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
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

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

Study information

Study designTwo arm randomized double blind single centre clinical trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use contact details below to request a patient information sheet
Scientific titleEfficacy of short course high-dose amoxicillin in the treatment of non-severe community acquired-pneumonia in children: A double-blind, randomised controlled trial
Study acronymHAT
Study objectivesWe 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) studiedCommunity acquired pneumonia in children
InterventionChildren 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 typeOther
Primary outcome measure1. 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 measures1. 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 date05/03/2004
Completion date02/06/2006

Eligibility

Participant type(s)Patient
Age groupNeonate
SexBoth
Target number of participantsFor 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 criteria1. 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 criteria1. 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 enrolment05/03/2004
Date of final enrolment02/06/2006

Locations

Countries of recruitment

  • England
  • Gambia
  • United Kingdom

Study participating centre

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

Sponsor information

Medical Research Council Laboratories (Gambia)
Research council

PO Box 273 Banjul
Atlantic Road
Fajara
Banjul
273
Gambia

ROR logo "ROR" https://ror.org/025wfj672

Funders

Funder type

Research council

Medical Research Council Laboratories (Gambia)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan