Sulbactam/ampicillin versus cefoxitin for uncomplicated and complicated acute pelvic inflammatory disease.

In this study, 17 women were treated for uncomplicated acute pelvic inflammatory disease requiring hospitalisation for therapy, and 5 women were treated for the same infection complicated by pelvic abscesses. Treatment regimens were sulbactam 1g plus ampicillin 2g (14 women) or cefoxitin 2g (8 women) given by intravenous infusion every 6 hours. On the third day of therapy, a rash developed in 1 woman who was being successfully treated for uncomplicated disease with sulbactam/ampicillin. The other 21 women were cured. No other adverse clinical reactions and no significant abnormal laboratory results were observed with either regimen. Bacteriological efficacy, 98% for sulbactam/ampicillin and 94% for cefoxitin, closely paralleled clinical efficacy. Sulbactam, a suicide-type beta-lactamase inhibitor, appears to have restored and expanded the antibacterial activity of ampicillin.

Alterations in lower reproductive tract flora after single-dose piperacillin and triple-dose cefoxitin at vaginal and abdominal hysterectomy.

There are no current data regarding the effect of a newer, broad-spectrum penicillin on lower reproductive flora at hysterectomy. To identify any existing differential effect on species and their susceptibilities, we obtained pre- and postoperative lower reproductive tract culture material from 209 women who were given single-dose piperacillin, then placebo or triple-dose cefoxitin, intravenously for prophylaxis at vaginal and abdominal hysterectomy in a prospective, randomized, blinded clinical trial. Significantly more preoperative endocervical bacteria were susceptible to piperacillin. Piperacillin caused less alteration in the numbers of lower reproductive tract flora when preoperative species were compared with postoperative species. More resistance to cefoxitin was identified postoperatively in bacteria recovered from the vaginal cuff of women who remained uninfected.

Cefazolin for hysterectomy prophylaxis.

Efficacy data for single-dose cefazolin prophylaxis at hysterectomy are meager, and there are none evaluating the impact of route of administration on efficacy. For these reasons, 772 women undergoing elective abdominal or vaginal hysterectomy for benign diseases were given 1 g cefazolin either intramuscularly or intravenously in a randomized clinical trial. Preoperative diagnoses and clinical, surgical, and outcome variables were similar by route of administration for each surgical approach. Risk factors for infection after abdominal hysterectomy included younger age, lower postoperative hemoglobin concentration, and pelvic hematoma; women who developed infection after vaginal hysterectomy were heavier than those who remained uninfected and were more likely to have a pelvic hematoma. The overall incidence of major operative site infection requiring parenteral antimicrobial therapy in evaluable women was 7.2%: 7.6% for 539 women undergoing abdominal hysterectomy and 6.3% for 207 women undergoing vaginal hysterectomy. Postoperative infection was unrelated to route of cefazolin administration.

Single-dose cefoxitin prophylaxis for premenopausal women undergoing vaginal hysterectomy.

A prospective randomized blinded study was conducted comparing a single 2-g preoperative dose of cefoxitin with three 2-g doses of cefoxitin over 12 hours given to premenopausal women scheduled for vaginal hysterectomy in Parkland Memorial Hospital. The incidence of major pelvic infection in 58 women given one dose was 1.7%, and it was 3.7% for 54 women given three doses. The mean hospital stay (4.5 days) was similar for both regimens; for those who developed major infection it was eight days. More aerobic bacteria with altered species dominance and fewer anaerobic bacteria were recovered from the vaginal cuff at discharge from the hospital when compared with those recovered from the endocervix preoperatively. There was a trend toward increasing minimal inhibitory concentrations to cefoxitin in bacteria isolated after surgery, which was more frequent in women given three doses. There was not a statistically significant intergroup difference in the recovery of bacteria resistant to cefoxitin in vitro after surgery. A single preoperative dose of cefoxitin was as effective in preventing major infection as were three perioperative doses, while providing other real and theoretic benefits.

Cefotaxime sodium therapy for endomyometritis following cesarean section: dose-finding and comparative studies.

One hundred eighteen women who developed endomyometritis after cesarean section in Parkland Memorial Hospital were treated with parenteral cefotaxime sodium. The requirement for additional antimicrobial therapy was significantly higher at an initial daily dose of 3 g/day (16.4%) than when the dose was 6 g/day (4.8%) (P less than .05). The latter clinical efficacy and the observed in vitro susceptibility of 88% of isolates indicate that cefotaxime is well suited for single-agent parenteral therapy for this polymicrobial pelvic infection. Subsequently, 120 women with the same diagnosis were randomly treated with cefotaxime or clindamycin and gentamicin. Patient populations, surgical variables, in vitro microbiologic data, and side effects were similar for both groups. Clinical success observed was also similar: it was 97.5% for women given cefotaxime and 95% for women given clindamycin and gentamicin.

