Randomized comparison of ampicillin-sulbactam to cefoxitin and doxycycline or clindamycin and gentamicin in the treatment of pelvic inflammatory disease or endometritis.
OBJECTIVE
To evaluate the efficacy and safety of ampicillin-sulbactam (3 g every 6 hours) in patients with pelvic inflammatory disease or postpartum endometritis using a randomized, comparative, multicenter study of parallel design.


METHODS
Eligible patients with pelvic inflammatory disease were randomized to receive either ampicillin-sulbactam or cefoxitin (2 g every 6 hours) plus doxycycline (100 mg every 12 hours). Those with endometritis were randomized to ampicillin-sulbactam or clindamycin (900 mg every 8 hours) plus gentamicin (1.5 mg/kg every 8 hours). In the ampicillin-sulbactam group, chlamydia-positive patients also received oral doxycycline.


RESULTS
For pelvic inflammatory disease, the clinical response rates (cure or improvement) were 85.5% (47 of 55) and 89.6% (43 of 48) in the ampicillin-sulbactam and cefoxitin and doxycycline groups, respectively (chi 2 = 0.10, P = .76). For endometritis, the clinical response rates were 88.7% (141 of 159) and 90.8% (139 of 153) in the ampicillin-sulbactam and clindamycin and gentamicin groups, respectively (chi 2 = 0.15, P = .70). The percentages of patients with pelvic inflammatory disease who had adverse experiences were not significantly different in the cefoxitin and doxycycline group (47% [29 of 62]) than in those receiving ampicillin-sulbactam (33% [22 of 66]) (P = .12). These adverse effects were mostly mild or moderate. In the endometritis subjects, the incidence of adverse experiences in the ampicillin-sulbactam group (11% [20 of 179]) was comparable to that during treatment with clindamycin and gentamicin (12% [22 of 180]). These adverse experiences were also mostly mild to moderate.


CONCLUSIONS
Ampicillin-sulbactam is as effective and well tolerated as combination regimens using cefoxitin plus doxycycline and clindamycin plus-gentamicin for the treatment of pelvic inflammatory disease or endometritis, respectively.
McGregor
J A
JA
Department of Obstetrics and Gynecology, University of Colorado, Denver.
Crombleholme
W R
WR
Newton
E
E
Sweet
R L
RL
Tuomala
R
R
Gibbs
R S
RS
D000328:Adult; D000667:Ampicillin / Q000009:adverse effects / Q000627:therapeutic use; D002440:Cefoxitin / Q000009:adverse effects / Q000627:therapeutic use; D002981:Clindamycin / Q000009:adverse effects / Q000627:therapeutic use; D004318:Doxycycline / Q000009:adverse effects / Q000627:therapeutic use; D004359:Drug Therapy, Combination / Q000627:therapeutic use*; D004716:Endometritis / Q000188:drug therapy*; D005260:Female; D005839:Gentamicins / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D000292:Pelvic Inflammatory Disease / Q000188:drug therapy*; D011645:Puerperal Infection / Q000188:drug therapy; D013407:Sulbactam / Q000009:adverse effects / Q000627:therapeutic use
D005839:Gentamicins; D002981:Clindamycin; C035444:sultamicillin; D002440:Cefoxitin; D000667:Ampicillin; D004318:Doxycycline; D013407:Sulbactam