Amoxicillin for acute lower-respiratory-tract infection in primary care when pneumonia is not suspected: a 12-country, randomised, placebo-controlled trial

Background: Lower-respiratory-tract infection is one of the most common acute illnesses managed in primary care. Few placebo-controlled studies of antibiotics have been done, and overall effectiveness (particularly in subgroups such as older people) is debated. We aimed to compare the benefits and harms of amoxicillin for acute lower-respiratory-tract infection with those of placebo both overall and in patients aged 60 years or older.Methods: Patients older than 18 years with acute lower-respiratory-tract infections (cough of ?28 days' duration) in whom pneumonia was not suspected were randoml... Mehr ...

Verfasser: Paul Little
Sigvard Mölstad
Sławomir Chlabicz
Helena Hupkova
Antoni Torres
Christopher C Butler
Maciek Godycki-Cwirko
An De Sutter
Mel Davies
Janko Kersnik
Curt Brugman
Jordi Almirall
Mark Mullee
Pia Touboul
Gilly O'Reilly
Theo J M Verheij
Francesco Blasi
Michael Moore
Tom Schaberg
Herman Goossens
Beth Stuart
Artur Mierzecki
Kerenza Hood
Samuel Coenen
Dokumenttyp: Artikel
Erscheinungsdatum: 2013
Schlagwörter: Netherlands / Infectious Diseases
Sprache: Englisch
Permalink: https://search.fid-benelux.de/Record/base-27200786
Datenquelle: BASE; Originalkatalog
Powered By: BASE
Link(s) : https://www.openaccessrepository.it/record/90247

Background: Lower-respiratory-tract infection is one of the most common acute illnesses managed in primary care. Few placebo-controlled studies of antibiotics have been done, and overall effectiveness (particularly in subgroups such as older people) is debated. We aimed to compare the benefits and harms of amoxicillin for acute lower-respiratory-tract infection with those of placebo both overall and in patients aged 60 years or older.Methods: Patients older than 18 years with acute lower-respiratory-tract infections (cough of ?28 days' duration) in whom pneumonia was not suspected were randomly assigned (1:1) to either amoxicillin (1 g three times daily for 7 days) or placebo by computer-generated random numbers. Our primary outcome was duration of symptoms rated "moderately bad" or worse. Secondary outcomes were symptom severity in days 2—4 and new or worsening symptoms. Investigators and patients were masked to treatment allocation. This trial is registered with EudraCT (2007-001586-15), UKCRN Portfolio (ID 4175), ISRCTN (52261229), and FWO (G.0274.08N).Findings: 1038 patients were assigned to the amoxicillin group and 1023 to the placebo group. Neither duration of symptoms rated "moderately bad" or worse (hazard ratio 1·06, 95% CI 0·96—1·18; p=0·229) nor mean symptom severity (1·69 with placebo vs 1·62 with amoxicillin; difference ?0·07 [95% CI ?0·15 to 0·007]; p=0·074) differed significantly between groups. New or worsening symptoms were significantly less common in the amoxicillin group than in the placebo group (162 [15·9%] of 1021 patients vs 194 [19·3%] of 1006; p=0·043; number needed to treat 30). Cases of nausea, rash, or diarrhoea were significantly more common in the amoxicillin group than in the placebo group (number needed to harm 21, 95% CI 11—174; p=0·025), and one case of anaphylaxis was noted with amoxicillin. Two patients in the placebo group and one in the amoxicillin group needed to be admitted to hospital; no study-related deaths were noted. We noted no evidence of selective benefit in ...