A study looking at how best to treat young children with chest infections.
- Conditions
- PneumoniaTherapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2016-000809-36-IE
- Lead Sponsor
- niversity College London
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 800
The inclusion criteria are different for the patients recruited from PED and from the WARD settings therefore these have been displayed here separately.
PED Group:
1. Age greater than 6 months and weighing 6 - 24kg
2. Clinical diagnosis of CAP at presentation to PED as defined by all the following:
? - Presence of cough (reported by parents/guardians in last 96 hours) AND
? - Temperature =38oC measured by any method or likely fever in last 48 hours AND
? - Signs of laboured/difficult breathing or focal chest signs at presentation in the PED (i.e. one or more of the following):
o Nasal flaring
o Chest retractions
o Abdominal breathing
o Focal dullness to percussion
o Focal reduced breath sounds
o Crackles with asymmetry
o Lobar pneumonia on chest X-ray (if obtained)
3. Prior antibiotic treatment:
o Not on systemic antibiotic treatment at presentation OR
o Treated in the community as an outpatient with uninterrupted oral beta-lactam antibiotics for = 48 hours
4. Decision to treat with oral amoxicillin for CAP on discharge from hospital
5. Parent/guardian willing to accept all possible randomised allocations
6. Available for follow-up for the entire study period, parent/guardian willing to be contacted by telephone at day 4, weeks 1, 2 and 3, and attend a face-to-face follow up visit at 4 weeks after randomisation, unless discuss with MRC CTU
7. Informed consent form for trial participation signed by parent/guardian.
WARD:
1. Age greater than 6 months and weighing 6 - 24kg
2. Clinical diagnosis of CAP at presentation to hospital as defined by all the following:
? - Presence of cough (reported by parents/guardians in last 96 hours) AND
? - Temperature =38oC measured by any method or likely fever in last 48 hours AND
? - Signs of laboured/difficult breathing or focal chest signs at presentation in the PED (i.e. one or more of the following):
o Nasal flaring
o Chest retractions
o Abdominal breathing
o Focal dullness to percussion
o Focal reduced breath sounds
o Crackles with asymmetry
o Lobar pneumonia on chest X-ray (if obtained)
3. Prior antibiotic treatment including doses administered in hospital:
? - Treated in-hospital only with any oral or intravenous beta-lactam for =48 hours after admission
? - Treated initially in the community and subsequently in hospital with any oral or intravenous beta-lactam, without interruption, for =48 hours in total
4. Decision to further treat with oral amoxicillin for CAP on discharge from hospital
5. Child is considered fit for discharge at time of randomisation
6. Available for follow-up for the entire study period, parent/guardian willing to be contacted by telephone at weeks 1, 2 and 3 and attend face-to-face follow up visit at 4 weeks after randomisation, unless discussed with MRC CTU
7. Parent/guardian willing to accept all possible randomised allocations
8. Informed consent for trial participation signed by a parent/guardian
Are the trial subjects under 18? yes
Number of subjects for this age range: 800
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
The exclusion criteria are different for the patients recruited from PED and from the WARD settings therefore these have been displayed here separately.
PED Group:
1. Severe underlying chronic disease including sickle cell anaemia, primary or secondary immunodeficiency, chronic lung disease and cystic fibrosis
2. Documented penicillin allergy
3. Any other known contra-indication to amoxicillin
4. Need for systemic treatment with an antibiotic other than amoxicillin on discharge from hospital
5. Bilateral wheezing without focal chest signs (most likely to represent respiratory tract infection of non-bacterial aetiology)
6. Complicated pneumonia
7. Receipt of initial antibiotic treatment as inpatient in PAU or on the ward
8. Parents/guardians unlikely to reliably complete the diary because of significant language barriers.
WARD:
1. Severe underlying chronic disease including sickle cell anaemia, primary or secondary immunodeficiency, chronic lung disease and cystic fibrosis
2. Documented penicillin allergy
3. Any other known contra-indication to taking amoxicillin
4. Bilateral wheezing without focal chest signs (most likely to represent respiratory tract infection of non-bacterial aetiology)
5. Complicated pneumonia
6. Receipt of antibiotic other than a beta-lactam during admission
7. If treated in the community prior to admission, receipt of a non-beta lactam antibiotic in the community at presentation
8. Clinically relevant positive blood culture (i.e. positive blood culture and clinical decision to prolong intravenous treatment for more than 48 hours or inappropriate to switch to amoxicillin therapy)
9. Receipt of >48 hours oral or intravenous inpatient antibiotic treatment
10. Decision to treat with oral antibiotic other than amoxicillin on discharge from hospital
11. Parents/guardians unlikely to reliably complete the diary because of significant language barriers.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method