Duration of Antimicrobial Therapy for Paediatric Pneumonia

Pneumonia Clinical Trial

Official title:

Short Course Antimicrobial Therapy for Paediatric Community-Acquired Pneumonia: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01707485
• Other study ID #: NIF-12303
• Status: Completed
• Phase: Phase 4
• Start date: November 2012
• Est. completion date: May 2014

Study information

• Verified date: February 2021
• Source: Hamilton Health Sciences Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will investigate the feasibility of testing whether a 5-day course of antibiotics is as effective as a 10-day course for the treatment of uncomplicated community-acquired pneumonia (CAP) in children. To accomplish this, previously well children aged 1-10 years who present to McMaster Children's Hospital (MCH) emergency department (ED) with CAP will, if they consent, be randomly chosen to be given either a 5 day or 10 day course of amoxicillin. Neither the child, the child's caregiver, nor the researchers will know whether the child is in the 5- or 10-day antibiotic group. Once the child has received the medication and for two weeks after that, caregivers of children will be asked to complete a daily symptom diary for their child, and will come to MCH at the end of the two week period (between day 14-18) to be assessed by one of the researchers. This information will then be used to compare both groups of children to determine if a 5 days of treatment is non-inferior to 10 days. The investigators hypothesize that running such a trial is feasible.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 10 Years

Eligibility

Inclusion Criteria:

• children aged 1-10 y presenting to the emergency department
• must fulfil definition of 'pneumonia', ie.

1) any one of:

• fever in the ED,
• a recorded fever at home in the 48h prior to presentation, or
• WBC > 12 or WBC < 5 in the ED;

2) any one of:

• tachypnoea on exam;
• cough on exam or by history;
• increased work of breathing on exam; or
• auscultatory findings consistent with pneumonia; 3) a lobar consolidation on chest radiograph as judged by the ED physician; and 4) the attending ED physician diagnoses the child with primary CAP
• well enough to be discharged home from the emergency

Exclusion Criteria:

• 2 or more episodes of emesis in the emergency
• history of CF, anatomic lung disease, bronchiectasis, congenital heart disease, repeated aspirations, malignancy, immune suppression, recent prolonged admission to hospital, pneumonia diagnosed within the last month, lung abscess within the past six months, > 24 hours of beta-lactam antibiotic therapy prior to presentation, allergy to penicillin, allergy to food colouring
• evidence of empyaema or necrotizing pneumonia on chest radiograph

Related Conditions & MeSH terms

• Pneumonia

Intervention

Drug:
• amoxicillin
dosed 75-100 mg/kg/day (standardized dosing)

Locations

Country	Name	City	State
Canada	McMaster Children's Hospital	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical cure	Resolution of symptoms and signs of pneumonia.	14-18 days post-randomization
Secondary	absentee days		14 d post-randomization
Secondary	number of days of adverse reactions		14 d post randomization