cefamandole and Endometritis

This study included 207 patients in a double-blind, prospective randomized trial of cefazolin versus cefamandole single-dose prophylaxis by both intravenous (IV) and lavage routes in patients laboring with ruptured membranes who eventually had nonelective cesareans. No significant differences (P less than .05) were noted in the rates of infectious morbidity (cefazolin IV: six of 47, 13%; cefazolin lavage: nine of 59, 15%; cefamandole IV: six of 47, 13%; cefamandole lavage: six of 54, 11%). The incidence of operative complications in the patients developing endometritis (eight of 22, 36%) was significantly different (P less than .004) from that in the group who did not develop endometritis (21 of 185, 11%). Cefazolin by IV and lavage routes of administration appears to be as effective as cefamandole by either route of administration.

Topics: Cefamandole; Cefazolin; Cesarean Section; Double-Blind Method; Endometritis; Female; Fetal Membranes, Premature Rupture; Humans; Incidence; Injections, Intravenous; Pregnancy; Prospective Studies; Puerperal Infection; Randomized Controlled Trials as Topic; Risk Factors; Therapeutic Irrigation

A randomized, prospective study compared a long-acting, second-generation cephalosporin, cefonicid (Monocid), with a short-acting, second-generation cephalosporin, cefoxitin (Mefoxin), for cesarean section prophylaxis. One hundred thirty-nine patients were enrolled, with 81 receiving a 1-g intravenous dose of cefonicid after cord clamping and 58 receiving a 2-g dose of intravenous cefoxitin after cord clamping and at 6, 12 and 18 hours postpartum. In those patients receiving cefonicid prophylaxis, endometritis incidence was 17.3% (14 of 81). This finding was not statistically significant (P less than .397) when compared to the 12.1% incidence of endometritis (7 of 58) with cefoxitin. In addition, the febrile morbidity incidence for cefonicid prophylaxis was 23.5% (19 of 81) as compared to 15.5% (9 of 58) for cefoxitin (P less than .25). Because the two drugs appear to be equally efficacious, cefonicid may be the better choice because of its markedly lower cost.

Topics: Adult; Age Factors; Cefamandole; Cefonicid; Cefoxitin; Cesarean Section; Endometritis; Female; Humans; Pregnancy; Prospective Studies; Random Allocation; Risk Factors; Socioeconomic Factors

The purpose of this prospective investigation was to compare a single intravenous dose of cefazolin to a single dose of cefonicid as prophylaxis for women having unscheduled cesarean delivery. In a double-blind, randomized design, 96 patients were assigned to receive a 1-g dose of cefazolin and 103 patients were designated to receive a 1-g dose of cefonicid. The antibiotics were administered after delivery of the infant. The two groups were comparable with respect to recognized risk factors for postcesarean infection. There were no statistically significant differences between the groups in the incidence of standard febrile morbidity, endomyometritis, urinary tract infection, wound infection, and bacteremia. There were also no significant differences between the groups in the fever index or the duration of hospitalization. We conclude that cefazolin and cefonicid provide a similar degree of prophylaxis against infection in patients having unscheduled cesarean delivery.

Topics: Bacterial Infections; Cefamandole; Cefazolin; Cefonicid; Cesarean Section; Double-Blind Method; Endometritis; Female; Humans; Injections, Intravenous; Pregnancy; Prospective Studies; Random Allocation

A randomized double-blind study was undertaken to determine which irrigation solution might be best at cesarean section. A saline placebo was compared with ampicillin sodium and one each of three generations of cephalosporins: cephapirin sodium, cefamandole nafate, and moxalactam disodium. A total of 360 cesarean sections were studied, and comparisons made between antibiotic and control groups relative to demographics, possible risk factors, and multiple measures of postoperative morbidity. The total group was further divided into high- and low-risk labor and repeat cesarean groups. Post-cesarean endometritis was diagnosed in the following frequencies for the group as a whole: placebo (24.6%), ampicillin sodium (8.5%), cephapirin sodium (11.4%), cefamandole nafate (4.6%), and moxalactam disodium (16.4%). Cefamandole nafate consistently demonstrated significant decreases in endometritis and other morbidity measures versus placebo both in laboring patients and the group as a whole.

