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

Infections, Streptococcal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01204385
• Other study ID #: 111337
• Status: Completed
• Phase: N/A
• First received: September 16, 2010
• Last updated: January 9, 2014
• Start date: June 2009
• Est. completion date: May 2011

Study information

• Verified date: January 2014
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Kingdom of Saudi Arabia: Saudi Food & Drug Authority "SFDA"
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Months to 5 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Infections, Streptococcal
• Otitis Media
• Streptococcal Infections

Intervention

Procedure:
• Sample collection
Middle ear fluid and urine

Locations

Country	Name	City	State
Saudi Arabia	GSK Investigational Site	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of H. influenzae, S. pneumoniae and other bacterial pathogens isolated from middle ear fluid samples		Average time frame: 12 months	No
Secondary	Occurence of H. influenzae and S. pneumoniae serotypes		Average time frame: 12 months	No
Secondary	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	No
Secondary	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	No
Secondary	Occurrence of spontaneous otorrhea		Average time frame: 12 months	No
Secondary	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	No
Secondary	Occurrence of H. influenzae in acute otitis media cases vaccinated with a pneumococcal vaccine		Average time frame: 12 months	No