A Study to Identify and Characterise Bacteria Causing Chronic Cough Among Children in United Kingdom

Infections, Respiratory Tract Clinical Trial

Official title:

Identification and Characterisation of Bacteria Causing Chronic Cough Among Children in the United Kingdom

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01292213
• Other study ID #: 112956
• Status: Terminated
• Phase: N/A
• First received: February 3, 2011
• Last updated: September 4, 2014
• Start date: May 2012
• Est. completion date: February 2013

Study information

• Verified date: September 2014
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to investigate the role of Haemophilus influenzae and other bacteria in causing chronic cough, through a direct comparison of chronic cough cases and healthy controls recruited from paediatric respiratory clinics in the United Kingdom.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 72 Months

Eligibility

Inclusion Criteria:

• Subjects who the investigator believes that parent(s)/ legally acceptable representative can and will comply with the requirements of the protocol.

• A male or female child between, and including, six to 72 months of age at the time of enrolment.

• Written informed consent obtained from the parent(s)/ legally acceptable representative of the subject.

• No antibiotic therapy within four weeks prior to the visit.

• No cystic fibrosis or known major immunodeficiency such as agammaglobulinaemia, T cell deficiency or Human Immunodeficiency Virus / Acquired Immune Deficiency Syndrome.

• No documented evidence or suspicion of gastroesophageal reflux disease.

• No evidence of an upper viral respiratory infection four weeks prior to the visit.

In addition, all subjects regarded as 'cases' must satisfy all the following criteria at study entry:

• Persistent cough greater than eight weeks.

• No response to five-day prednisolone treatment.

• Chest X-ray showing no evidence of a lobar pneumonia or gross structural abnormality.

In addition, all subjects regarded as 'controls' must satisfy the following criteria at study entry:

• No respiratory symptoms four weeks prior to the visit.

• No documented evidence or suspicion of lung disease upon physical examination.

Exclusion Criteria:

• Concurrently participating in another study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.

• Use of any investigational or non-registered product within 30 days prior to study procedures, or planned use during the study period.

• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.

• Child in care.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Infections, Respiratory Tract
• Respiratory Tract Infections

Intervention

Procedure:
• Cough swab
Samples will be tested to determine and characterise the bacteria that may be associated with chronic cough.
• Oropharyngeal swab
Samples will be tested to determine and characterise the bacteria that may be associated with chronic cough.
• Nasopharyngeal swabs
Samples will be tested to determine and characterise the bacteria and viruses that may be associated with chronic cough.
• Blood sample
Samples will be tested to determine and characterise the immunological markers that may be associated with chronic cough.
• Bronchoscopy/ bronchoalveolar lavage samples
Samples will be tested to determine and characterise the bacteria, viruses and immunological markers that may be associated with chronic cough.

Other:
• Data collection
Questionnaire completion.

Locations

Country	Name	City	State
United Kingdom	GSK Investigational Site	Belfast
United Kingdom	GSK Investigational Site	Bristol
United Kingdom	GSK Investigational Site	Sheffield

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of Haemophilus influenzae, in the absence of co-infection with other bacteria, in the lower airways of cases and controls		12-15 months from study initiation	No
Secondary	Occurrence of Haemophilus influenzae, regardless of co-infection with other bacteria, in the lower airways of cases and controls		12-15 months from study initiation	No
Secondary	Occurrence of Streptococcus pneumoniae in the lower airways of cases and controls		12-15 months from study initiation	No
Secondary	Occurrence of Haemophilus influenzae in cough swabs and nasopharynx/ oropharynx of cases and controls		12-15 months from study initiation	No
Secondary	Occurrence of Haemophilus influenzae in the lower airways and/or nasopharynx/ oropharynx of cases and controls		12-15 months from study initiation	No
Secondary	Bacterial load of Haemophilus influenzae in the lower airways and nasopharynx/ oropharynx of cases and controls		12-15 months from study initiation	No
Secondary	Occurrence of Haemophilus haemolyticus in the lower airways and nasopharynx/ oropharynx of cases and controls		12-15 months from study initiation	No
Secondary	Antimicrobial resistance of Haemophilus influenzae in lower airways		12-15 months from study initiation	No
Secondary	Occurrence of viral pathogens in the lower airways and nasopharynx of cases and controls		12-15 months from study initiation	No
Secondary	Occurrence of Moraxella catarrhalis in the lower airways of cases and controls		12-15 months from study initiation	No
Secondary	Occurrence of other bacterial pathogens in the lower airways of cases and controls		12-15 months from study initiation	No
Secondary	Occurrence of Streptococcus pneumoniae in cough swabs and nasopharynx/ oropharynx of cases and controls		12-15 months from study initiation	No
Secondary	Occurrence of Moraxella catarrhalis in cough swabs and nasopharynx/ oropharynx of cases and controls		12-15 months from study initiation	No
Secondary	Occurrence of Streptococcus pneumoniae in the lower airways and/or nasopharynx/ oropharynx of cases and controls		12-15 months from study initiation	No
Secondary	Occurrence of other bacterial pathogens in the lower airways and/or nasopharynx/ oropharynx of cases and controls		12-15 months from study initiation	No
Secondary	Bacterial load of Streptococcus pneumoniae in the lower airways and nasopharynx/ oropharynx of cases and controls		12-15 months from study initiation	No
Secondary	Bacterial load of Moraxella catarrhalis in the lower airways and nasopharynx/ oropharynx of cases and controls		12-15 months from study initiation	No
Secondary	Occurrence of serotypes of Haemophilus influenzae in the lower airways and nasopharynx/ oropharynx of cases and controls		12-15 months from study initiation	No
Secondary	Occurrence of serotypes of Streptococcus pneumoniae in the lower airways and nasopharynx/ oropharynx of cases and controls		12-15 months from study initiation	No
Secondary	Antimicrobial resistance of Streptococcus pneumoniae in lower airways		12-15 months from study initiation	No
Secondary	Antimicrobial resistance of Moraxella catarrhalis in lower airways		12-15 months from study initiation	No