To evaluate whether a three days course of high doses of amoxicillin in the treatment of pneumonia in children is better compared to standard treatment with co-trimoxazole for five days
ISRCTN | ISRCTN85118989 |
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DOI | https://doi.org/10.1186/ISRCTN85118989 |
Secondary identifying numbers | 947 |
- Submission date
- 19/05/2010
- Registration date
- 03/06/2010
- Last edited
- 03/06/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Syed Zaman
Scientific
Scientific
Health Protection Agency Centre for Infections
61 Colindale Avenue
London
NW9 5EQ
United Kingdom
Study information
Study design | Two arm randomized double blind single centre clinical trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Participant information sheet | Not available in web format, please use contact details below to request a patient information sheet |
Scientific title | Efficacy of short course high-dose amoxicillin in the treatment of non-severe community acquired-pneumonia in children: A double-blind, randomised controlled trial |
Study acronym | HAT |
Study objectives | We hypothesised that the treatment failure in community acquired non-severe pneumonia (defined by WHO using respiratory rates) or in community acquired non-severe radiological pneumonia (defined by WHO Radiology Working Group) will be lower in children randomised to twice daily three-day oral amoxicillin 90 mg/kg-per-day (high-dose amoxicillin) compared to five-day standard dose co-trimoxazole (standard therapy). We also hypothesised that carriage of non-susceptible pneumococci to co-trimoxazole will be lower in children treated with high-dose amoxicillin compared to standard therapy. |
Ethics approval(s) | The Gambia Government / MRC Laboratories Joint Ethics Committee approved on the 23rd of June 2003 |
Health condition(s) or problem(s) studied | Community acquired pneumonia in children |
Intervention | Children randomised to high-dose amoxicillin received amoxicillin in 45 mg/kg/dose twice daily (maximum daily dose 2000 mg/day) for three days, followed by placebo twice daily for two days. Children randomised to co-trimoxazole received trimethoprim in 4 mg/kg/dose plus sulphamethoxazole in 20 mg/kg/dose twice daily for 5 days. |
Intervention type | Other |
Primary outcome measure | 1. Treatment failure: 1.1. 3 days after enrolment there was no improvement or 1.2. within 5 days after enrolment, the study drug was changed to another antibiotic, severe pneumonia or very severe disease develops, or death occurs. All children were assessed by nurses on days 3 and 5 post-enrolment. Treatment failures were confirmed by study pediatricians. |
Secondary outcome measures | 1. Relapse: Reappearance of signs of non-severe pneumonia or appearance of signs of severe pneumonia or very severe disease by day-14 post-enrolment after being declared as cured on day-5 post-enrollment. All children were assessed by nurses on days 5, 14 and 28 post-enrolment for evaluation of clinical outcomes. 2. Compliance: Proportion of children given full prescribed dosage (this was assessed by measuring left-over trial antimicrobials in the bottles on days 3 and 5). 3. Carriage rate of co-trimoxazole non-susceptible pneumococci on day-28 post-enrollment. Nasopharyngeal swab (NPS) for culture and sensitivity to antimicrobials was collected on days 0 and 28 of enrolment. |
Overall study start date | 05/03/2004 |
Completion date | 02/06/2006 |
Eligibility
Participant type(s) | Patient |
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Age group | Neonate |
Sex | Both |
Target number of participants | For community acquired pneumonia, the target number of participants was 850 children in each arm. For radiological pneumonia, the target number of participants was 55 children in each arm. |
Key inclusion criteria | 1. Aged 2 to 59 months 2. Either sex 3. Nutritional status: Weight-for-height > 70% of National Center for Health Statistics (NCHS) reference without oedema 4. Non-severe pneumonia according to WHO definition: if the child has fast breathing with cough or difficult breathing and there is no chest indrawing or other danger signs |
Key exclusion criteria | 1. Having severe pneumonia or very sever disease or if needs oxygen 2. Needed antibiotic, steroid, theophylline or digitalis for treatment of any other condition 3. Had been enrolled in the trial for an earlier episode of pneumonia 4. Was admitted in a hospital in the previous month 5. History of hypersensitivity or intolerance to amoxicillin or co-trimoxazole 6. History of receiving any antibiotic within last 48 hours, this was be confirmed from health cards or village health workers 7. A history of three or more episodes of wheeze, acute bronchial asthma 8. Evidence of underlying haematologic, renal, hepatic or cardiovascular disease 9. Chronic steroid use or concomitant treatment with theophylline or digitalis glycosides 10. Living outside the study area |
Date of first enrolment | 05/03/2004 |
Date of final enrolment | 02/06/2006 |
Locations
Countries of recruitment
- England
- Gambia
- United Kingdom
Study participating centre
Health Protection Agency Centre for Infections
London
NW9 5EQ
United Kingdom
NW9 5EQ
United Kingdom
Sponsor information
Medical Research Council Laboratories (Gambia)
Research council
Research council
PO Box 273 Banjul
Atlantic Road
Fajara
Banjul
273
Gambia
https://ror.org/025wfj672 |
Funders
Funder type
Research council
Medical Research Council Laboratories (Gambia)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |