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

Identification and Characterization of the Bacteria Causing Acute Otitis Media (AOM) Episodes in Young Children in Saudi Arabia

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.

Study Overview

• Status: Completed
• Conditions: Infections, Streptococcal
• Intervention / Treatment: Procedure: Sample collection

• Study Type: Observational
• Enrollment (Actual): 66

Contacts and Locations

Study Locations

• Saudi Arabia
  • Riyadh, Saudi Arabia
    • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 5 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Study Group	Procedure: Sample collection; Middle ear fluid and urine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Occurrence of H. influenzae, S. pneumoniae and other bacterial pathogens isolated from middle ear fluid samples	Average time frame: 12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Occurence of H. influenzae and S. pneumoniae serotypes	Average time frame: 12 months
Antimicrobial susceptibility of H. influenzae, S. pneumoniae and Moraxella catarrhalis isolated from middle ear fluid samples as assessed by standard microbiological techniques	Average time frame: 12 months
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)	Average time frame: 12 months
Occurrence of spontaneous otorrhea	Average time frame: 12 months
Occurrence of H. influenzae in acute otitis media cases with treatment failure and in new acute otitis media cases without treatment therapy	Average time frame: 12 months
Occurrence of H. influenzae in acute otitis media cases vaccinated with a pneumococcal vaccine	Average time frame: 12 months

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (ACTUAL): May 1, 2011
• Study Completion (ACTUAL): May 1, 2011

Study Registration Dates

• First Submitted: September 16, 2010
• First Submitted That Met QC Criteria: September 16, 2010
• First Posted (ESTIMATE): September 17, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): January 13, 2014
• Last Update Submitted That Met QC Criteria: January 9, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: Non-typeable Haemophilus Influenzae; Acute Otitis Media; Streptococcus Pneumoniae; etiology
• Additional Relevant MeSH Terms: Infections; Otorhinolaryngologic Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Ear Diseases; Otitis; Otitis Media; Streptococcal Infections
• Other Study ID Numbers: 111337