Topics: Ampicillin; Cefamandole; Cephalosporins; Cephapirin; Cesarean Section; Double-Blind Method; Endometritis; Female; Humans; Moxalactam; Pregnancy; Premedication; Random Allocation; Solutions; Therapeutic Irrigation; Urinary Tract Infections

A randomized, prospective, double-blind study was designed to compare intravenous administration with intrauterine irrigation using an extended half-life (t1/2 = three hours) cephalosporin, ceforanide. Patients included in the study had a nonelective cesarean section with rupture of membranes for three hours or longer. Sixty-four patients received a single dose of ceforanide immediately after clamping the umbilical cord. Patients were similar in both groups in age, weight, length of labor, and duration of ruptured membranes. The group receiving the intravenous ceforanide had a significantly shorter duration of surgery than the patients receiving the intrauterine ceforanide. Endometritis infection rates were similar, 11.8% (intravenous) versus 11.1% (intrauterine), P greater than .1. Serum levels were as much as tenfold higher in the intravenous group versus the intrauterine group. Intrauterine irrigation with an antimicrobial agent provided no advantage over systemic administration.

Topics: Adult; Cefamandole; Cesarean Section; Clinical Trials as Topic; Double-Blind Method; Endometritis; Female; Humans; Injections, Intravenous; Postoperative Complications; Pregnancy; Premedication; Random Allocation; Risk; Therapeutic Irrigation; Urinary Tract Infections; Uterus

After double-blind controlled studies demonstrated cefamandole nafate irrigation of the uterus during cesarean section to be effective in reducing the rate of endomyometritis, antibiotic irrigation was adopted as a standard procedure at Tripler Army Medical Center. The present study analyzes the outcome in patients undergoing cesarean section before (comparison group) and after (treatment group) routine use of antibiotic irrigation began. The incidence of endomyometritis in 100 patients from the comparison group was 20% and in 298 patients from the treatment group 1.7% (P less than .0001). Serum analysis for cefamandole nafate demonstrated little systemic absorption of the antibiotic. Cefamandole nafate intrauterine irrigation at cesarean section effectively prevents endomyometritis.

Topics: Adult; Cefamandole; Cephalosporins; Cesarean Section; Clinical Trials as Topic; Double-Blind Method; Endometritis; Female; Humans; Intraoperative Care; Pregnancy; Premedication; Puerperal Infection; Therapeutic Irrigation

To assess the effect of broad-spectrum antibiotic therapy upon vaginal colonization, we collected vaginal specimens for culturing at the end of therapy from 50 patients treated for postcesarean section endometritis. Infected patients had participated in a double-blind therapy protocol and had received either clindamycin plus gentamicin or cefamandole plus placebo. Repeat vaginal culturing was performed 6 weeks later. Similar vaginal specimens for culturing were collected from 25 control patients who also had undergone cesarean section but had not received antibiotics. Of 26 patients treated with cefamandole, 16 (62%) developed vaginal colonization with isolates resistant to that drug; of 24 patients treated with clindamycin-gentamicin, two (8%) developed isolates resistant to these agents (p less than 0.001). Among 25 control patients, there was only one isolate resistant to cefamandole and none resistant to clindamycin-gentamicin. Compared to controls, more antibiotic-treated patients developed isolates resistant to cefamandole (p = 0.001) and to clindamycin-gentamicin (p = 0.06). Colonization did not persist, and there were no late infections in this population.

Topics: Adult; Anti-Bacterial Agents; Cefamandole; Cesarean Section; Clindamycin; Double-Blind Method; Drug Resistance, Microbial; Endometritis; Female; Gentamicins; Humans; Pregnancy; Puerperal Infection; Random Allocation; Vagina

Among patients with endomyometritis after cesarean section, a double-blind comparison of clindamycin-gentamicin versus cefamandole-placebo therapy was performed. Study criteria were: exclusion--use of prophylactic antibiotics or allergy to the drugs used; entry--uterine tenderness, oral temperature greater than or equal to 101 degrees F, and leukocytosis. Uterine specimens for culture were obtained via a single-lumen transcervical catheter. Most common isolates were Bacteroides bivius, Escherichia coli, and anaerobic cocci. Bacteremia occurred in 9.0%. Therapy results were: [Chart: see text]. Therapeutic failures were defined as persistent fever despite 3 or more days of treatment. Among the six clindamycin-gentamicin therapeutic failures, one patient had a resistant organism, and one had a pelvic mass. Among the 13 cefamandole-placebo therapeutic failures, three patients had resistant organisms, and one had a pelvic mass. Cause of persistent fever was not evident in the other patients. Side effects that necessitated discontinuation of therapy were: clindamycin-gentamicin group--diarrhea (six), allergic response (one); cefamandole-placebo group--diarrhea (two), allergic response (one). If the common practice of excluding side-effect failures is followed, there were more cures in the clindamycin-gentamicin group (P = 0.06).

Topics: Adult; Cefamandole; Cephalosporins; Cesarean Section; Clindamycin; Double-Blind Method; Drug Resistance, Microbial; Drug Therapy, Combination; Endometritis; Female; Gentamicins; Humans; Pregnancy; Random Allocation; Surgical Wound Infection

The effectiveness of intrauterine irrigation with an antibiotic solution of cefamandole nafate in reducing the incidence of endometritis after cesarean section was studied in a prospective, double-blind fashion. Ninety patients who underwent cesarean section at Tripler Army Medical Center were divided into three equal groups. Each group received one of the following treatments at the time of operation: (1) intrauterine irrigation with the antibiotic solution, (2) irrigation with normal saline solution, or (3) no irrigation. The resulting incidences of endometritis were 0%, 26.7%, and 23.3%, respectively. Intrauterine irrigation with cefamandole nafate solution at the time of cesarean section significantly reduced the incidence of endometritis.

Topics: Cefamandole; Cephalosporins; Cesarean Section; Double-Blind Method; Endometritis; Female; Humans; Postoperative Complications; Pregnancy; Prospective Studies; Risk; Sodium Chloride; Therapeutic Irrigation

A total of 120 patients who were to be delivered by cesarean section and who were at high risk of postoperative infection received three doses of either cefamandole, cephalothin or placebo perioperatively. Maternal serum levels for both antibiotics were in the therapeutic range. Although both drugs reduced the incidence of febrile morbidity and endometritis, only cefamandole significantly reduced the fever index. Risk factors for postoperative infections were the presence of ruptured membranes, labor, and internal fetal monitoring. Cefamandole beneficially influenced all risk factors while cephalothin was able to reduce only the risk of ruptured membranes. When a new method for obtaining endometrial tissue was utilized, 50% of cultures were negative. There was no difference in the organisms isolated from patients with and without endometritis.

Topics: Adult; Cefamandole; Cephalosporins; Cephalothin; Cesarean Section; Clinical Trials as Topic; Drug Resistance, Microbial; Endometritis; Female; Fetal Blood; Fetal Membranes, Premature Rupture; Fetal Monitoring; Fever; Humans; Infant, Newborn; Labor, Obstetric; Pregnancy; Risk

Thirty patients at term undergoing cesarean section received intraoperative irrigation with either cefamandole, cephalothin, or ampicillin to prevent postoperative infection. Serum drug levels were measured at 15, 60 and 120 minutes after completion of irrigation. Serum levels at each sampling interval were highest for cefamandole and lowest for cephalothin. Les than 2% of the total drug dose was excreted in the urine during the first 2 postoperative hours. In most patients, maximum serum antibiotic concentrations exceeded minimal inhibitory concentrations for several recognized pelvic pathogens. It is concluded that the mechanism of action of intraoperative irrigation may in part be due to systemic absorption of antibiotic and not simply to a local effect on the endometrium. Moreover, the degree of systemic absorption may be sufficient to cause allergic drug reactions and to exert selective pressures for the emergence of drug-resistant microorganisms.

