Status:
COMPLETED
Trial on the Ideal Duration of Oral Antibiotics in Children With Pneumonia
Lead Sponsor:
University of Malaya
Collaborating Sponsors:
Menzies School of Health Research
Conditions:
Pneumonia
Eligibility:
All Genders
3-59 years
Phase:
PHASE4
Brief Summary
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 outcom...
Detailed Description
Introduction: Pneumonia is the single largest cause of death in children less than 5 years old and these are preventable deaths.\[1,2\] It is also an important cause of morbidity , especially when it...
Eligibility Criteria
Inclusion
- 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
- 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
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Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2018
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT02258763
Start Date
November 1 2014
End Date
October 1 2018
Last Update
April 23 2019
Active Locations (1)
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1
University Malaya Medical Centre
Kuala Lumpur, Lembah Pantai, Malaysia, 59100