Trial on the Ideal Duration of Oral Antibiotics in Children With Pneumonia

• Status: Completed
• Trial end date: 2018-10-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Malaya
• Collaborator: Menzies School of Health Research
• Treatments: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Antibiotics, Antitubercular; Clavulanic Acid; Clavulanic Acids

Criteria

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

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