Otitis Media in Children Clinical Trial
Official title:
IDENTIFICATION OF THE EFFECT OF THE PNEUMOCOCCAL CONJUGATED VACCINE IN COSTA RICA
Studies which describe the bacterial aetiology and antimicrobial susceptibility in AOM
children in Latin America are scarce. Interestingly, when the MEF microbiology was analyzed
among 1,108 children aged 2-92 months with OM between years 2002 and 2007, non-typable H.
influenzae was the most common pathogen isolated from the MEF of children with a otitis
media failing to appropriate antimicrobial therapy.
PCV-7 (3 + 1 regimen) was introduced into the Costa Rican national immunization program in
January 2009 and in August/September of 2011, it was changed for PCV 13 (-2+1 regimen).
Following PCV-7 universal introduction in Costa Rica, between March of 2010 and January of
2011, MEF samples from Costa Rican children with OM, having received 0-4 PCV 7 vaccine
doses, were obtained via tympanocentesis (88%) or from spontaneous otorrhoea (12%). It was
interesting to observed that among the initial 134 OM episodes, the most common bacterial
pathogen identified was H. influenzae (55%) followed by S. pneumoniae (31%) and that among
the S. pneumoniae episodes, 55% were already non-PCV-7 serotypes and that 25% of these
isolates were multi-drug resistant.
The primary objectives of the study are to analyze the effect of early universal utilization
of PCV-13 in Costa Rican children with the number of H. influenzae and PCV-13- S. pneumoniae
positive MEF cultures by comparing the data collected prospectively and by the same group of
investigators that have collected the original data since 1992, from children for the
post-PCV-13 introduction with anonymised information collected retrospectively pre-PCV-7
data (1999-2004) during a transition period in which PCV-7 was used in only the private
settings (2005-2008) and during universal use of PCV-7 (2009-September 2011).
Studies which describe the bacterial aetiology and antimicrobial susceptibility in AOM
children in Latin America are scarce, however, since 1991, investigators in Costa Rica have
follow the MEF microbiology of Costa Rican children with AOM including data before PCV 7,
during a period of time when PCV-7 was used among high risk children and after universal
introduction of a 3 + 1 PCV-7 regimen in Costa Rica. Published data from Costa Rican
children with OM, collected between 1992 and 2007, describing the MEF microbiology indicated
that overall S. pneumoniae was the most frequent pathogen followed by non-typable H.
influenzae, M. catarrhalis and S. pyogenes. Interestingly, when the MEF microbiology was
analyzed among 1,108 children aged 2-92 months with OM between years 2002 and 2007,
non-typable H. influenzae was the mosto common pathogen isolated from the MEF of children
with a otitis media failing to appropriate antimicrobial therapy.
PCV-7 (3 + 1 regimen) was introduced into the Costa Rican national immunization program in
January 2009 and in August/September of 2011, it was changed for PCV 13 (-2+1 regimen).
Following PCV-7 universal introduction in Costa Rica, between March of 2010 and January of
2011, MEF samples from Costa Rican children with OM, having received 0-4 PCV 7 vaccine
doses, were obtained via tympanocentesis (88%) or from spontaneous otorrhoea (12%). It was
interesting to observed that among the initial 134 OM episodes, the most common bacterial
pathogen identified was H. influenzae (55%) followed by S. pneumoniae (31%) and that among
the S. pneumoniae episodes, 55% were already non-PCV-7 serotypes and that 25% of these
isolates were multi-drug resistant.
Based on the available information describing the worldwide modifications in the MEF
microbiology of PCV-7 vaccinated children with OM (a proportional increase of cases caused
by H. influenzae and non-PCV-7 S. pneumoniae serotypes), the primary objectives of the study
are to analyze the effect of early universal utilization of PCV-13 in Costa Rican children
with the number of H. influenzae and PCV-13- S. pneumoniae positive MEF cultures by
comparing the data collected prospectively and by the same group of investigators that have
collected the original data since 1992, from children for the post-PCV-13 introduction with
anonymised information collected retrospectively pre-PCV-7 data (1999-2004) during a
transition period in which PCV-7 was used in only the private settings (2005-2008) and
during universal use of PCV-7 (2009-September 2011).
;
Observational Model: Cohort, Time Perspective: Prospective
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06191562 -
Posterior vs. Anterior Tympanostomy Tube Placement
|
N/A |