A randomized, prospective study comparing once-daily gentamicin versus thrice-daily gentamicin in the treatment of puerperal infection,☆☆,

Presented at the Seventeenth Annual Meeting of the Society of Perinatal Obstetricians, Anaheim, California, January 20-25, 1997.
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Abstract

OBJECTIVE: The efficacy, safety, and antibiotic-related charges for once-daily gentamicin with twice-daily clindamycin were compared with those of thrice-daily dosing of these antibiotics.

STUDY DESIGN: Patients with puerperal endometritis or with chorioamnionitis in labor assessed to be at risk for endometritis were randomized to receive gentamicin 4 mg/kg intravenously every 24 hours with clindamycin 1200 mg intravenously every 12 hours (experimental arm) or gentamicin 1.33 mg/kg intravenously and clindamycin 800 mg intravenously every 8 hours (conventional dosing interval arm). Primary outcomes included cure rates, mean length of treatment, antibiotic-related charges, and nephrotoxicity. Multiple logistic regression analysis was used to control for confounding variables.

RESULTS: There were 135 and 137 patients randomized to the experimental and conventional interval arms, respectively. Cures were obtained in 94.1% and 87.6% of patients in the experimental and conventional arms, respectively (p = 0.06). The experimental arm had mean antibiotic charges of $250.79 versus $442.49 in the conventional arm (p < 0.0001). There was no permanent nephrotoxicity in either group.

CONCLUSIONS: Once-daily gentamicin dosing with twice-daily clindamycin dosing is as efficacious and safe as the thrice-daily dosing of gentamicin and clindamycin for peripartum uterine infection. The experimental regimen results in substantial cost savings. The incidence of nephrotoxicity is low. (Am J Obstet Gynecol 1997;177:786-92.)

Section snippets

Material and methods

This experimental study was approved by the Institutional Review Board at Carolinas Medical Center in Charlotte, North Carolina. Patients on the resident obstetric service were enrolled in the study from July 1, 1994, to July 31, 1996, if they signed an informed consent form and met one of the following criteria: (1) two temperatures ≥100.4° F 6 hours apart excluding the first 12 postpartum hours, (2) a single temperature ≥102° F in first 12 postpartum hours, (3) a diagnosis of chorioamnionitis

Results

Two hundred ninety-nine patients were enrolled in the study. Twenty-seven were excluded for protocol violations: 9 did not meet enrollment criteria, 7 had inappropriate antibiotic changes before receiving 72 hours of the assigned treatment regimen, 8 patients never received study medications, and 3 patients had antibiotics discontinued before cure was achieved. This left 272 patients available for analysis. One hundred thirty-seven patients were randomized to the conventional arm and 135

Comment

Aminoglycosides are commonly used to treat upper genital tract infection because they provide reliable broad-spectrum bactericidal coverage against facultative aerobic gram-negative bacilli. Bacterial resistance to aminoglycosides is not common, and gentamicin is inexpensive because patent protection rights have expired. Nonetheless, some physicians are reluctant to use aminoglycosides because of the potential renal and ototoxicity. Many physicians who do use aminoglycosides feel compelled to

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From the Departments of Obstetrics and Gynecology and Research Planning and Evaluation, Carolinas Medical Center.

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