Rifaximin Fails to Prevent Campylobacteriosis in the Human Challenge Model: A Randomized, Double-Blind, Placebo-Controlled Trial

Joanna E. Rimmer, Clayton Harro, David Allen Sack, Kawsar Rasmy Talaat, Ramiro L. Gutierrez, Barbara DeNearing, Jessica Brubaker, Renee M. Laird, Frédéric Poly, Alexander C. Maue, Kayla Jaep, Ashley Alcala, Yelizaveta Mochalova, Christina L. Gariepy, Subhra Chakraborty, Patricia Guerry, David R. Tribble, Chad K. Porter, Mark S. Riddle

Research output: Contribution to journalArticle

Abstract

Background: Campylobacter species are a leading cause of diarrheal disease globally with significant morbidity. Primary prevention efforts have yielded limited results. Rifaximin chemoprophylaxis decreases rates of travelers' diarrhea and may be suitable for high-risk persons. We assessed the efficacy of rifaximin in the controlled human infection model for Campylobacter jejuni. Methods: Twenty-eight subjects were admitted to an inpatient facility and randomized to a twice-daily dose of 550 mg rifaximin or placebo. The following day, subjects ingested 1.7 × 105 colony-forming units of C. jejuni strain CG8421. Subjects continued prophylaxis for 3 additional days, were followed for campylobacteriosis for 144 hours, and were subsequently treated with azithromycin and ciprofloxacin. Samples were collected to assess immunologic responses to CG8421. Results: There was no difference (P = 1.0) in the frequency of campylobacteriosis in those receiving rifaximin (86.7%) or placebo (84.6%). Additionally, there were no differences in the clinical signs and symptoms of C. jejuni infection to include abdominal pain/cramps (P = 1.0), nausea (P = 1.0), vomiting (P = .2), or fever (P = 1.0) across study groups. Immune responses to the CG8421 strain were comparable across treatment groups. Conclusions: Rifaximin did not prevent campylobacteriosis in this controlled human infection model. Given the morbidity associated with Campylobacter infection, primary prevention efforts remain a significant need. Clinical Trials Registration: NCT02280044.

Original languageEnglish (US)
Pages (from-to)1435-1441
Number of pages7
JournalClinical infectious diseases : an official publication of the Infectious Diseases Society of America
Volume66
Issue number9
DOIs
StatePublished - Apr 17 2018

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rifaximin
Placebos
Campylobacter jejuni
Campylobacter Infections
Primary Prevention
Morbidity
Azithromycin
Campylobacter
Colic
Chemoprevention
Ciprofloxacin
Infection
Nausea
Abdominal Pain
Signs and Symptoms
Vomiting
Inpatients
Diarrhea
Fever
Stem Cells

ASJC Scopus subject areas

  • Microbiology (medical)
  • Infectious Diseases

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Rifaximin Fails to Prevent Campylobacteriosis in the Human Challenge Model : A Randomized, Double-Blind, Placebo-Controlled Trial. / Rimmer, Joanna E.; Harro, Clayton; Sack, David Allen; Talaat, Kawsar Rasmy; Gutierrez, Ramiro L.; DeNearing, Barbara; Brubaker, Jessica; Laird, Renee M.; Poly, Frédéric; Maue, Alexander C.; Jaep, Kayla; Alcala, Ashley; Mochalova, Yelizaveta; Gariepy, Christina L.; Chakraborty, Subhra; Guerry, Patricia; Tribble, David R.; Porter, Chad K.; Riddle, Mark S.

In: Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, Vol. 66, No. 9, 17.04.2018, p. 1435-1441.

