Editor—Some aspects of the clinical trial of the ISCAP Study Group on non-severe pneumonia in young children deserve comment.1
Evidence of pneumonia on chest radiography was not an inclusion criterion. In general practice, chest radiography can be considered a pragmatic reference standard for pneumonia.2 In fact, the study was performed in patients with clinical suspicion of pneumonia but not in patients with pneumonia. The response criteria were not criteria of clinical cure but of impairment. Patients not impaired at three or five days cannot be considered cured. Moreover, the standard duration of treatment with amoxicillin in children with pneumonia is not five days but seven to 10 days.3 Thus we consider that the three day treatment arm was not compared with standard treatment.
In the section about adverse reactions the authors mention that there were no serious adverse effects of amoxicillin but there were 41 admissions to hospital. We have to consider that any admission was due to an adverse effect of amoxicillin because an adverse effect that leads to hospital admission must be considered serious.4
Competing interests: None declared.
References
- 1.ISCAP Study Group. Three day versus five day treatment with amoxicillin for non-severe pneumonia in young children: a multicentre randomised controlled trial. BMJ 2004;328: 791-7. (3 April.) [DOI] [PMC free article] [PubMed] [Google Scholar]
- 2.Margolis P, Gadomski A. Does this infant have pneumonia? JAMA 1998;279: 308-13. [DOI] [PubMed] [Google Scholar]
- 3.British Thoracic Society Standards of Care Committee. British Thoracic Society guidelines for the management of community acquired pneumonia in childhood. Thorax 2002;57(suppl 1): 1-24. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 4.Council for International Organisations of Medical Sciences. Current challenges in pharmacovigilance: pragmatic approaches: report of CIOMS working group V. Geneva: CIOMS, 2001.