Diarrhea Clinical Trial
Official title:
Loperamide Plus Azithromycin More Effectively Treats Travelers' Diarrhea In Mexico Than Azithromycin Alone
In a previous study azithromycin proved as efficacious as levofloxacin in the treatment of
travelers' diarrhea in Mexico. Because the addition of loperamide to some antibiotics (e.g.,
trimethoprim-sulfamethoxazole and ofloxacin) has proven more efficacious than antibiotic
alone in the treatment of travelers' diarrhea, we decided to study the addition of
loperamide to azithromycin.
US adults with acute diarrhea in Guadalajara Mexico were randomized to receive azithromycin
in two different doses or loperamide plus azithromycin.
The duration of diarrhea was shorter (11 hours) in the combination-treated group compared to
the antibiotic-treated groups (34 hours). The percentage of subjects continuing to pass 6 or
more unformed stools in the first 24 hours was less (1.7%) in the combination-treated group
than in the antibiotic-treated groups (20%).
We feel loperamide should routinely be added to an antibiotic to optimize treatment of
travelers' diarrhea.
Background. The combination of loperamide and trimethoprim-sulfamethoxazole or a
fluoroquinolone has proven to be more efficacious than the antimicrobial agent alone in the
treatment of travelers' diarrhea. We set out to prove loperamide plus azithromycin was more
efficacious that azithromycin alone.
Methods. During the summers of 2002-3, 176 US adults recently arrived in Guadalajara, Mexico
were enrolled in a prospective, double-blinded, randomized trial of the treatment of acute
diarrhea. Subjects received single doses (1000 mg or 500 mg) of azithromycin or a single 500
mg dose of azithromycin plus loperamide. Subjects gave a pre and post treatment stool sample
for analysis and maintained daily diaries of symptoms and passage of stools.
Results. The MIC90 of azithromycin for all E. coli and Shigella was 0.03 and 4 µg/ml with
eradication rates in day 5 stools of 88% and 100%, respectively. The duration of diarrhea
was significantly (p=0.0002) shorter following treatment with azithromycin plus loperamide
(11 h) than with either dose of azithromycin alone (34 h). In the first 24 h the average
number of unformed stools passed was 3.4 (azithromycin-alone) and 1.2 (combination) for a
significant (p<0.0001) difference of 2.2 unformed stools. This difference equated with 20%
of azithromycin-treated subjects continuing to pass 6 or more unformed stools in the first
24 h post treatment compared with only 1.7% of combination-treated subjects.
Conclusions. For the treatment of travelers' diarrhea in an E. coli predominant region of
the world a single 500 mg dose of azithromycin appeared as effective as a 1000 mg dose.
Loperamide plus 500 mg azithromycin was safe and more effective than either dose of
azithromycin. To realize the substantial clinical benefit that accrues to a subset of
subjects, we feel loperamide should routinely be used in combination with an antimicrobial
agent to treat travelers' diarrhea.
;
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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