Randomized comparison of ampicillin-sulbactam to cefoxitin and doxycycline or clindamycin and gentamicin in the treatment of pelvic inflammatory disease or endometritis

J. A. McGregor, W. R. Crombleholme, E. Newton, Richard L Sweet, R. Tuomala, R. S. Gibbs

Research output: Contribution to journalArticle

24 Citations (Scopus)

Abstract

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 (χ2=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 (χ2=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. Conclusion: 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.

Original languageEnglish (US)
Pages (from-to)998-1004
Number of pages7
JournalObstetrics and Gynecology
Volume83
Issue number6
StatePublished - 1994

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Endometritis
Cefoxitin
Pelvic Inflammatory Disease
Clindamycin
Doxycycline
Gentamicins
Therapeutics
sultamicillin
Chlamydia
Postpartum Period
Multicenter Studies
Safety

ASJC Scopus subject areas

  • Obstetrics and Gynecology

Cite this

Randomized comparison of ampicillin-sulbactam to cefoxitin and doxycycline or clindamycin and gentamicin in the treatment of pelvic inflammatory disease or endometritis. / McGregor, J. A.; Crombleholme, W. R.; Newton, E.; Sweet, Richard L; Tuomala, R.; Gibbs, R. S.

In: Obstetrics and Gynecology, Vol. 83, No. 6, 1994, p. 998-1004.

Research output: Contribution to journalArticle

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abstract = "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 (χ2=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 (χ2=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. Conclusion: 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.",
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AU - McGregor, J. A.

AU - Crombleholme, W. R.

AU - Newton, E.

AU - Sweet, Richard L

AU - Tuomala, R.

AU - Gibbs, R. S.

PY - 1994

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N2 - 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 (χ2=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 (χ2=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. Conclusion: 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.

AB - 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 (χ2=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 (χ2=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. Conclusion: 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.

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