Cefoperazone and cefoxitin prophylaxis for abdominal hysterectomy.

One hundred one women undergoing elective abdominal hysterectomy were given perioperative cefoperazone or cefoxitin in a prospective randomized blinded study. Both regimens were well tolerated and no significant toxic or allergic manifestations were observed. Interrelationships between antimicrobial concentration in serum and pelvic tissues, intraoperative cardinal ligament cultures, febrile morbidity, and major postoperative infection were determined. At uterine removal, mean cefoperazone concentrations in serum (56.1 micrograms/mL) and pelvic tissues (18.6 micrograms/g) were significantly higher than mean concentrations of cefoxitin, ie, 16.1 micrograms/mL and 8.1 micrograms/g, respectively (P less than .001). The incidence of major postoperative infection was 6% or less with both regimens. Perioperative prophylaxis significantly reduced the incidence of this infection. When it did develop, however, it continued to cause significant morbidity, prolonging hospital stay a mean of more than four days (P less than .001) and increasing the hospital bill a mean of almost $1500 (P less than .001).

Upper and lower reproductive tract bacteria in 126 women with acute pelvic inflammatory disease. Microbial susceptibility and clinical response to four therapeutic regimens.

To more clearly understand the microbiology of acute salpingitis in our patients and to evaluate the clinical efficacy and safety of recommended and new therapeutic regimens, 126 women who met clinical diagnostic criteria for acute community-acquired pelvic inflammatory disease underwent endocervical and endometrial cultures prior to random intravenous therapy with cefoxitin plus doxycycline, ceftizoxime plus doxycycline or ceftizoxime alone (two regimens). Nine women (7%) had Chlamydia, and 70 (56%) had gonococci in endometrial specimens (P less than .001). Only two women (3.4%) given monotherapy required altered medical therapy, and none required surgery. Parenteral combination therapy was associated more frequently with adverse clinical and laboratory events.

Endometrial bacteria in asymptomatic, nonpregnant women.

The existence of normal lower reproductive tract flora has been recognized for many years. A study was conducted to identify the possible existence of upper reproductive tract (endometrial) bacteria in asymptomatic women with no history of previous pelvic infection and a normal pelvic examination. Bacteria were recovered from the endometria of 55 women with a double-lumen-catheter-protected brush; six cultures were sterile. Two hundred thirty-one bacterial species were present in 54 endocervical cultures. Type of contraception and phase of the menstrual cycle had no significant effect on the bacterial species recovered. Although contamination by cervical bacteria was possible, there was evidence of separate endometrial flora.

Single-dose antimicrobial prophylaxis at abdominal hysterectomy. Cefamandole vs. cefotaxime.

Two hundred twenty-three women were given a single, 1-g, intravenous dose of cefamandole or cefotaxime at elective abdominal hysterectomy in a multicenter, prospective, randomized, blind clinical trial of efficacy and safety. The demographic, surgical, efficacy and safety variables were statistically similar. Prior to discharge from the hospital, 12 women (5.3%) developed major postoperative pelvic infections that required parenteral antimicrobial therapy; no wound infections occurred. There was no correlation between a depressed antimicrobial development of significant postoperative infection. An expanded spectrum of antibacterial activity and a longer serum half-life did not improve clinical efficacy, and single-dose intravenous cephalosporin prophylaxis before abdominal hysterectomy was associated with a low incidence of pelvic infection.

Single-agent therapy for acute pelvic inflammatory disease: sulbactam/ampicillin versus cefoxitin.

A total of 54 women with acute salpingitis were treated intravenously with ampicillin/sulbactam or cefoxitin in a prospective, randomized, ongoing study. Of the organisms isolated, Gram-negative species (excluding Neisseria gonorrhoeae) were considerably more likely to produce beta-lactamase than were Gram-positive species. Clinical efficacy was 94% for 2 g ampicillin plus 1 g sulbactam and 89% for 2 g cefoxitin, all given intravenously every 6 h. The addition of sulbactam, an irreversible beta-lactamase inhibitor, to ampicillin restored both the microbiological and clinical activities of ampicillin. Both regimens were equally safe and demonstrated good efficacy in the treatment of the acute, symptomatic phase of infection.

Doxycycline and cefamandole prophylaxis for premenopausal women undergoing vaginal hysterectomy.

Fifty-one premenopausal women were given perioperative intravenous antimicrobial prophylaxis at vaginal hysterectomy in a prospective, blinded comparative study. Febrile morbidity developed in 14 women (27.4 per cent), but only nine (17.6 per cent) required antimicrobial treatment. The incidence of postoperative pelvic infection was 19.2 per cent for 26 women given 200 milligrams of doxycycline preoperatively and 16 per cent for 25 women given 5 grams of cefamandole in four doses over a period of 18 hours. Infections were polymicrobial, usually occurred during the initial hospitalization and significantly prolonged hospital stay (p less than 0.01). No variables were identified that allowed prediction of infection. A single dosage of doxycycline was as effective at preventing posthysterectomy pelvic infection as were multiple dosages of cefamandole.

Preoperative cefoxitin prophylaxis for elective abdominal hysterectomy.

Fifty women were randomly given one, two, or three 2 gm parenteral doses of cefoxitin with placebo blinding perioperatively at abdominal hysterectomy. A single preoperative intramuscular dose was more efficient, less frequently associated with the development of bacterial resistance, and less expensive than two or three doses.

Single-agent therapy for women with acute polymicrobial pelvic infections.

Pathogens that cause acute polymicrobial female pelvic infections usually do not differ from those that compose the normal flora of the lower reproductive tract. Accurate identification of these bacteria is difficult because cultures obtained via the lower tract can easily be contaminated. Although use of a double-lumen catheter-protected brush culture cannot completely eliminate the risk of contamination, it is the least invasive method for obtaining culture material from the upper reproductive tract. Compounding the problem of accurately identifying pathogens that cause acute upper tract infections is the fact that bacteria appear to be present in the upper tracts of asymptomatic women with normal examinations. Because of these problems and because of the polymicrobial nature of these infections, empiric therapy frequently includes more than one antimicrobial agent. Newer, semisynthetic penicillins and cephalosporins have expanded spectrums of in vitro activity against most of the bacteria frequently recovered from pelvic infection sites. Comparative clinical trials have shown these agents to be as effective when used alone as is combination therapy. With few exceptions, empiric monotherapy with one of these newer antimicrobials will be curative for women with acute upper tract infection, will have less potential toxicity, will require less space, materials, and manpower to administer, and will be less expensive.

Piperacillin and a combination of clindamycin and gentamicin for the treatment of hospital and community acquired acute pelvic infections including pelvic abscess.

Therapy for acute polymicrobial pelvic infections is empiric and must include predictable anaerobic coverage. Single agent therapy, if effective, is advantageous for the patient, nurses, pharmacy and hospital. Piperacillin sodium was compared with a combination of clindamycin and gentamicin as therapy for 63 female patients who were hospitalized with acute pelvic infections including pelvic abscess complicating community acquired salpingitis. Over-all clinical efficacy with piperacillin was 96.8 per cent and 90.3 per cent for clindamycin and gentamicin. Fewer bacteria demonstrated in vitro resistance to piperacillin (p = 0.008) and the cost of treatment for these infections was significantly less with piperacillin (p less than 0.05). Serious adverse reactions were not observed with either regimen. Piperacillin provides effective, cost-efficient therapy for women with acute polymicrobial pelvic infections.

Susceptibility profiles of potential aerobic and anaerobic pathogens isolated from hysterectomy patients.

A total of 1140 aerobic and anaerobic isolates were recovered from cultures of specimens from the reproductive tracts of 435 uninfected patients who underwent elective hysterectomy. Standard minimum inhibitory concentration susceptibility studies were performed on these isolates to 13 newer penicillins, cephalosporins, and some traditional antimicrobial agents. These data were generated to evaluate the in vitro efficacy of these antibiotics for potential use in prophylaxis or as a single agent for treatment of polymicrobial infections of the female pelvis. The minimum inhibitory concentration data for each antibiotic against 16 genera of aerobic and nine genera of anaerobic bacteria were determined and were used to compare the in vitro antimicrobial activity of newer antibiotics to that of the more traditional antibiotics. Of the antimicrobial agents tested, piperacillin had the highest in vitro activity against these isolates of any antibiotic tested.

Inpatient treatment for uncomplicated and complicated acute pelvic inflammatory disease: ampicillin/sulbactam vs. Cefoxitin.

