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

NCT01204385 | Completed

• 1 other identifier: 111337
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Infections, Streptococcal

Keywords

Non-typeable Haemophilus Influenzae; Acute Otitis Media; Streptococcus Pneumoniae; etiology

Outcome Measures

Primary Outcomes (1)

• Occurrence of H. influenzae, S. pneumoniae and other bacterial pathogens isolated from middle ear fluid samples

  Average time frame: 12 months

Secondary Outcomes (6)

• 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

Study Arms (1)

Study Group

Procedure: Sample collection

Interventions

Sample collection PROCEDURE

Middle ear fluid and urine

Study Group

Eligibility Criteria

• Age: 3 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Riyadh, Saudi Arabia

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Middle ear fluid and urine

MeSH Terms

Conditions

Streptococcal Infections; Otitis Media

Interventions

Specimen Handling

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Otitis; Ear Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2010
• First Posted: September 17, 2010
• Study Start: June 1, 2009
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: January 13, 2014

Record last verified: 2014-01

Locations

SA (1)