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

Completed

Conditions: Community acquired pneumonia in children
Respiratory

Registration Number: ISRCTN85118989

Lead Sponsor: Medical Research Council Laboratories (Gambia)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 905

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Treatment failure: <br>1.1. 3 days after enrolment there was no improvement<br>or<br>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. <br>All children were assessed by nurses on days 3 and 5 post-enrolment. Treatment failures were confirmed by study pediatricians.

Secondary Outcome Measures

Name	Time	Method
1. Relapse: <br>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. <br>2. Compliance: <br>Proportion of children given full prescribed dosage (this was assessed by measuring left-over trial antimicrobials in the bottles on days 3 and 5). <br>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.