Oral co-amoxiclav was as effective as intravenous antibiotics for community-acquired lower respiratory tract infection
ACP J Club. 1995 Nov-Dec;123:65. doi:10.7326/ACPJC-1995-123-3-065
Chan R, Hemeryck L, O'Regan M, Clancy L, Feely J. Oral versus intravenous antibiotics for community acquired lower respiratory tract infection in a general hospital: open, randomised controlled trial. BMJ. 1995 May 27;310:1360-2.
To compare the effectiveness of oral co-amoxiclav with intravenous (IV) co-amoxiclav and with IV cefotaxime in patients with community-acquired lower respiratory tract infection (LRTI).
Randomized controlled trial.
Hospital in Ireland.
541 patients (mean age 64 y, 52% women) who were > 14 years of age and had a clinical diagnosis of community-acquired LRTI defined by a sputum-producing cough and associated symptoms or signs of chest infection and by the presence of ≥ 1 of the following: fever, sweating, headache, or aches and pains. Exclusion criteria were immunocompromised status, allergy to penicillin or cephalosporins, critical illness requiring intensive care or inotropic or respiratory support, septicemia, inability to take oral medicines, acute confusion, multilobar disease, and pregnancy or lactation.
Patients were allocated to oral co-amoxiclav, 375 mg 3 times/d for 7 days (n = 181), IV co-amoxiclav, 1.2 g 3 times/d for 3 days, then 375 mg orally 3 times/d for 4 days (n = 181), or IV cefotaxime, 1 g 3 times/d for 3 days, then oral cefuroxime axetil, 500 mg 2 times/d (n = 179).
Main outcome measures
Cure (total resolution of symptoms or signs), partial cure (resolution of some symptoms or signs and fit for discharge), extension of antibiotic duration, change in antibiotic, mortality, and duration of hospital stay.
The groups did not differ for cure, partial cure, antibiotic extension or change, or mortality. The patients receiving oral co-amoxiclav had a shorter hospital stay than the patients in the other 2 groups (P < 0.05). More patients who received oral co-amoxiclav were discharged within 3 days compared with those who received IV co-amaxiclav or IV cefotaxime (Table).
Oral co-amoxiclav was as effective as intravenous co-amoxiclav and intravenous cefotaxime and resulted in shorter hospital stays in patients with community-acquired lower respiratory tract infection.
Source of funding: Health Research Board.
For article reprint: Professor J. Feely, Department of Pharmacology and Therapeutics, Trinity Centre for Health Sciences, St. James's Hospital, Dublin 8, Ireland. FAX 353-1-671-3507.
Table. Oral co-amoxiclav vs intravenous (IV) co-amoxiclav and vs IV cefotaxime in patients with community-acquired lower respiratory tract infection*
|Outcome||Oral co-amoxiclav||IV co-amoxiclav||IV cefotaxine||RRR (95% CI)||NNT (CI)|
|Discharge within 3 d||20%||6%||227% (75 to 519)||8 (5 to 14)|
|20%||6%||256% (86 to 591)||7 (5 to 13)|
*Abbreviations defined in Glossary; RRR, NNT, and CI calculated from data in article.
Three key questions emerge from a review of the study by Chan and colleagues. First, how many of the patients could have been treated at home? Second, should pneumonia be distinguished from bronchitis? Third, is it safe to ignore Legionella species, Mycoplasma pneumoniae, and Chlamydia pneumoniae in recommending an antimicrobial agent for the treatment of LRTI?
Substantial regional variation exists in the hospitalization rates for community-acquired pneumonia (CAP) (1). This observation and the results of the study by Chan and colleagues indicate that what we really need are criteria to identify patients who can be safely treated at home. Numerous studies have validated the risk factors for a complicated course or death in patients with CAP (2). It is axiomatic (but perhaps needs verification) that oral antibiotic therapy at home is better than oral antibiotic therapy in the hospital when that is all that is necessary for the treatment of LRTI.
Pneumonia and bronchitis have different etiologies and prognoses, and subgroups exist even within these 2 entities. Both Canadian and American guidelines for the empiric antibiotic therapy for these conditions base decisions on age, severity of illness, and location of therapy (home or hospital) for pneumonia (3) and for bronchitis (4). Interestingly, the British Thoracic Society guidelines (5) differ considerably. None of these guidelines, however, has been evaluated.
Studies of CAP requiring hospitalization indicate that Legionella species, M. pneumoniae, Chlamydia species , Coxiella burnetti, and respiratory tract viruses caused 31% of the cases of pneumonia. These agents do not respond to treatment with a β-lactam antibiotic.
We should separate LRTI into pneumonia and bronchitis; patients with CAP should be treated at home with oral antibiotics unless severity of illness or extenuating circumstances dictate admission to hospital. Finally, it is clear that small trials and the ruminations of experts are no longer sufficient and that multicenter trials are needed to determine the antibiotics of choice.
Tom Marrie, MD
Dalhousie UniversityHalifax, Nova Scotia, Canada
3. Niederman MS, Bass JB Jr, Campbell GD, et al. Guidelines for the initial management of adults with community-acquired pneumonia: diagnosis, assessment of severity, and initial antimicrobial therapy. American Thoracic Society. Medical Section of the American Lung Association. Am Rev Respir Dis. 1993;148:1418-26.