Topics: Adult; Ampicillin; Cefamandole; Cephalosporins; Cephalothin; Cesarean Section; Endometritis; Female; Humans; Intraoperative Care; Kinetics; Pregnancy; Premedication; Therapeutic Irrigation

The effectiveness of intrauterine irrigation during cesarean section with a solution of cefamandole nafate in reducing febrile morbidity was studied in a prospective double-blind fashion. Ninety patients who were undergoing cesarean section at Tripler Army Medical Center were randomized into three groups: (1) intrauterine irrigation with cefamandole nafate solution, (2) intrauterine irrigation with normal saline solution, and (3) no irrigation. Febrile morbidity was evaluated by means of a fever index. There was a statistically significant reduction in the fever index in the group that received intrauterine irrigation with cefamandole nafate. The incidences of clinically diagnosed endomyometritis in the three groups were 0%, 26.7%, and 23.3%, respectively. Prophylactic intrauterine irrigation with cefamandole nafate during cesarean section markedly reduces febrile morbidity, primarily by reducing the incidence of endomyometritis.

Topics: Cefamandole; Cephalosporins; Cesarean Section; Double-Blind Method; Endometritis; Female; Fever; Humans; Intraoperative Care; Postoperative Complications; Pregnancy; Prospective Studies; Puerperal Infection; Risk; Therapeutic Irrigation; Uterus

Sixty women with endometritis following cesarean section were treated with cefamandole (12 gm/day) alone. Specimens for culture were obtained by endometrial lavage and from peripheral blood. Minimum inhibitory concentrations were performed on anaerobes and enterococci by an agar dilution technique. Anaerobic organisms were isolated in 55 of 60 (91.7%) endometrial specimens. Bacteremia was documented in 12 patients (20%). Of 387 isolates from uterine cultures, 20 (5%) were resistant or had MIC's greater than or equal to 32 micrograms/ml. Ten patients (17%) were judged clinical failures and responded to additional antibiotics. Of 19 patients with Bacteroides fragilis or related species isolates in the uterus, three (15%) were judged as failures. Cefamandole was well tolerated and appears to be useful in the initial treatment of endomyometritis.

Topics: Adult; Bacterial Infections; Bacteroides fragilis; Bacteroides Infections; Cefamandole; Cephalosporins; Cesarean Section; Endometritis; Enterobacteriaceae Infections; Female; Humans; Postoperative Complications; Pregnancy; Staphylococcal Infections; Streptococcal Infections

Topics: Cefamandole; Cephalosporins; Cephalothin; Cesarean Section; Endometritis; Female; Humans; Pregnancy; Puerperal Infection

Increased understanding of bacterial infections of the pelvis has led to the frequent administration of double and triple antimicrobial chemotherapy for polymicrobial infections in hospitalized patients. This study evaluated the use of high-dose cefamandole as a single agent in the treatment of obstetric and gynecologic infections. Cefamandole was administered by intravenous infusion of 2 gm every 4 hours or, less often, every 3 hours. Twenty patients were entered into the study, 11 with postpartum endometritis and nine with pelvic inflammatory disease. Seventeen of the 20 patients (85%) were successfully treated; all failures were in the endometritis group. The aerobic organisms and the gram-positive anaerobic organisms isolated from these infections were susceptible in vitro to cefamandole at attainable serum concentrations. The bacteroides isolated were more resistant. The data suggest that high-dose cefamandole therapy is effective as a single agent for the majority of moderate obstetric and gynecologic infections.

