Traveler's diarrhea in Thailand: Randomized, double-blind trial comparing single-dose and 3-day azithromycin-based regimens with a 3-day levofloxacin regimen

David R. Tribble, John W. Sanders, Lorrin W. Pang, Carl Mason, Chittima Pitarangsi, Shahida Baqar, Adam Armstrong, Paul Hshieh, Anne Fox, Elisabeth A. Maley, Carlos Lebron, Dennis J. Faix, James V. Lawler, Gautam Nayak, Michael Lewis, Ladaporn Bodhidatta, Daniel A. Scott

Research output: Contribution to journalArticle

121 Citations (Scopus)

Abstract

Background. Traveler's diarrhea in Thailand is frequently caused by Campylobacter jejuni. Rates of fluoroquinolone (FQ) resistance in Campylobacter organisms have exceeded 85% in recent years, and reduced fluoroquinolone efficacy has been observed. Methods. Azithromycin regimens were evaluated in a randomized, double-blind trial of azithromycin, given as a single 1-g dose or a 3-day regimen (500 mg daily), versus a 3-day regimen of levofloxacin (500 mg daily) in military field clinics in Thailand. Outcomes included clinical end points (time to the last unformed stool [TLUS] and cure rates) and microbiological end points (pathogen eradication). Results. A total of 156 patients with acute diarrhea were enrolled in the trial. Campylobacter organisms predominated (in 64% of patients), with levofloxacin resistance noted in 50% of Campylobacter organisms and with no azithromycin resistance noted. The cure rate at 72 h after treatment initiation was highest (96%) with single-dose azithromycin, compared with the cure rates of 85% noted with 3-day azithromycin and 71% noted with levofloxacin (P = .002). Single-dose azithromycin was also associated with the shortest median TLUS (35 h; P = .03, by log-rank test). Levofloxacin's efficacy was inferior to azithromycin's efficacy, except in patients with no pathogen identified during the first 24 h of treatment or in patients with levofloxacin-susceptible Campylobacter isolates, in whom it appeared to be equal to azithromycin. The rate of microbiological eradication was significantly better with azithromycin-based regimens (96%-100%), compared with levofloxacin (38%) (P = .001); however, this finding was poorly correlated with clinical outcome. A higher rate of posttreatment nausea in the 30 min after receipt of the first dose (14% vs. <6%; P = .06) was observed as a mild, self-limited complaint associated with single-dose azithromycin. Conclusions. Single-dose azithromycin is recommended for empirical therapy of traveler's diarrhea acquired in Thailand and is a reasonable first-line option for empirical management in general.

Original languageEnglish (US)
Pages (from-to)338-346
Number of pages9
JournalClinical Infectious Diseases
Volume44
Issue number3
DOIs
StatePublished - Feb 1 2007

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Levofloxacin
Azithromycin
Thailand
Diarrhea
Campylobacter
Fluoroquinolones
Campylobacter jejuni
Nausea
Therapeutics

ASJC Scopus subject areas

  • Microbiology (medical)
  • Infectious Diseases

Cite this

Traveler's diarrhea in Thailand : Randomized, double-blind trial comparing single-dose and 3-day azithromycin-based regimens with a 3-day levofloxacin regimen. / Tribble, David R.; Sanders, John W.; Pang, Lorrin W.; Mason, Carl; Pitarangsi, Chittima; Baqar, Shahida; Armstrong, Adam; Hshieh, Paul; Fox, Anne; Maley, Elisabeth A.; Lebron, Carlos; Faix, Dennis J.; Lawler, James V.; Nayak, Gautam; Lewis, Michael; Bodhidatta, Ladaporn; Scott, Daniel A.

In: Clinical Infectious Diseases, Vol. 44, No. 3, 01.02.2007, p. 338-346.

