Clinical trial: randomised placebo-controlled study of clarithromycin in active Crohn’s disease

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http://www.blackwell-synergy.com/doi/abs/10.1111/j.1365-2036.2008.03661.x

Alimentary Pharmacology & Therapeutics

OnlineAccepted Articles (Accepted, unedited articles or abstracts published online for future issues)

To cite this article: K. LEIPER, K. MARTIN, A. ELLIS, A. J. M. WATSON, A. I. MORRIS, J. M. RHODES (2008) Clinical trial: randomised placebo-controlled study of clarithromycin in active Crohn’s disease doi:10.1111/j.1365-2036.2008.03661.x (Online Accepted)

Clinical trial: randomised placebo-controlled study of clarithromycin in active Crohn’s disease

K. LEIPER, K. MARTIN, A. ELLIS, A. J. M. WATSON**School of Clinical Science, University of Liverpool, L69 3GA, UK, A. I. MORRIS & J. M. RHODES**School of Clinical Science, University of Liverpool, L69 3GA, UK

Department of Gastroenterology, Royal Liverpool and Broadgreen University Hospitals, Prescot Street, Liverpool, L7 8XP, *School of Clinical Science, University of Liverpool, L69 3GA, UK

Corresponding author Dr Leiper, Link 5Z, Department of Gastroenterology, Royal Liverpool and Broadgreen University Hospitals, Prescot Street, Liverpool, L7 8XPemail keith.leiper@...

Trial number NCT00269386 ClinicalTrials.com.CD, Crohn’s disease; CDAI, Crohn’s disease activity index; HBI, Harvey Bradshaw index

Abstract

Backgound: Crohn’s disease (CD) is characterised by defective innate immune responses to intestinal bacteria. Clarithromycin is a broad-spectrum antibiotic that has good penetration into macrophages.

Aim: To assess the efficacy of clarithromycin in active CD.

Methods. Patients with Crohn’s disease activity index (CDAI) >200 and serum CRP ≥10mg/l were randomised to receive clarithromycin 1g o.d. or placebo for 3 months. Patients taking more than 10mg/day prednisolone or 3mg/day budesonide were excluded. Primary outcome was remission (CDAI≤ 150) or response (fall in CDAI ≥ 70 from pretreatment level) at 3 months.

Results: The trial was stopped after 41 patients had been randomised because of poor overall efficacy. There was no difference in combined remission or response rates at 3 months between clarithromycin: 26% (5/19) and placebo: 27% (6/22), (p=1.00). The mean (SD) fall in CDAI was 35 (80) clarithromycin and –2 (114) placebo (p=0.24). However, post-hoc analysis showed a significant difference in response/remission determined by CDAI after one month: 53% (10/19) clarithromycin versus 14% (3/22) placebo (p=0.01).

Conclusion: Clarithromycin 1g for three months is ineffective in active CD but possible benefit was observed at one month, suggesting that an initial effect may be attenuated by subsequent bacterial resistance.