Microbiology of Otitis Media in Costarrican Children After PCV13 Introduction

NCT02096848 | Completed

• 1 other identifier: Microbiology of Otitis Media
• Study Type: observational
• Target: 387
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Otitis Media in Children

Keywords

otitis media; microbiology; vaccines

Outcome Measures

Primary Outcomes (1)

• • To compare the bacterial aetiology of middle ear fluid (MEF) samples collected from children with AOM following universal introduction of PCV-13 in the National Immunization Program of Costa Rica.

  • To compare the bacterial aetiology of middle ear fluid (MEF) samples collected from children with AOM following universal introduction of PCV-13 in the National Immunization Program of Costa Rica.

  3 years

Eligibility Criteria

• Age: 3 Months - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children aged more than 3 months to less than 6 years, visiting with otitis media and from whom a middle ear fluid sample has been obtained. A cohort of children with the first episode of otitis media occurring before or at the age of 24 months of age and at least one month after completion of two doses of pneumococcal 13 valent vaccine will be followed until the participant completes 36 months of life.

You may qualify if:

• All subjects must satisfy all the following criteria at study entry:
• Age: more than 3 months and less than 6 years at the time of informed consent. The subject becomes ineligible at the seven birthday.
• Signs and symptoms include:One of the functional or general signs of otalgia (or its equivalent: irritability), conjunctivitis, fever; AND EITHER Paradise's criteria (bulging, diffused or localised inflamed tympanic membranes) or Spontaneous otorrhoea of less than 24 hours.

You may not qualify if:

• Hospitalised during the diagnosis of otitis media or during treatment.
• Having an otitis externa, or otitis media with effusion
• Presence of a transtympanic tubes.
• Children presenting with a new episode of otitis media but having received antibiotic systemic therapy in the past 3 days for a separate illness.
• Receiving antimicrobial prophylaxis for recurrent acute otitis media.

Sponsors & Collaborators

• Instituto de Atención Pediátrica: lead

Study Sites (1)

Instituto de Atencion Pediatrica

San José, Provincia de San José, 1150, Costa Rica

Location

Related Publications (2)

• Arguedas A, Dagan R, Guevara S, Porat N, Soley C, Perez A, Brilla R. Middle ear fluid Streptococcus pneumoniae serotype distribution in Costa Rican children with otitis media. Pediatr Infect Dis J. 2005 Jul;24(7):631-4. doi: 10.1097/01.inf.0000168748.92510.45.

  PMID: 15999006 BACKGROUND

• Abdelnour A, Soley C, Guevara S, Porat N, Dagan R, Arguedas A. Streptococcus pneumoniae serotype 3 among Costa Rican children with otitis media: clinical, epidemiological characteristics and antimicrobial resistance patterns. BMC Pediatr. 2009 Aug 14;9:52. doi: 10.1186/1471-2431-9-52.

  PMID: 19682369 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Bacteria isolated from children with otitis media

MeSH Terms

Conditions

Otitis Media

Condition Hierarchy (Ancestors)

Otitis; Ear Diseases; Otorhinolaryngologic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD Pediatric Inmunology

Study Record Dates

• First Submitted: March 24, 2014
• First Posted: March 26, 2014
• Study Start: May 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: September 2, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)