Otitis Media in ChildrenMicrobiologyNCT02096848
Microbiology of Otitis Media in Costarrican Children After PCV13 Introduction
An observational study of Otitis Media in Children, run by Instituto de Atención Pediátrica at 1 site in Costa Rica.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 months to 6 years
- Conditions the study is for
- Otitis Media in Children
- How many people
- 387 participants
- Where
- 1 siteCosta Rica
- Study dates
- May 2012to Mar 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 6 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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.
Who cannot join
- 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.
- Received antibiotics for otitis media in the last day (exception: children with otitis media treatment failures must received antibiotic treatment within 3 to 5 days prior to study inclusion for the current otitis media episode).
Trial locations and contacts
1 site in 1 country.
Costa Rica1 site
Instituto de Atencion Pediatrica
San José, Provincia de San José, 1150
About this study
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).
Read the detailed description
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).
- Conditions
- Otitis Media in Children
- Keywords
- otitis media, microbiology, vaccines
- Medical subject headings
- Otitis Media
What is being measured
The primary outcome is the main question the study is designed to answer.
• 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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2014 (estimated)
- Study startMay 2012
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Otitis Media in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 387 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Atención Pediátrica
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arturo Abdelnour, Instituto de Atención Pediátrica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02096848
- Sponsor's protocol ID
- Microbiology of Otitis Media
- Acronym
- Microbiology
- Status last verified
- Sep 2016
- First submitted
- 24 Mar 2014
- Last updated
- 2 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 15999006Abdelnour 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.
PubMed 19682369
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IDENTIFICATION OF THE EFFECT OF THE PNEUMOCOCCAL CONJUGATED VACCINE IN COSTA RICA
- ClinicalTrials.gov ID
- NCT02096848
- Acronym / sponsor ID
- Microbiology / Microbiology of Otitis Media
- Conditions
- Otitis Media in Children
- Keywords
- otitis media, microbiology, vaccines
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 387 participants (actual)
- Lead sponsor
- Instituto de Atención PediátricaUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 26 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 months to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- All subjects must satisfy all the following criteria at study entry:
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
• 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.
Time frame: 3 years
• 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2016.
- Background: PubMed 15999006Arguedas 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.
- Background: PubMed 19682369Abdelnour 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Otitis Media in Children, run by Instituto de Atención Pediátrica at 1 site in Costa Rica.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Costa Rica. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• 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. (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02096848, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2016.