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
DOI	https://doi.org/10.1186/ISRCTN85118989
Protocol serial number	947
Sponsor	Medical Research Council Laboratories (Gambia)
Funder	Medical Research Council Laboratories (Gambia)

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

Health Protection Agency Centre for Infections
61 Colindale Avenue
London
NW9 5EQ
United Kingdom

Study information

Primary study design	Interventional
Study design	Two arm randomized double blind single centre clinical trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	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.
Key secondary outcome measure(s)	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.
Completion date	02/06/2006

Eligibility

Participant type(s)	Patient
Age group	Neonate
Sex	All
Target sample size at registration	905
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

United Kingdom
England
Gambia

Study participating centre

Health Protection Agency Centre for Infections

London
NW9 5EQ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes