A randomized trial of three antibiotic regimens for the treatment of pyelonephritis in pregnancy. A comparative study of two antibiotic regimens for the treatment of operative site infections.
To compare the effectiveness of three antibiotic regimens for the treatment of acute pyelonephritis in pregnancy.
                One hundred seventy-nine pregnant women earlier than 24 weeks' gestation who had acute pyelonephritis were randomized to 1) intravenous (i.v.) ampicillin and gentamicin, 2) i.v. cefazolin, or 3) intramuscular ceftriaxone. All participants then completed 10-day courses of oral cephalexin after primary treatment. A urine culture was performed on admission and 5-14 days after completion of therapy. Surveillance for persistent or recurrent infection and obstetric complications continued until delivery. On the basis of a two-sided hypothesis test and with alpha = .025, 60 subjects were needed in each group for statistical power greater than 80% to detect a difference between ceftriaxone and other antibiotics if hospital length of stay differed by 1 or more days.
                The treatment groups were similar in age, parity, temperature, gestational age, and initial white blood cell count. There were no statistically significant differences in length of hospitalization, hours until becoming afebrile, days until resolution of costovertebral angle tenderness, or infecting organism. There were no statistically significant differences in birth outcomes between the three groups. The average (standard deviation) age at delivery was 38.8 +/- 3.6 weeks. The average birth weight was 3274 +/- 523 g. Eleven (6.9%) of 159 subjects delivered prematurely. Escherichia coli was the most common uropathogen isolated (137 of 179, 76.5%). Blood cultures were positive for organisms in 15 cases (8.4%). At follow-up examination within 2 weeks of initial therapy, eight (5.0%) of 159 subjects had urine cultures positive for organisms. Ten women (6.3%) had cultures positive for organisms later in their antepartum course, and 10 other participants (6.3%) developed recurrent pyelonephritis.
                There are no significant differences in clinical response to antimicrobial therapy or birth outcomes among subjects treated with ampicillin and gentamicin, cefazolin, or ceftriaxone for acute pyelonephritis in pregnancy before 24 weeks' gestation. This prospective study was designed to compare the relative efficacy of two antibiotic regimens for the treatment of operative site infections subsequent to pelvic operations. Patients with endomyoparametritis after delivery or pelvic cellulitis subsequent to hysterectomy were randomized to treatment with the combination of penicillin-gentamicin or the single agent cefoxitin. Seventeen of the 26 patients (65%) with endomyoparametritis who were treated with penicillin-gentamicin were cured by antibiotic therapy alone, in comparison to 15 of 23 (65%) patients treated with cefoxitin. Fifty-eight percent of the patients with pelvic cellulitis who were treated with penicillin-gentamicin responded favorably, in comparison to 50% of the patients treated with cefoxitin. None of these differences was statistically significant. In this study, neither antibiotic regimen provided satisfactory initial treatment for surgically induced soft tissue pelvic infection. Moreover, 11 of the 28 patients with treatment failures (40%) developed serious sequelae of their primary infection.
The number of women included in each of the comparisons is small and therefore, although no differences were detected between the different antibiotic regimens, the trials were limited in their ability to detect important but modest differences. For women who are allergic to penicillin, this review provides some reassurance that treatment with ceftriaxone or spectinomycin appears to have similar effectiveness in producing microbiological cure.
[Note: the one citation in the awaiting classification section of the review may alter the conclusions of the review once assessed.]