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STudy of Antibiotic Treatment In Children with chronic cough (STATIC)

Investigating the optimal duration of antibiotic treatment for children with a chronic wet cough

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN88611534
Enrollment
80
Registered
2015-09-28
Start date
2018-08-01
Completion date
Unknown
Last updated
2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic wet cough in children Respiratory

Interventions

Pre Treatment Visit: As part of routine investigation for chronic wet cough, the child will attend the Paediatric Day Case Unit for bronchoscopy. At this visit, the child will have bas

Sponsors

Royal Stoke University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 6 months to 10 years 2. Parent reported cough for more than 4 weeks 3. Doctor observed moist / wet cough

Exclusion criteria

Exclusion criteria: 1. Gross developmental delay 2. Cystic fibrosis 3. Ex-premature birth (<36 wks) 4. Interstitial lung disease 5. Cardiac abnormalities 6. Non cystic fibrosis bronchiectasis 7. Immunodeficiency 8. Haemoptysis 9. Penicillin allergy

Design outcomes

Primary

MeasureTime frame
Cough score will be recorded by the parent for two days prior to treatment commencing, daily during treatment and for two days after treatment completion. This validated cough scoring system correlates with objective cough counts as measured by a cough meter. It involves scoring the cough on a scale of 0-5. Cough resolution is defined as >75% reduction in the mean of the two recordings pre-treatment and the mean of the two recordings post-treatment or cessation of coughing for =3 days recorded daily during treatment. Cough score will also be recorded monthly in those who enter the 12 month follow-up as an outcome measure to assess the incidence of chronic cough relapse.

Secondary

MeasureTime frame
1. Cough Specific QoL Questionnaire: The shortened parent cough-specific QoL questionnaire (PC-QOL-8) will be used. It consists of 8 questions which are scored 1-7 and has been fully validated. It covers physical, psychological and social QoL domains. It will be measured at the pre and post treatment visits to help assess the initial response to treatment and monthly in those who enter the 12 month follow-up to assess the incidence of chronic cough relapse. 2. Lung Clearance Index (LCI): LCI is a novel form of lung function. It will be measured using an InnocorTM Gas Analyser at the pre and post treatment visits to help assess the initial response to treatment. 3. Bacterial Sequencing: All isolated organisms will be identified using standard techniques and then stored on Microbank® cryogenic beads (Pro-lab Diagnostics, UK) at -70 degrees Celsius in the RSUH Microbiology Laboratory. When a child grows the same organism from an induced sputum or cough swab during an episode of chronic cough relapse that was also identified on the bronchoscopy both samples will undergo bacterial sequencing to investigate if they are genetically identical. This will identify if relapses are caused by the same organism as the initial episode. 4. Blood Markers of Bacterial Inflammation and Asthma / Atopy: At the pre-treatment visit blood samples will be taken for full blood count, total IgE, CC16, IL-5 and procalcitonin. The first four of these can be used as markers of asthma / atopy. We hypothesise that children who do not respond to antibiotics will have evidence of asthma / atopy suggesting an alternative diagnosis. Procalcitonin is a sensitive marker of bacterial induced inflammation. It can be used to predict if children with community acquired pneumonia will or will not respond to antibiotic treatment. We hypothesise that children who do not respond to antibiotics will have low levels of procalcitonin suggesting there is no bacterial

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026