Research output: Contribution to journalArticle

Tribble, DR, Sanders, JW, Pang, LW, Mason, C, Pitarangsi, C, Baqar, S, Armstrong, A, Hshieh, P, Fox, A, Maley, EA, Lebron, C, Faix, DJ, Lawler, JV, Nayak, G, Lewis, M, Bodhidatta, L & Scott, DA 2007, 'Traveler's diarrhea in Thailand: Randomized, double-blind trial comparing single-dose and 3-day azithromycin-based regimens with a 3-day levofloxacin regimen', Clinical Infectious Diseases, vol. 44, no. 3, pp. 338-346. https://doi.org/10.1086/510589
Tribble, David R. ; Sanders, John W. ; Pang, Lorrin W. ; Mason, Carl ; Pitarangsi, Chittima ; Baqar, Shahida ; Armstrong, Adam ; Hshieh, Paul ; Fox, Anne ; Maley, Elisabeth A. ; Lebron, Carlos ; Faix, Dennis J. ; Lawler, James V. ; Nayak, Gautam ; Lewis, Michael ; Bodhidatta, Ladaporn ; Scott, Daniel A. / Traveler's diarrhea in Thailand : Randomized, double-blind trial comparing single-dose and 3-day azithromycin-based regimens with a 3-day levofloxacin regimen. In: Clinical Infectious Diseases. 2007 ; Vol. 44, No. 3. pp. 338-346.
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abstract = "Background. Traveler's diarrhea in Thailand is frequently caused by Campylobacter jejuni. Rates of fluoroquinolone (FQ) resistance in Campylobacter organisms have exceeded 85{\%} in recent years, and reduced fluoroquinolone efficacy has been observed. Methods. Azithromycin regimens were evaluated in a randomized, double-blind trial of azithromycin, given as a single 1-g dose or a 3-day regimen (500 mg daily), versus a 3-day regimen of levofloxacin (500 mg daily) in military field clinics in Thailand. Outcomes included clinical end points (time to the last unformed stool [TLUS] and cure rates) and microbiological end points (pathogen eradication). Results. A total of 156 patients with acute diarrhea were enrolled in the trial. Campylobacter organisms predominated (in 64{\%} of patients), with levofloxacin resistance noted in 50{\%} of Campylobacter organisms and with no azithromycin resistance noted. The cure rate at 72 h after treatment initiation was highest (96{\%}) with single-dose azithromycin, compared with the cure rates of 85{\%} noted with 3-day azithromycin and 71{\%} noted with levofloxacin (P = .002). Single-dose azithromycin was also associated with the shortest median TLUS (35 h; P = .03, by log-rank test). Levofloxacin's efficacy was inferior to azithromycin's efficacy, except in patients with no pathogen identified during the first 24 h of treatment or in patients with levofloxacin-susceptible Campylobacter isolates, in whom it appeared to be equal to azithromycin. The rate of microbiological eradication was significantly better with azithromycin-based regimens (96{\%}-100{\%}), compared with levofloxacin (38{\%}) (P = .001); however, this finding was poorly correlated with clinical outcome. A higher rate of posttreatment nausea in the 30 min after receipt of the first dose (14{\%} vs. <6{\%}; P = .06) was observed as a mild, self-limited complaint associated with single-dose azithromycin. Conclusions. Single-dose azithromycin is recommended for empirical therapy of traveler's diarrhea acquired in Thailand and is a reasonable first-line option for empirical management in general.",
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AU - Sanders, John W.

AU - Pang, Lorrin W.

AU - Mason, Carl

AU - Pitarangsi, Chittima

AU - Baqar, Shahida

AU - Armstrong, Adam

AU - Hshieh, Paul

AU - Fox, Anne

AU - Maley, Elisabeth A.

AU - Lebron, Carlos

AU - Faix, Dennis J.

AU - Lawler, James V.

AU - Nayak, Gautam

AU - Lewis, Michael

AU - Bodhidatta, Ladaporn

AU - Scott, Daniel A.

