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

September 16, 2010
January 9, 2014
June 2009
May 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01204385 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Middle ear fluid and urine

Non-Probability Sample

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

Infections, Streptococcal
Procedure: Sample collection
Middle ear fluid and urine
Study Group
Not Applicable
Intervention: Procedure: Sample collection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
66
May 2011
May 2011   (final data collection date for primary outcome measure)

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.
Both
3 Months to 5 Years
No
Contact information is only displayed when the study is recruiting subjects
Saudi Arabia
 
NCT01204385
111337
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP