Efficacy of Rifaximin in Preventing Campylobacteriosis

Summary

This study is a randomized, double-blinded, placebo-controlled, in-patient trial evaluating the prophylactic efficacy of rifaximin against campylobacteriosis following challenge with C. jejuni.

Timeline

Start

2014-10

Primary completion

2016-08-09

Completion

2016-08-09

Outcome

Missed primary endpoint

paper There was no difference (P = 1.0) in the frequency of campylobacteriosis in those receiving rifaximin (86.7%) or placebo (84.6%). PMID 29145631 ↗

Publications

• Results Kirkpatrick BD, Lyon CE, Porter CK, Maue AC, Guerry P, Pierce KK, Carmolli MP, Riddle MS, Larsson CJ, Hawk D, Dill EA, Fingar A, Poly F, Fimlaid KA, Hoq F, Tribble DR. Lack of homologous protection against Campylobacter jejuni CG8421 in a human challenge model. Clin Infect Dis. 2013 Oct;57(8):1106-13. doi: 10.1093/cid/cit454. Epub 2013 Jul 9.
• Results Riddle MS, Gutierrez RL, Verdu EF, Porter CK. The chronic gastrointestinal consequences associated with campylobacter. Curr Gastroenterol Rep. 2012 Oct;14(5):395-405. doi: 10.1007/s11894-012-0278-0.
• Results Tribble DR, Baqar S, Scott DA, Oplinger ML, Trespalacios F, Rollins D, Walker RI, Clements JD, Walz S, Gibbs P, Burg EF 3rd, Moran AP, Applebee L, Bourgeois AL. Assessment of the duration of protection in Campylobacter jejuni experimental infection in humans. Infect Immun. 2010 Apr;78(4):1750-9. doi: 10.1128/IAI.01021-09. Epub 2010 Jan 19.
• Results Tribble DR, Baqar S, Carmolli MP, Porter C, Pierce KK, Sadigh K, Guerry P, Larsson CJ, Rockabrand D, Ventone CH, Poly F, Lyon CE, Dakdouk S, Fingar A, Gilliland T, Daunais P, Jones E, Rymarchyk S, Huston C, Darsley M, Kirkpatrick BD. Campylobacter jejuni strain CG8421: a refined model for the study of Campylobacteriosis and evaluation of Campylobacter vaccines in human subjects. Clin Infect Dis. 2009 Nov 15;49(10):1512-9. doi: 10.1086/644622.
• Results Poly F, Read TD, Chen YH, Monteiro MA, Serichantalergs O, Pootong P, Bodhidatta L, Mason CJ, Rockabrand D, Baqar S, Porter CK, Tribble D, Darsley M, Guerry P. Characterization of two Campylobacter jejuni strains for use in volunteer experimental-infection studies. Infect Immun. 2008 Dec;76(12):5655-67. doi: 10.1128/IAI.00780-08. Epub 2008 Sep 22.
• Results Flores J, Dupont HL, Jiang ZD, Okhuysen PC, Melendez-Romero JH, Gonzalez-Estrada A, Carrillo I, Paredes M. A randomized, double-blind, pilot study of rifaximin 550 mg versus placebo in the prevention of travelers' diarrhea in Mexico during the dry season. J Travel Med. 2011 Sep-Oct;18(5):333-6. doi: 10.1111/j.1708-8305.2011.00549.x. Epub 2011 Aug 1.
• Results Martinez-Sandoval F, Ericsson CD, Jiang ZD, Okhuysen PC, Romero JH, Hernandez N, Forbes WP, Shaw A, Bortey E, DuPont HL. Prevention of travelers' diarrhea with rifaximin in US travelers to Mexico. J Travel Med. 2010 Mar-Apr;17(2):111-7. doi: 10.1111/j.1708-8305.2009.00385.x.
• Results Steffen R, Sack DA, Riopel L, Jiang ZD, Sturchler M, Ericsson CD, Lowe B, Waiyaki P, White M, DuPont HL. Therapy of travelers' diarrhea with rifaximin on various continents. Am J Gastroenterol. 2003 May;98(5):1073-8. doi: 10.1111/j.1572-0241.2003.07283.x.
• Results Infante RM, Ericsson CD, Jiang ZD, Ke S, Steffen R, Riopel L, Sack DA, DuPont HL. Enteroaggregative Escherichia coli diarrhea in travelers: response to rifaximin therapy. Clin Gastroenterol Hepatol. 2004 Feb;2(2):135-8. doi: 10.1016/s1542-3565(03)00322-7.
• Results Armstrong AW, Ulukan S, Weiner M, Mostafa M, Shaheen H, Nakhla I, Tribble DR, Riddle MS. A randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of rifaximin for the prevention of travelers' diarrhea in US military personnel deployed to Incirlik Air Base, Incirlik, Turkey. J Travel Med. 2010 Nov-Dec;17(6):392-4. doi: 10.1111/j.1708-8305.2010.00462.x.
• Results Dupont HL, Jiang ZD, Belkind-Gerson J, Okhuysen PC, Ericsson CD, Ke S, Huang DB, Dupont MW, Adachi JA, De La Cabada FJ, Taylor DN, Jaini S, Martinez Sandoval F. Treatment of travelers' diarrhea: randomized trial comparing rifaximin, rifaximin plus loperamide, and loperamide alone. Clin Gastroenterol Hepatol. 2007 Apr;5(4):451-6. doi: 10.1016/j.cgh.2007.02.004. Epub 2007 Mar 26.
• Results DuPont HL, Jiang ZD, Ericsson CD, Adachi JA, Mathewson JJ, DuPont MW, Palazzini E, Riopel LM, Ashley D, Martinez-Sandoval F. Rifaximin versus ciprofloxacin for the treatment of traveler's diarrhea: a randomized, double-blind clinical trial. Clin Infect Dis. 2001 Dec 1;33(11):1807-15. doi: 10.1086/323814. Epub 2001 Oct 23.
• Rimmer JE, Harro C, Sack DA, Talaat KR, Gutierrez RL, DeNearing B, Brubaker J, Laird RM, Poly F, Maue AC, Jaep K, Alcala A, Mochalova Y, Gariepy CL, Chakraborty S, Guerry P, Tribble DR, Porter CK, Riddle MS. Rifaximin Fails to Prevent Campylobacteriosis in the Human Challenge Model: A Randomized, Double-Blind, Placebo-Controlled Trial. Clin Infect Dis. 2018 Apr 17;66(9):1435-1441. doi: 10.1093/cid/cix1014.

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