A Study to Identify and Characterise Bacteria Causing Chronic Cough Among Children in United Kingdom
Terminated
- Conditions
- Infections, Respiratory Tract
- Interventions
- Procedure: Cough swabProcedure: Oropharyngeal swabProcedure: Nasopharyngeal swabsProcedure: Blood sampleProcedure: Bronchoscopy/ bronchoalveolar lavage samplesOther: Data collection
- Registration Number
- NCT01292213
- Lead Sponsor
- GlaxoSmithKline
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 19
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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cases Oropharyngeal swab Subjects diagnosed with chronic cough who are undergoing general anaesthesia and bronchoscopy/BAL as part of the diagnostic process for chronic cough. Cases Nasopharyngeal swabs Subjects diagnosed with chronic cough who are undergoing general anaesthesia and bronchoscopy/BAL as part of the diagnostic process for chronic cough. Cases Blood sample Subjects diagnosed with chronic cough who are undergoing general anaesthesia and bronchoscopy/BAL as part of the diagnostic process for chronic cough. Controls Cough swab Subjects without respiratory symptoms who are undergoing general anaesthesia for elective surgery or endoscopy of non-respiratory-related conditions. Controls Nasopharyngeal swabs Subjects without respiratory symptoms who are undergoing general anaesthesia for elective surgery or endoscopy of non-respiratory-related conditions. Controls Data collection Subjects without respiratory symptoms who are undergoing general anaesthesia for elective surgery or endoscopy of non-respiratory-related conditions. Cases Cough swab Subjects diagnosed with chronic cough who are undergoing general anaesthesia and bronchoscopy/BAL as part of the diagnostic process for chronic cough. Controls Blood sample Subjects without respiratory symptoms who are undergoing general anaesthesia for elective surgery or endoscopy of non-respiratory-related conditions. Controls Bronchoscopy/ bronchoalveolar lavage samples Subjects without respiratory symptoms who are undergoing general anaesthesia for elective surgery or endoscopy of non-respiratory-related conditions. Cases Data collection Subjects diagnosed with chronic cough who are undergoing general anaesthesia and bronchoscopy/BAL as part of the diagnostic process for chronic cough. Cases Bronchoscopy/ bronchoalveolar lavage samples Subjects diagnosed with chronic cough who are undergoing general anaesthesia and bronchoscopy/BAL as part of the diagnostic process for chronic cough. Controls Oropharyngeal swab Subjects without respiratory symptoms who are undergoing general anaesthesia for elective surgery or endoscopy of non-respiratory-related conditions.
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method Bacterial load of Haemophilus influenzae in the lower airways and nasopharynx/ oropharynx of cases and controls 12-15 months from study initiation Occurrence of Haemophilus influenzae in cough swabs and nasopharynx/ oropharynx of cases and controls 12-15 months from study initiation Occurrence of Haemophilus influenzae in the lower airways and/or nasopharynx/ oropharynx of cases and controls 12-15 months from study initiation Antimicrobial resistance of Haemophilus influenzae in lower airways 12-15 months from study initiation Occurrence of Streptococcus pneumoniae in the lower airways and/or nasopharynx/ oropharynx of cases and controls 12-15 months from study initiation Bacterial load of Streptococcus pneumoniae in the lower airways and nasopharynx/ oropharynx of cases and controls 12-15 months from study initiation Occurrence of Haemophilus haemolyticus in the lower airways and nasopharynx/ oropharynx of cases and controls 12-15 months from study initiation Occurrence of Streptococcus pneumoniae in the lower airways of cases and controls 12-15 months from study initiation Occurrence of other bacterial pathogens in the lower airways of cases and controls 12-15 months from study initiation Bacterial load of Moraxella catarrhalis in the lower airways and nasopharynx/ oropharynx of cases and controls 12-15 months from study initiation Occurrence of serotypes of Haemophilus influenzae in the lower airways and nasopharynx/ oropharynx of cases and controls 12-15 months from study initiation 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 Occurrence of Moraxella catarrhalis in the lower airways of cases and controls 12-15 months from study initiation Occurrence of Streptococcus pneumoniae in cough swabs and nasopharynx/ oropharynx of cases and controls 12-15 months from study initiation Occurrence of other bacterial pathogens in the lower airways and/or nasopharynx/ oropharynx of cases and controls 12-15 months from study initiation Antimicrobial resistance of Moraxella catarrhalis in lower airways 12-15 months from study initiation Occurrence of viral pathogens in the lower airways and nasopharynx of cases and controls 12-15 months from study initiation Occurrence of Moraxella catarrhalis in cough swabs and nasopharynx/ oropharynx of cases and controls 12-15 months from study initiation Occurrence of serotypes of Streptococcus pneumoniae in the lower airways and nasopharynx/ oropharynx of cases and controls 12-15 months from study initiation Antimicrobial resistance of Streptococcus pneumoniae in lower airways 12-15 months from study initiation
Trial Locations
- Locations (1)
GSK Investigational Site
🇬🇧Sheffield, United Kingdom