Research output: Contribution to journalArticle

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 2018, 'Rifaximin Fails to Prevent Campylobacteriosis in the Human Challenge Model: A Randomized, Double-Blind, Placebo-Controlled Trial', Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, vol. 66, no. 9, pp. 1435-1441. https://doi.org/10.1093/cid/cix1014
Rimmer, Joanna E. ; Harro, Clayton ; Sack, David Allen ; Talaat, Kawsar Rasmy ; Gutierrez, Ramiro L. ; DeNearing, Barbara ; Brubaker, Jessica ; Laird, Renee M. ; Poly, Frédéric ; Maue, Alexander C. ; Jaep, Kayla ; Alcala, Ashley ; Mochalova, Yelizaveta ; Gariepy, Christina L. ; Chakraborty, Subhra ; Guerry, Patricia ; Tribble, David R. ; Porter, Chad K. ; Riddle, Mark S. / Rifaximin Fails to Prevent Campylobacteriosis in the Human Challenge Model : A Randomized, Double-Blind, Placebo-Controlled Trial. In: Clinical infectious diseases : an official publication of the Infectious Diseases Society of America. 2018 ; Vol. 66, No. 9. pp. 1435-1441.
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abstract = "Background: Campylobacter species are a leading cause of diarrheal disease globally with significant morbidity. Primary prevention efforts have yielded limited results. Rifaximin chemoprophylaxis decreases rates of travelers' diarrhea and may be suitable for high-risk persons. We assessed the efficacy of rifaximin in the controlled human infection model for Campylobacter jejuni. Methods: Twenty-eight subjects were admitted to an inpatient facility and randomized to a twice-daily dose of 550 mg rifaximin or placebo. The following day, subjects ingested 1.7 × 105 colony-forming units of C. jejuni strain CG8421. Subjects continued prophylaxis for 3 additional days, were followed for campylobacteriosis for 144 hours, and were subsequently treated with azithromycin and ciprofloxacin. Samples were collected to assess immunologic responses to CG8421. Results: There was no difference (P = 1.0) in the frequency of campylobacteriosis in those receiving rifaximin (86.7{\%}) or placebo (84.6{\%}). Additionally, there were no differences in the clinical signs and symptoms of C. jejuni infection to include abdominal pain/cramps (P = 1.0), nausea (P = 1.0), vomiting (P = .2), or fever (P = 1.0) across study groups. Immune responses to the CG8421 strain were comparable across treatment groups. Conclusions: Rifaximin did not prevent campylobacteriosis in this controlled human infection model. Given the morbidity associated with Campylobacter infection, primary prevention efforts remain a significant need. Clinical Trials Registration: NCT02280044.",
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T1 - Rifaximin Fails to Prevent Campylobacteriosis in the Human Challenge Model

T2 - A Randomized, Double-Blind, Placebo-Controlled Trial

AU - Rimmer, Joanna E.

AU - Harro, Clayton

AU - Sack, David Allen

AU - Talaat, Kawsar Rasmy

AU - Gutierrez, Ramiro L.

AU - DeNearing, Barbara

AU - Brubaker, Jessica

AU - Laird, Renee M.

AU - Poly, Frédéric

AU - Maue, Alexander C.

AU - Jaep, Kayla

AU - Alcala, Ashley

AU - Mochalova, Yelizaveta

AU - Gariepy, Christina L.

AU - Chakraborty, Subhra

AU - Guerry, Patricia

AU - Tribble, David R.

AU - Porter, Chad K.

AU - Riddle, Mark S.

PY - 2018/4/17

Y1 - 2018/4/17

N2 - Background: Campylobacter species are a leading cause of diarrheal disease globally with significant morbidity. Primary prevention efforts have yielded limited results. Rifaximin chemoprophylaxis decreases rates of travelers' diarrhea and may be suitable for high-risk persons. We assessed the efficacy of rifaximin in the controlled human infection model for Campylobacter jejuni. Methods: Twenty-eight subjects were admitted to an inpatient facility and randomized to a twice-daily dose of 550 mg rifaximin or placebo. The following day, subjects ingested 1.7 × 105 colony-forming units of C. jejuni strain CG8421. Subjects continued prophylaxis for 3 additional days, were followed for campylobacteriosis for 144 hours, and were subsequently treated with azithromycin and ciprofloxacin. Samples were collected to assess immunologic responses to CG8421. Results: There was no difference (P = 1.0) in the frequency of campylobacteriosis in those receiving rifaximin (86.7%) or placebo (84.6%). Additionally, there were no differences in the clinical signs and symptoms of C. jejuni infection to include abdominal pain/cramps (P = 1.0), nausea (P = 1.0), vomiting (P = .2), or fever (P = 1.0) across study groups. Immune responses to the CG8421 strain were comparable across treatment groups. Conclusions: Rifaximin did not prevent campylobacteriosis in this controlled human infection model. Given the morbidity associated with Campylobacter infection, primary prevention efforts remain a significant need. Clinical Trials Registration: NCT02280044.

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