Topics: Bacteria; Bacterial Infections; Bacteroides Infections; Cefamandole; Cephalosporins; Drug Resistance, Microbial; Endometritis; Female; Humans; Pelvic Inflammatory Disease

Cefamandole nafate is a derivative of 7-aminocephalosporanic acid which has been shown to have good in vitro activity against aerobes traditionally susceptible to cephalosporins as well as many anaerobes, including B. fragilis. One hundred women with obstetric or gynecologic infections completed treatment with cefamandole: 53 had post-cesarean section infections: 24, acute pelvic inflammatory disease: 16, posthysterectomy cuff cellulitis/abscess; and seven, vulvar or abdominal wound abscess. Almost 90% of these women had either polymicrobial aerobic/anaerobic bacterial infections or an anaerobic infection alone. Ninety women responded to cefamandole alone; in 10 cases chloramphenicol was added, but in addition five of these women required surgical therapy for eradication of infection. Mild to severe phlebitis at the infusion site that responded to conservative therapy was demonstrated in 14 women. Of 312 bacterial isolates from these women, 89% were sensitive to cefamandole at 32 microgram/ml, an easily achievable serum level; 93% of anaerobic streptococci, the most common isolates, were sensitive at 32 microgram/ml. Also, 90% of all Bacteroides species were susceptible at 32 microgram/ml; 82% of B. fragilis were susceptible at this concentration. These data indicate that cefamandole is safe and effective for treatment of women with polymicrobial pelvic infections but that approximately 5% of these women will require surgical exploration in addition to antimicrobial administration.

Topics: Abscess; Acute Disease; Bacterial Infections; Bacteroides Infections; Cefamandole; Cellulitis; Cephalosporins; Cesarean Section; Clostridium Infections; Endometritis; Enterobacteriaceae Infections; Female; Genital Diseases, Female; Humans; Hysterectomy; Peptococcus; Peptostreptococcus; Peritonitis; Pregnancy; Streptococcal Infections; Surgical Wound Infection; Vulvitis

Thirty-one patients with severe gram-negative bacterial infections were treated successfully with a combination of cefamandole nafate plus gentamicin or tobramycin. The patients were divided into two treatment groups: group 1 received low-dose therapy (80--100 mg of cefamandole nafate/kg per 24 hr plus 3 mg of either gentamicin or tobramycin/kg per 24 hr), and group 2 patients, who had suspected bacteremia, received high-dose therapy (170 mg of cefamandole nafate/kg per 24 hr plus 5 mg of either gentamicin or tobramycin/kg per 24 hr). All of the patients were clinically and bacteriologically cured of their primary infections. All four episodes of bacteremia were cleared within 24 hr after therapy was initiated. There was a uniform decrease in the rate of creatinine clearance which was slightly greater in group 2 patients; however, all creatinine clearance values were within the normal range and actually improved during therapy. There was no difference between the clearance values of the tobramycin-treated patients and gentamicin-treated patients. A few transient abnormalities in results of liver function tests occurred during the study. In one patient whose serum was positive for hepatitis-associated antigen, the alkaline phosphatase, aspartate aminotransferase, and bilirubin values were elevated on admisssion of the patient to the hospital, increased fivefold during therapy, and decreased to the base-line admission values six days after therapy; however, it is difficult to establish that this reaction was antibiotic-induced hepatic toxicity.

Topics: Adolescent; Adult; Aged; Anti-Bacterial Agents; Bacterial Infections; Cefamandole; Cephalosporins; Drug Therapy, Combination; Endometritis; Escherichia coli Infections; Female; Gentamicins; Humans; Klebsiella Infections; Klebsiella pneumoniae; Male; Middle Aged; Pneumonia; Proteus Infections; Proteus vulgaris; Pyelonephritis; Sepsis; Tobramycin