OBJECTIVE: To assess the efficacy and occurrence of severe side effect
s associated with the use of a single dose of azithromycin in the trea
tment of Chlamydia trachomatis in pregnant women. STUDY DESIGN: Patien
ts and their sexual partners were randomized into three treatment grou
ps: both the patient and her sexual partner received a single dose of
azithromycin (group 1); the patient was given a standard course of ery
thromycin, while her partner was given a standard course of tetracycli
ne (group 2); and the patient was given a single dose of azithromycin
with the sexual partner given a standard course of tetracycline (group
3). Group 3 was included in order to assess the relative efficacy of
tetracycline with re spect to the use of azithromycin among patients a
nd to indirectly assess possible patient reinfection by sexual partner
s. RESULTS: With respect to the cure rate, 4.5% of study participants
given azithromycin has positive cultures vs. 21.1% of patients given e
rythromycin or tetracycline (P = .018). With respect to side effects s
evere enough to warrant a change in medication, 7.4% of patients recei
ving azithromycin reported suffering such side effects vs. 38.8% of pa
tients given erythromycin (P = .02). Among sexual partners, 28.6% give
n tetracycline reported severe side effects vs. none of those given az
ithromycin (P = .03). CONCLUSION: Azithromycin in the treatment of C t
rachomatis in pregnant women substantially improved the cure rates whi
le substantially reducing the occurrence of severe side effects associ
ated with the use of a standard course of erythromycin. Since both tet
racycline and erythromycin are known to be effective against C trachom
atis infection, the improved efficacy of azithromycin is probably due
to noncompliance with the multidose, multiday regimen associated with
the use of these two antibiotics.