Study to Identify and Characterize the Bacteria Causing Acute Otitis Media Episodes in Young Children in Saudi Arabia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01204385
First received: September 16, 2010
Last updated: January 9, 2014
Last verified: January 2014
  Purpose

The purpose of the study is to identify the bacterial aetiology of acute otitis media episodes in young children aged ≥ 3 months to < 5 years in Saudi Arabia.


Condition Intervention
Infections, Streptococcal
Procedure: Sample collection

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Identification and Characterization of the Bacteria Causing Acute Otitis Media (AOM) Episodes in Young Children in Saudi Arabia

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Occurrence of H. influenzae, S. pneumoniae and other bacterial pathogens isolated from middle ear fluid samples [ Time Frame: Average time frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occurence of H. influenzae and S. pneumoniae serotypes [ Time Frame: Average time frame: 12 months ] [ Designated as safety issue: No ]
  • Antimicrobial susceptibility of H. influenzae, S. pneumoniae and Moraxella catarrhalis isolated from middle ear fluid samples as assessed by standard microbiological techniques [ Time Frame: Average time frame: 12 months ] [ Designated as safety issue: No ]
  • Occurrence of treatment failure of acute otitis media and of recurrent acute otitis media (≥ 3 episodes in the last 6 months or ≥ 4 episodes in 12 months) [ Time Frame: Average time frame: 12 months ] [ Designated as safety issue: No ]
  • Occurrence of spontaneous otorrhea [ Time Frame: Average time frame: 12 months ] [ Designated as safety issue: No ]
  • Occurrence of H. influenzae in acute otitis media cases with treatment failure and in new acute otitis media cases without treatment therapy [ Time Frame: Average time frame: 12 months ] [ Designated as safety issue: No ]
  • Occurrence of H. influenzae in acute otitis media cases vaccinated with a pneumococcal vaccine [ Time Frame: Average time frame: 12 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Middle ear fluid and urine


Enrollment: 66
Study Start Date: June 2009
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Study Group
Not Applicable
Procedure: Sample collection
Middle ear fluid and urine

  Eligibility

Ages Eligible for Study:   3 Months to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects aged ≥ 3 months and < 5 years of age, diagnosed as having AOM

Criteria

Inclusion Criteria:

A child will be eligible for inclusion if he/she meets the following criteria:

  • Age: ≥ 3 months and < 5 years at the time of enrolment. The subject becomes ineligible on the fifth birthday.
  • Signs, symptoms, and conditions: i. One of the functional or general signs of otalgia (or its equivalent: irritability), conjunctivitis, fever AND EITHER ii. Paradise's criteria (bulging, diffused or localised inflamed tympanic membranes) OR iii. Spontaneous otorrhoea of less than 24 hours
  • Onset of signs and symptoms of AOM within 72 hours prior to diagnosis of AOM by a physician. To be included as treatment failure, subjects must have then received antibiotic treatment from the physician, but remain symptomatic 48-72h after initiation of treatment
  • Written informed consent obtained from parent or guardian prior to study start.

Exclusion Criteria:

The following criteria should be checked at the time of study entry. If any apply, the child must not be included in the study.

  • Hospitalised during the diagnosis of AOM or during treatment,
  • Otitis externa, or otitis media with effusion
  • Presence of a transtympanic aerator
  • Systemic antibiotic treatment received for a disease other than AOM in the 72 hours prior to enrolment,
  • Receiving antimicrobial prophylaxis for recurrent AOM,
  • Provision of antibiotic by paediatrician/ENT specialist at the enrolment visit, prior to the sampling
  • Patients on antibiotics for AOM who are clinically improving.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01204385

Locations
Saudi Arabia
GSK Investigational Site
Riyadh, Saudi Arabia
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01204385     History of Changes
Other Study ID Numbers: 111337
Study First Received: September 16, 2010
Last Updated: January 9, 2014
Health Authority: Kingdom of Saudi Arabia: Saudi Food & Drug Authority "SFDA"

Keywords provided by GlaxoSmithKline:
Non-typeable Haemophilus Influenzae
Acute Otitis Media
Streptococcus Pneumoniae
etiology

Additional relevant MeSH terms:
Otitis
Otitis Media
Streptococcal Infections
Ear Diseases
Otorhinolaryngologic Diseases
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on July 22, 2014