OBJECTIVE: Ampicillin plus sulbactam, an irreversible beta-lactamase inhibitor, was compared to cefoxitin in the treatment of women with acute pelvic inflammatory disease (PID) with and without inflammatory mass(es). METHODS: Participation in an open, prospective, randomized clinical trial was offered to all women given the clinical diagnosis of acute PID who required inpatient therapy. Neisseria gonorrhoeae and Chlamydia trachomatis were sought in cervical and endometrial samples and aerobic and anaerobic species were sought in endometrial samples prior to treatment initiation. Treatment was given on at least 4 days and until women were afebrile for at least 48 h. Daily examinations were performed to assess response to therapy and safety. Only women in whom C. trachomatis was identified were discharged from the hospital on oral doxycycline to be taken for 10-14 days. RESULTS: One hundred twenty-four women were evaluated for safety; 117 (94%) were evaluated for efficacy. Demographic characteristics were similar for women in each treatment group. N. gonorrhoeae was recovered from 59% and C. trachomatis was recovered from 42% of study subjects. Inflammatory masses were identified in 35/76 (46%) women given ampicillin/sulbactam and 17/41 (41%) women given cefoxitin. Ampicillin/sulbactam cured 75 ,of 76 women (98.7%) [95% confidence interval (CI) 92.9-100.0%] and cefoxitin cured 37 of,41,omen (90.2%) (95% CI 76.9-97.3%) in that treatment regimen. CONCLUSIONS: Overall ampicillin/sulbactam was more effective (P = 0.05) than cefoxitin, due to superior efficacy in infection complicated by inflammatory mass(es).35/35 vs. 12/17 cured; P = 0.007).

A randomized trial of ofloxacin versus cefoxitin and doxycycline in the outpatient treatment of acute salpingitis.

The object of this randomized study was to compare the safety and efficacy of oral ofloxacin, 400 mg twice daily for 10 days, versus intramuscular cefoxitin, 2 gm, plus oral probenecid, 1 gm, followed by oral doxycycline, 100 mg twice daily for 10 days, in the outpatient treatment of uncomplicated acute salpingitis. Thirty-eight women (53%) had Neisseria gonorrhoeae from their pretreatment endocervical or endometrial cultures, and 18 had Chlamydia trachomatis (25%). Thirty-five of 37 women (95%) treated with the ofloxacin regimen were clinically cured, and 34 of 35 (97%) were cured with the cefoxitin-doxycycline regimen (p = 0.52). One clinical failure occurred in each group with N. gonorrhoeae infection, and one failure occurred in the ofloxacin group because of side effects. The bacteriologic response for N. gonorrhoeae in both groups was 100%. The eradication of C. trachomatis was 100% (10/10) for the cefoxitin/doxycycline group and 86% (6/7) for ofloxacin. The side effects were similar in both groups of subjects. In this study both regimens were effective for the outpatient treatment of uncomplicated acute salpingitis.

Cefazolin is inferior to cefotetan as single-dose prophylaxis for women undergoing elective total abdominal hysterectomy.

The purpose of this prospective, randomized, double-blind clinical trial was to compare the efficacy of 1-g doses of intravenous cefazolin with that of 1-g doses of intravenous cefotetan in preventing major operative site infections after elective abdominal hysterectomy. A major operative site infection requiring parenteral antimicrobial therapy developed in 46 (9%) of 511 evaluable women: 30 (11.6%) of 258 women given cefazolin prophylaxis and 16 (6.3%) of 253 women given cefotetan prophylaxis (relative risk, 1.84; 95% confidence interval, 1.03 to 3.29; P < .05). Risk factors for major operative site infection were younger age, lower postoperative hemoglobin concentration, and a proliferative endometrium. Ten (3.9%) of 258 women given cefazolin prophylaxis had a postoperative pelvic abscess; two of these women required additional surgical procedures, compared with two (0.8%) of 253 women given cefotetan prophylaxis who had an abscess but did not require surgery (relative risk, 4.9; 95% confidence interval, 1.09 to 22.16; P = .04). A greater number of infections and more serious infections occurred following cefazolin prophylaxis; this treatment resulted in 234 additional hospital days for administration of parenteral antimicrobial therapy.

Cefotaxime treatment for women with community-acquired pelvic abscesses.

Forty-one women with pelvic abscesses complicating salpingitis were treated with parenteral cefotaxime, a newer cephalosporin. Abscesses ranged in size from 4 by 4 to 13 by 15 cm, and in 10 women (24%) they were greater than or equal to 10 cm. Neisseria gonorrhoeae was recovered from the endocervix in 17 women (41%). A mean of 26.7 gm of cefotaxime was given over a mean of 6.5 days, and operation was not required during initial therapy. Only two women (5%) required the addition of another antimicrobial. Chronic pelvic pain and recurrent infection were infrequent during the 31- to 43-month follow-up period. Five women (12%) were readmitted for elective surgical therapy because of persistent or recurrent adnexal mass 1 to 33 months following study entry. Six (15%) women became pregnant and were delivered of their infants a mean of 25 months following cefotaxime therapy.