Community acquired pneumonia in children Respiratory
Conditions
Interventions
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 r
Sponsors
Medical Research Council Laboratories (Gambia)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Gambia
Outcome results
None listed