Efficacy, safety and impact on antimicrobial resistance of duration and dose of amoxicillin treatment for young children with Community-Acquired Pneumonia (CAP): a randomised controlled trial. - CAP-IT
- Conditions
- PneumoniaTherapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2016-000809-36-GB
- Lead Sponsor
- Medical Research Council Clinical Trials Unit at UC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 824
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 from 1 to 5 years (up to their 6th birthday)
2. Clinical diagnosis of CAP 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 history of fever in last 24 hours reported by parents/guardians 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
3. Decision to treat with oral amoxicillin for CAP on discharge from hospital
4. Parent/guardian willing to accept all possible randomised allocations
5. 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
6. Informed consent form for trial participation signed by parent/guardian.
WARD:
1. Age from 1 to 5 years (up to their 6th birthday)
2. Clinical diagnosis of CAP as defined by the all the following :
o Presence of cough (reported by parents/guardians in last 96 hours) AND;
o Temperature =38oC measured by any method or history of fever in last 24 hours reported by parents/guardians AND;
o Signs of laboured/difficult breathing or focal chest signs (i.e. one or more of the following):
? Nasal flaring
? Chest retractions
? Abdominal breathing
? Focal dullness to percussion
? Focal reduced breath sounds
? Crackles with asymmetry
3. Admitted to a paediatric assessment unit or inpatient ward at a participating hospital
4. Treated with any oral or intravenous beta-lactam for =48 hours after admission
5. Decision to further treat with oral amoxicillin for CAP
6. Planned for discharge and to continue uninterrupted antibiotic treatment.
7. 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.
8. Parent/guardian willing to accept all possible randomised allocations
9. Informed consent for trial participation signed by a parent/guardian
Are the trial subjects under 18? yes
Number of subjects for this age range: 2400
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. On systemic antibiotic treatment at presentation
5. Bilateral wheezing without focal chest signs (most likely to represent respiratory tract infection of non-bacterial aetiology)
6. Complicated pneumonia
7. Initial decision to treat with oral antibiotic other than amoxicillin on discharge from hospital
8. Receipt of initial antibiotic treatment as inpatient in PAU or on the ward*
9. Weight >24kg
10. 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. Already on systemic antibiotic treatment at presentation
5. Bilateral wheezing without focal chest signs (most likely to represent respiratory tract infection of non-bacterial aetiology)
6. Complicated pneumonia
7. Receipt of antibiotic other than a beta-lactam during admission
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. Current oxygen requirement
10. Current age-specific tachypnoea
11. Receipt of >48 hours oral or intravenous inpatient antibiotic treatment
12. Decision to treat with oral antibiotic other than amoxicillin on discharge from hospital
13. Weight >24kg
14. 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