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N2 - Background. Traveler's diarrhea in Thailand is frequently caused by Campylobacter jejuni. Rates of fluoroquinolone (FQ) resistance in Campylobacter organisms have exceeded 85% in recent years, and reduced fluoroquinolone efficacy has been observed. Methods. Azithromycin regimens were evaluated in a randomized, double-blind trial of azithromycin, given as a single 1-g dose or a 3-day regimen (500 mg daily), versus a 3-day regimen of levofloxacin (500 mg daily) in military field clinics in Thailand. Outcomes included clinical end points (time to the last unformed stool [TLUS] and cure rates) and microbiological end points (pathogen eradication). Results. A total of 156 patients with acute diarrhea were enrolled in the trial. Campylobacter organisms predominated (in 64% of patients), with levofloxacin resistance noted in 50% of Campylobacter organisms and with no azithromycin resistance noted. The cure rate at 72 h after treatment initiation was highest (96%) with single-dose azithromycin, compared with the cure rates of 85% noted with 3-day azithromycin and 71% noted with levofloxacin (P = .002). Single-dose azithromycin was also associated with the shortest median TLUS (35 h; P = .03, by log-rank test). Levofloxacin's efficacy was inferior to azithromycin's efficacy, except in patients with no pathogen identified during the first 24 h of treatment or in patients with levofloxacin-susceptible Campylobacter isolates, in whom it appeared to be equal to azithromycin. The rate of microbiological eradication was significantly better with azithromycin-based regimens (96%-100%), compared with levofloxacin (38%) (P = .001); however, this finding was poorly correlated with clinical outcome. A higher rate of posttreatment nausea in the 30 min after receipt of the first dose (14% vs. <6%; P = .06) was observed as a mild, self-limited complaint associated with single-dose azithromycin. Conclusions. Single-dose azithromycin is recommended for empirical therapy of traveler's diarrhea acquired in Thailand and is a reasonable first-line option for empirical management in general.

AB - Background. Traveler's diarrhea in Thailand is frequently caused by Campylobacter jejuni. Rates of fluoroquinolone (FQ) resistance in Campylobacter organisms have exceeded 85% in recent years, and reduced fluoroquinolone efficacy has been observed. Methods. Azithromycin regimens were evaluated in a randomized, double-blind trial of azithromycin, given as a single 1-g dose or a 3-day regimen (500 mg daily), versus a 3-day regimen of levofloxacin (500 mg daily) in military field clinics in Thailand. Outcomes included clinical end points (time to the last unformed stool [TLUS] and cure rates) and microbiological end points (pathogen eradication). Results. A total of 156 patients with acute diarrhea were enrolled in the trial. Campylobacter organisms predominated (in 64% of patients), with levofloxacin resistance noted in 50% of Campylobacter organisms and with no azithromycin resistance noted. The cure rate at 72 h after treatment initiation was highest (96%) with single-dose azithromycin, compared with the cure rates of 85% noted with 3-day azithromycin and 71% noted with levofloxacin (P = .002). Single-dose azithromycin was also associated with the shortest median TLUS (35 h; P = .03, by log-rank test). Levofloxacin's efficacy was inferior to azithromycin's efficacy, except in patients with no pathogen identified during the first 24 h of treatment or in patients with levofloxacin-susceptible Campylobacter isolates, in whom it appeared to be equal to azithromycin. The rate of microbiological eradication was significantly better with azithromycin-based regimens (96%-100%), compared with levofloxacin (38%) (P = .001); however, this finding was poorly correlated with clinical outcome. A higher rate of posttreatment nausea in the 30 min after receipt of the first dose (14% vs. <6%; P = .06) was observed as a mild, self-limited complaint associated with single-dose azithromycin. Conclusions. Single-dose azithromycin is recommended for empirical therapy of traveler's diarrhea acquired in Thailand and is a reasonable first-line option for empirical management in general.

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