Pneumonia Clinical Trial
Official title:
Pneumonia in Children: Aetiology, Ideal Antibiotic Duration, Quality of Life
Verified date | April 2019 |
Source | University of Malaya |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To determine, in children hospitalized with pneumonia, if an extended duration of oral
antibiotics (10 days) will be superior to a shorter duration (3 days) of antibiotics in
improving clinical outcomes.
Secondary Aims:
1. Describe the prevalence of respiratory viruses and bacteria at presentation.
2. Investigate the depression, anxiety and stress scores (DASS21) and quality of life
scored (QOL) by parents of the children during admission, pre-discharge and post
discharge and at follow-ups.
Status | Completed |
Enrollment | 19 |
Est. completion date | October 2018 |
Est. primary completion date | November 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Months to 59 Months |
Eligibility |
Inclusion Criteria: Children admitted with severe pneumonia as defined by the presence of all the following as defined as below: - 3 months to 59 months old - History of cough and/or shortness of breath - Unwell for <= 7 days -Increased respiratory rate ( = 50/min if =12 months old, = 40/min) or retractions,- - Any of the following signs/symptoms are present at examination that would necessitate admission: chest retractions, cyanosis, saturation< 92% on air, poor feeding or lethargy - Documented fever (axillary /central temp = 38/38.5°C) within 24 hrs of admission - Abnormal CXR with presence of alveolar infiltrates - Responds to IV antibiotics by the first 72 hrs and able to go home with oral antibiotics i.e. no more hypoxia and afebrile and reduced respiratory symptoms Exclusion Criteria: Children who (a) are transferred from another hospital (b) refuse blood taking (c) have a doctor diagnosis of asthma or recurrent wheezing illness (d) have a diagnosis of bronchiolitis i.e. wheezing in a child with a CXR with no consolidation (e) not acute illness ( ie >7 days) (f) unable to come for follow-up (g) not community acquired pneumonia e.g. aspiration pneumonia (h)complicated pneumonia with effusion, pneumothorax, clinical suspicion of necrotizing pneumonia (i)PICU admission or use of Non-invasive ventilation (j)significant comorbidities that can increase the risk of having a complicated pneumonia- (k) need for use of other antibiotics like anti-staph or macrolides (l)extra-pulmonary infection e.g. meningitis (m)allergy to penicillin (n) unable to tolerate oral antibiotics (o) underlying illness that can predispose to recurrent pneumonia |
Country | Name | City | State |
---|---|---|---|
Malaysia | University Malaya Medical Centre | Kuala Lumpur | Lembah Pantai |
Lead Sponsor | Collaborator |
---|---|
University of Malaya | Menzies School of Health Research |
Malaysia,
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* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Cost effective analysis of long vs short course of antibiotics for pneumonia | To see if the extended antibiotic course is cost effective | at the 4 weeks appointment | |
Primary | Clinical cure | Complete resolution of symptoms. No treatment failure or exit failure i.e. need for antibiotics or readmission into hospital for a respiratory condition | 30 days | |
Secondary | Quality of life of child and parent | Severity of cough by using the translated and validated PCQOL-8 to assess impact of cough on the child and parent. | on admission, at discharge, at follow-ups( 4 weeks, 6 months and 1 year) | |
Secondary | Impact of pneumonia on the parent | Using the translated and validated DASS21 on parents | on admission, at discharge, at follow-ups(average 1 week, 4 weeks, 6 months and 1 year) | |
Secondary | Severity of pneumonia | Using the translated and validated the Canadian Acute Respiratory Influenza Scale(CARIFS) | during the admission which expected duration will be 5 days, daily twice a day to do the questionnaires | |
Secondary | Adverse effects | Treatment related adverse effects of antibiotics e.g. diarrhoea, vomiting | at 4 weeks follow-up | |
Secondary | Time to next hospitalisation or visit to healthcare unit | Time to the next hospitalization or visit to the doctor for respiratory symptoms | during the one year post pneumonic episode; patient will be seen on an avearge of 1 week, 4 weeks, 6 months and 1 year | |
Secondary | Number hospitalised for pneumonia or unscheduled healthcare visits | proportion of children hospitalised for respiratory illness or need for unscheduled healthcare visits | during the one year post pneumonic episode; patient will be seen on an avearge of 1 week, 4 weeks, 6 months and 1 year | |
Secondary | Bacterial isolates | Bacterial isolates: resistance pattern, resolution or persistence. Viral isolates: positive or negative These will be assessed at admission and 4 weeks post-discharge | at the 4 weeks appointment | |
Secondary | Radiological resolution | Radiological resolution and correlation with respiratory symptoms | at the 4 weeks appointment | |
Secondary | Prevalence of chronic respiratory symptoms and signs post pneumonia | Presence of respiratory symptoms and signs e.g. cough, failure to thrive, reduced effort tolerance, clubbing, persistent respiratory signs | during the one year post pneumonic episode; patient will be seen on an avearge of 1 week, 4 weeks, 6 months and 1 yea | |
Secondary | Severity of cough during 4 weeks post-discharge | Using the visual scale cough diary | at the 4 weeks appointment, cough diary which will be done by parents daily from discharge |
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