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 language | English (US) |
|---|---|
| Pages (from-to) | 1435-1441 |
| Number of pages | 7 |
| Journal | Clinical infectious diseases : an official publication of the Infectious Diseases Society of America |
| Volume | 66 |
| Issue number | 9 |
| DOIs | |
| State | Published - Apr 17 2018 |
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ASJC Scopus subject areas
- Microbiology (medical)
- Infectious Diseases
Cite this
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 journal › Article
}
TY - JOUR
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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85068764184&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85068764184&partnerID=8YFLogxK
U2 - 10.1093/cid/cix1014
DO - 10.1093/cid/cix1014
M3 - Article
C2 - 29145631
AN - SCOPUS:85068764184
VL - 66
SP - 1435
EP - 1441
JO - Clinical Infectious Diseases
JF - Clinical Infectious Diseases
SN - 1058-4838
IS - 9
ER -