Effectiveness of discontinuing antibiotic treatment after three days versus eight days in mild to moderate-severe community acquired pneumonia: randomised, double blind study

doi:10.1136/bmj.332.7554.1355

BMJ 2006;332:1355 (10 June), doi:10.1136/bmj.332.7554.1355

Research

Effectiveness of discontinuing antibiotic treatment after three days versus eight days in mild to moderate-severe community acquired pneumonia: randomised, double blind study

Rachida el Moussaoui, clinical research fellow¹, Corianne A J M de Borgie, clinical epidemiologist², Peterhans van den Broek, professor of infectious diseases³, Willem N Hustinx, internist in infectious diseases⁴, Paul Bresser, pulmonologist⁵, Guido E L van den Berk, resident⁶, Jan-Werner Poley, resident⁷, Bob van den Berg, pulmonologist⁸, Frans H Krouwels, pulmonologist⁹, Marc J M Bonten, professor of infectious diseases¹⁰, Carla Weenink, pulmonologist¹¹, Patrick M M Bossuyt, professor of clinical epidemiology², Peter Speelman, professor of infectious diseases¹, Brent C Opmeer, clinical epidemiologist², Jan M Prins, internist in infectious diseases¹

¹ Department of Internal Medicine, Division of Infectious Diseases, Tropical Medicine and AIDS, Academic Medical Center, Meibergdreef 9, 1105 AZ Amsterdam, Netherlands, ² Department of Clinical Epidemiology and Biostatistics, Academic Medical Center, Amsterdam, ³ Department of Internal Medicine, Leiden University Medical Center, Leiden, Netherlands, ⁴ Department of Internal Medicine, Diaconessenhuis, Utrecht, Netherlands, ⁵ Department of Pulmonology, Academic Medical Center, Amsterdam, ⁶ Department of Internal Medicine, Onze Lieve Vrouwe Gasthuis, Amsterdam, ⁷ Department of Internal Medicine, Sint Lucas-Andreas Hospital, Amsterdam, ⁸ Department of Pulmonology, Sint Lucas-Andreas Hospital, ⁹ Department of Pulmonology, Onze Lieve Vrouwe Gasthuis, ¹⁰ Department of Internal Medicine, University Medical Center Utrecht, ¹¹ Department of Pulmonology, Kennemer Gasthuis, Haarlem, Netherlands

Correspondence to: J M Prins j.m.prins{at}amc.uva.nl

Abstract

Objective To compare the effectiveness of discontinuing treatmentwith amoxicillin after three days or eight days in adults admittedto hospital with mild to moderate-severe community acquiredpneumonia who substantially improved after an initial threedays' treatment.

Design Randomised, double blind, placebo controlled non-inferioritytrial.

Setting Nine secondary and tertiary care hospitals in the Netherlands.

Participants Adults with mild to moderate-severe community acquiredpneumonia (pneumonia severity index score $≤$ 110).

Interventions Patients who had substantially improved afterthree days' treatment with intravenous amoxicillin were randomlyassigned to oral amoxicillin (n = 63) or placebo (n = 56) threetimes daily for five days.

Main outcome measures The primary outcome measure was the clinicalsuccess rate at day 10. Secondary outcome measures were theclinical success rate at day 28, symptom resolution, radiologicalsuccess rates at days 10 and 28, and adverse events.

Results Baseline characteristics were comparable, with the exceptionof symptom severity, which was worse in the three day treatmentgroup. In the three day and eight day treatment groups the clinicalsuccess rate at day 10 was 93% for both (difference 0.1%, 95%confidence interval - 9% to 10%) and at day 28 was 90% comparedwith 88% (difference 2.0%, - 9% to 15%). Both groups had similarresolution of symptoms. Radiological success rates were 86%compared with 83% at day 10 (difference 3%, - 10% to 16%) and86% compared with 79% at day 28 (difference 6%, - 7% to 20%).Six patients (11%) in the placebo group and 13 patients (21%)in the active treatment group reported adverse events (P = 0.1).

Conclusions Discontinuing amoxicillin treatment after threedays is not inferior to discontinuing it after eight days inadults admitted to hospital with mild to moderate-severe communityacquired pneumonia who substantially improved after an initialthree days' treatment.

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