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

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ClinicalTrials.gov Identifier: NCT02258763
Recruitment Status : Completed
First Posted : October 7, 2014
Last Update Posted : April 23, 2019
Sponsor:
Collaborator:
Menzies School of Health Research
Information provided by (Responsible Party):
Anna Marie Nathan, University of Malaya

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 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.

Condition or disease Intervention/treatment Phase
Pneumonia Drug: Amoxicillin-Potassium Clavulanate Combination Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pneumonia in Children: Aetiology, Ideal Antibiotic Duration, Quality of Life
Study Start Date : November 2014
Actual Primary Completion Date : November 2017
Actual Study Completion Date : October 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Amoxicillin-Potassium Clavulanate
Patient will be on amoxicillin-clavulanate 22.5mg/kg/dose bd for 10 days
Drug: Amoxicillin-Potassium Clavulanate Combination
Oral antibiotic for 10 days
Other Names:
  • Augmentin
  • Clomovid
  • Co-amoxiclav

Active Comparator: Placebo
Patient will be on amoxicillin-clavulanate 22.5mg/kg/bd for 3 days followed by another 7 days of placebo medication given at the same dose and frequency
Drug: Amoxicillin-Potassium Clavulanate Combination
Oral antibiotic for 10 days
Other Names:
  • Augmentin
  • Clomovid
  • Co-amoxiclav

Drug: Placebo
Placebo made to look like the study drug-main ingredient sugar syrup made by the pharmacy department in the hospital In the placebo arm, patient will be given 3 days of antibiotic followed by 7 days of placebo
Other Name: Placebo arm




Primary Outcome Measures :
  1. Clinical cure [ Time Frame: 30 days ]
    Complete resolution of symptoms. No treatment failure or exit failure i.e. need for antibiotics or readmission into hospital for a respiratory condition


Secondary Outcome Measures :
  1. Quality of life of child and parent [ Time Frame: on admission, at discharge, at follow-ups( 4 weeks, 6 months and 1 year) ]
    Severity of cough by using the translated and validated PCQOL-8 to assess impact of cough on the child and parent.

  2. Impact of pneumonia on the parent [ Time Frame: on admission, at discharge, at follow-ups(average 1 week, 4 weeks, 6 months and 1 year) ]
    Using the translated and validated DASS21 on parents

  3. Severity of pneumonia [ Time Frame: during the admission which expected duration will be 5 days, daily twice a day to do the questionnaires ]
    Using the translated and validated the Canadian Acute Respiratory Influenza Scale(CARIFS)

  4. Adverse effects [ Time Frame: at 4 weeks follow-up ]
    Treatment related adverse effects of antibiotics e.g. diarrhoea, vomiting

  5. Time to next hospitalisation or visit to healthcare unit [ Time Frame: during the one year post pneumonic episode; patient will be seen on an avearge of 1 week, 4 weeks, 6 months and 1 year ]
    Time to the next hospitalization or visit to the doctor for respiratory symptoms

  6. Number hospitalised for pneumonia or unscheduled healthcare visits [ Time Frame: during the one year post pneumonic episode; patient will be seen on an avearge of 1 week, 4 weeks, 6 months and 1 year ]
    proportion of children hospitalised for respiratory illness or need for unscheduled healthcare visits

  7. Bacterial isolates [ Time Frame: at the 4 weeks appointment ]
    Bacterial isolates: resistance pattern, resolution or persistence. Viral isolates: positive or negative These will be assessed at admission and 4 weeks post-discharge

  8. Radiological resolution [ Time Frame: at the 4 weeks appointment ]
    Radiological resolution and correlation with respiratory symptoms

  9. Prevalence of chronic respiratory symptoms and signs post pneumonia [ Time Frame: during the one year post pneumonic episode; patient will be seen on an avearge of 1 week, 4 weeks, 6 months and 1 yea ]
    Presence of respiratory symptoms and signs e.g. cough, failure to thrive, reduced effort tolerance, clubbing, persistent respiratory signs

  10. Severity of cough during 4 weeks post-discharge [ Time Frame: at the 4 weeks appointment, cough diary which will be done by parents daily from discharge ]
    Using the visual scale cough diary


Other Outcome Measures:
  1. Cost effective analysis of long vs short course of antibiotics for pneumonia [ Time Frame: at the 4 weeks appointment ]
    To see if the extended antibiotic course is cost effective



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Months to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02258763


Locations
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Malaysia
University Malaya Medical Centre
Kuala Lumpur, Lembah Pantai, Malaysia, 59100
Sponsors and Collaborators
University of Malaya
Menzies School of Health Research

Publications of Results:

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Responsible Party: Anna Marie Nathan, Consultant and Associate Professor, University of Malaya
ClinicalTrials.gov Identifier: NCT02258763    
Other Study ID Numbers: RP026-14HTM
First Posted: October 7, 2014    Key Record Dates
Last Update Posted: April 23, 2019
Last Verified: April 2019
Keywords provided by Anna Marie Nathan, University of Malaya:
Pneumonia
Child
Outcome
Antibiotics
Etiology
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Anti-Bacterial Agents
Amoxicillin
Clavulanic Acid
Clavulanic Acids
Amoxicillin-Potassium Clavulanate Combination
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action