided by NasVax Ltd:
|
Vaccine pneumococcal natural history Acute otitis media |
Additional relevant MeSH terms:
|
Otitis Otitis Media Ear Diseases Otorhinolaryngologic Diseases |
ClinicalTrials.gov processed this record on May 19, 2013