Condition category
Respiratory
Date applied
19/05/2010
Date assigned
03/06/2010
Last edited
03/06/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Syed Zaman

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

947

Study information

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

Acronym

HAT

Study hypothesis

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

The Gambia Government / MRC Laboratories Joint Ethics Committee approved on the 23rd of June 2003

Study design

Two arm randomized double blind single centre clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

05/03/2004

Overall trial end date

02/06/2006

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Neonate

Gender

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.

Participant 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

Recruitment start date

05/03/2004

Recruitment end date

02/06/2006

Locations

Countries of recruitment

Gambia

Trial participating centre

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

Sponsor information

Organisation

Medical Research Council Laboratories (Gambia)

Sponsor details

PO Box 273 Banjul
Atlantic Road
Fajara
Banjul
273
Gambia

Sponsor type

Research council

Website

Funders

Funder type

Research council

Funder name

Medical Research Council Laboratories (Gambia)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes