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Topical nicotinamide compared with clindamycin gel in the treatment of inflammatory acne vulgaris.

BACKGROUND: Systemic and topical antimicrobials are effective in the treatment of inflammatory acne vulgaris; however, widespread use of these agents is becoming increasingly associated with the emergence of resistant pathogens raising concerns about microorganism resistance and highlighting the need for alternative nonantimicrobial agents for the treatment of acne. Nicotinamide gel provides potent antiinflammatory activity without the risk of inducing bacterial resistance. METHODS: In our double-blind investigation, the safety and efficacy of topically applied 4% nicotinamide gel was compared to 1% clindamycin gel for the treatment of moderate inflammatory acne vulgaris. Seventy-six patients were randomly assigned to apply either 4% nicotinamide gel (n = 38) or 1% clindamycin gel (n = 38) twice daily for 8 weeks. Efficacy was evaluated at 4 and 8 weeks using a Physician's Global Evaluation, Acne Lesion Counts, and an Acne Severity Rating. RESULTS: After 8 weeks, both treatments produced comparable (P = 0.19) beneficial results in the Physician's Global Evaluation of Inflammatory Acne; 82% of the patients treated with nicotinamide gel and 68% treated with clindamycin gel were improved. Both treatments produced statistically similar reductions in acne lesions (papules/pustules; -60%, nicotinamide vs. -43%, clindamycin, P = 0.168), and acne severity (-52% nicotinamide group vs. -38% clindamycin group, P = 0.161). CONCLUSIONS: These data demonstrate that 4% nicotinamide gel is of comparable efficacy to 1% clindamycin gel in the treatment of acne vulgaris. Because topical clindamycin, like other antimicrobials, is associated with emergence of resistant microorganisms, nicotinamide gel is a desirable alternative treatment for acne vulgaris.

Acne Vulgaris↗

Effect of clindamycin prophylaxis on the colonic microflora in patients undergoing colorectal surgery.

Clindamycin was given intravenously to 15 patients undergoing colorectal surgery in an initial dose of 600 mg, given at induction of anesthesia followed by 6 doses of 600 mg at 8-h intervals. Series of serum samples and fecal specimens were taken for analysis of clindamycin concentrations. Tissue samples from the gut wall were taken at surgery. The highest serum concentrations observed occurred 30 min after administration of clindamycin and varied between 6.8 and 37.9 microgram/ml (mean, 14.8 +/- 2.0 [standard error] microgram/ml). The clindamycin concentrations in the tissue samples were between 1.8 and 13.0 microgram/g. Clindamycin concentration in the fecal samples varied between 2.1 and 460 microgram/g. Fecal samples were also collected during the investigation period for cultivation of aerobic and anaerobic bacteria. Among the aerobic bacteria, enterococci and streptococci decreased during the prophylaxis period. Anaerobic bacteria also decreased significantly during the same period. After the clindamycin administration period, enterococci, streptococci and anaerobic bacteria proliferated. No anaerobic strains resistant to clindamycin were isolated. Postoperative infections due to Streptococcus faecalis and different enterobacteria such as Escherichia coli, Enterobacter cloacae, Citrobacter freundii, and Klebsiella occurred in five patients.

Adult↗

Clindamycin in a murine model of toxoplasmic encephalitis.

We investigated the efficacy of clindamycin in a murine model of toxoplasmic encephalitis using direct intracerebral inoculation. Clindamycin reduced mortality from 40% in normal mice and 100% in cortisone-treated mice to 0% in both groups. Although we were unable to document appreciable levels of clindamycin in the brains of infected mice, the histological features of cerebral infection were markedly altered. The formation of large numbers of cysts and the intense inflammatory response seen in the brains of normal mice and the unchecked infection and tissue necrosis in the brains of cortisone-treated mice were absent in the brains of clindamycin-treated mice. Enumeration of cysts in the brains of mice 10 weeks after infection revealed a significantly lower number in the clindamycin-treated mice. Spread of infection to other organs was also decreased during clindamycin administration. These observations suggest that clindamycin may have a role in the therapy of toxoplasmic encephalitis.

Animals↗

Activity of fleroxacin alone and in combination with clindamycin or metronidazole in experimental intra-abdominal abscesses.

To assess the potential efficacy of fleroxacin in combination with clindamycin or metronidazole in mixed aerobic and anaerobic infections, we used a rat model of intra-abdominal abscesses in which the inoculum consisted of pooled rat feces mixed with BaSO4. Two hours after bacterial challenge, antimicrobial therapy was begun intravenously with regimens designed to stimulate human pharmacokinetics. A combination of clindamycin and gentamicin was included as an established treatment regimen. After 8.5 days of therapy, final bacterial counts in abscesses showed that fleroxacin alone or combined with metronidazole or clindamycin effectively eradicated Escherichia coli, with bacterial densities of < or = 2.84 +/- 0.1, < or = 2.9 +/- 0.1, and < or = 2.9 +/- 0.1 (mean +/- standard error of the mean) log10 CFU/g, respectively. The addition of either clindamycin or metronidazole to fleroxacin substantially enhanced the effectiveness of the regimens against Bacteroides fragilis, with bacterial counts of < or = 3.0 +/- 0.1 or < or = 2.9 +/- 0.1 log10 CFU/g, respectively, versus 9.2 +/- 0.2 log10 CFU/g for fleroxacin alone. The combination of metronidazole and fleroxacin also resulted in a significantly greater reduction of peptostreptococci and Bacteroides thetaiotaomicron than fleroxacin alone (< or = 2.9 +/- 0.1 versus 6.1 +/- 0.9 log10 CFU/g and 3.3 +/- 0.4 versus 8.3 +/- 0.1 log10 CFU/g, respectively). Except for those of B. fragilis, counts of other anaerobes were reduced to a greater extent by metronidazole plus fleroxacin than by clindamycin plus fleroxacin, although differences were not always significant. Metronidazole plus fleroxacin was at least as active a clindamycin plus gentamicin against all species and was significantly more active against Clostridium spp. No regimen effectively eradicated enterococci from the abscesses. These results suggest that the addition of either metronidazole or clindamycin would effectively enhance the spectrum of fleroxacin for treatment of mixed aerobic and anaerobic infections.

Abdomen↗

Inducible clindamycin resistance and molecular epidemiologic trends of pediatric community-acquired methicillin-resistant Staphylococcus aureus in Dallas, Texas.

Community-acquired methicillin-resistant Staphylococcus aureus (CA-MRSA) infection occurs commonly in children. Clindamycin resistance may be inducible or constitutive, and the rates of inducible resistance in CA-MRSA that could produce clindamycin treatment failures vary worldwide. The double-disk test was performed in 197 erythromycin-resistant and clindamycin-susceptible CA-MRSA strains from children in Dallas, Texas, from 1999 to 2002 to determine inducible clindamycin resistance. Resistance mechanisms were studied by PCR; epidemiologic trends were studied by pulsed-field gel electrophoresis (PFGE) and multilocus sequence typing (MLST). Inducible resistance was demonstrated in 28 (93%+/-6%) of 30 tested isolates in 1999, 21 (64%, +/-11%) of 33 in 2000, 12 (23%+/-7%) of 52 in 2001, and 6 (7%+/-3%) of 82 in 2002. All noninducible strains had the msr(A) gene. Among inducible resistant strains, 31 had erm(B), 24 had erm(C), and 12 had erm(A) genes. Two distinct pulsed types were the most prevalent; one of them was the most common pulsed type in 1999, whereas in 2002 a different pulsed type was prevalent. MLST analyses determined that ST-8 was the most common type, with 76%+/-5% found in 2002. All but one of these clindamycin-susceptible, erythromycin-resistant ST-8 strains showed no induction of clindamycin resistance. We conclude that, among erythromycin-resistant, clindamycin-susceptible CA-MRSA strains isolated from children in Dallas, inducible methylase resistance became less common from 1999 to 2002 (P<0.001). The phenotype of strains was associated with their sequence type. Our results demonstrate a clonal shift in CA-MRSA in Dallas children from 1999 to 2002.

Adolescent↗

Interaction of clindamycin and gentamicin in vitro.

The minimal inhibitory concentrations of clindamycin and gentamicin alone and in combinations were determined by a microdilution method for 163 aerobic, facultative, and anaerobic clinical isolates. All 77 strains of Staphylococcus aureus, Diplococcus pneumoniae, Streptococcus pyogenes, and anaerobic bacteria (except for three strains of Clostridium) were inhibited by 1.6 mug or less of clindamycin per ml. Gentamicin did not interfere with the activity of clindamycin within the range of concentrations tested (0.1 to 100 mug/ml); for some strains combinations were synergistic. Sixty-two (94%) of 66 strains of Enterobacteriaceae and Pseudomonas aeruginosa were inhibited by 6.2 mug or less of gentamicin per ml. Combinations of clindamycin and gentamicin were indifferent for 29 strains and synergistic for 33 strains. All 20 strains of enterococcus, three strains of Clostridium, three strains of Escherichia coli, and one strain of Proteus rettgeri were resistant to both clindamycin (minimal inhibitory concentration greater than 3.1 mug/ml) and gentamicin (minimal inhibitory concentration greater than 6.2 mug/ml). Combinations of clindamycin and gentamicin were indifferent for 16 and synergistic for 11 of the resistant strains. Except for clindamycin-sensitive isolates, synergy was usually observed only at concentrations of one or both drugs which are not readily obtainable in vivo. Antagonism was never observed.

Anti-Bacterial Agents↗

The treatment of bacterial vaginosis with a 3 day course of 2% clindamycin cream: results of a multicentre, double blind, placebo controlled trial. B V Investigators Group.

OBJECTIVE: To evaluate the efficacy and safety of a 3 day course of intravaginal clindamycin 2% cream for the treatment of bacterial vaginosis. DESIGN: A prospective, randomised, double-blind placebo controlled study. SETTING: Departments of genitourinary medicine at Birmingham, Nottingham, Liverpool, Swansea, Leeds, Walsall, Stoke Mandeville, Southampton, Plymouth, Bishop's Stortford and Glasgow. SUBJECTS: Pre-menopausal women aged 18 years and over, who had symptomatic bacterial vaginosis were randomly allocated to receive either clindamycin 2% cream 5 grams (107 patients) or matching placebo cream (114 patients), daily for three days. Response to therapy was assessed at 7 days (Visit 2) and 28 days (Visit 3). RESULTS: 221 patients with symptomatic bacterial vaginosis were enrolled to the study and of these 141 (63.8%) completed the study. On the "intent-to-treat" (ITT) analysis, 75% of the clindamycin group were classified as "success" or "improved" at visit 2 compared with 13% of the placebo group (p < 0.001). At Visit 3, 41% of the clindamycin group were classified as either "success" or "improved" versus 4% in the placebo group (p < 0.001). Of the 80 patients who were recorded "success" or "improved" at visit 2, 20 (25%) were reported to have a "recurrence" of BV at Visit 3. The meta-analysis on those who were evaluable at Visit 2 and 3 also showed that clindamycin cream 2% was an effective treatment for bacterial vaginosis, and the differences between the clindamycin group and the placebo group were statistically significant. CONCLUSION: We conclude that a 3 day course of clindamycin 2% cream is an effective, and well tolerated treatment for bacterial vaginosis.

Administration, Intravaginal↗

Pharmacokinetic comparison of three clindamycin phosphate dosing schedules.

In a randomized, three-way crossover study, six male volunteers received clindamycin phosphate 600 mg iv q6h (treatment A), 600 mg iv q8h (treatment B), or 900 mg iv q8h (treatment C). Plasma clindamycin concentrations were determined periodically for eight hours after achieving steady state. The results indicate that treatment C yielded significantly higher peak plasma clindamycin concentrations than treatments A or B. There were no significant differences in minimum plasma clindamycin concentrations (Cmin) or area under the plasma concentration versus time curve (AUC24) between treatments A and C. However, both treatments A and C yielded significantly greater Cmin and AUC24 values than treatment B. There were no significant differences among treatments for clindamycin clearance. It is concluded that clindamycin phosphate 900 mg q8h is a pharmacokinetically acceptable alternative to clindamycin phosphate 600 mg q6h.

Adolescent↗

Efficacy of clindamycin hydrochloride in refractory periodontitis. 12-month results.

The purpose of this study was to evaluate the use of clindamycin hydrochloride as an adjunct to conventional periodontal therapy in the treatment of patients who had previously been unsuccessfully treated with scaling, periodontal surgery and the use of tetracycline. Thirteen patients with a history of "refractory" periodontitis were thoroughly scaled and monitored by repeated attachment level measurements for the presence of active destructive periodontitis. Disease activity was defined as a 3-mm loss in attachment from baseline measurements or the occurrence of a periodontal abscess. When active disease was detected, each patient was scaled again and placed on clindamycin hydrochloride 150 mg qid for 7 days. Following the adjunctive use of clindamycin in combination with scaling, the incidence of gingival sites demonstrating active disease in the group of 13 patients decreased from an annual rate of 10.7 to 0.5%. Each patient demonstrated a decreased incidence of active sites per unit of time. Clinical parameters such as probing depth, gingival redness, bleeding on probing and suppuration showed dramatic improvement at 12 months after clindamycin therapy. The percentage of pockets with probing depths greater than 6 mm, 4 to 6 mm and 1 to 3 mm changed from 11 to 2%, 38 to 24% and 51 to 74% respectively, following clindamycin therapy as compared to scaling alone. The percentage of sites bleeding on probing decreased from 33% after scaling alone to 8% following clindamycin and scaling. Gingival redness decreased from 36 to 1% of sites. Suppuration also decreased from 8% of buccal or lingual surfaces after scaling alone to 1% of surfaces following scaling and clindamycin.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗

Efficacy of clindamycin hydrochloride in refractory periodontitis: 24-month results.

The purpose of this investigation was to evaluate the use of clindamycin hydrochloride in the treatment of adult refractory periodontitis. Thirty patients with a history of unsuccessful treatment with scaling, periodontal surgery, and the use of tetracyclines were entered into the study. Upon entry, the suspected refractory patients were scaled several times and then monitored for the presence of active disease by probing attachment level measurements performed in duplicate. Active disease was defined as a 3.0 mm or greater loss in attachment from the baseline examination or the occurrence of a periodontal abscess. When active disease was detected, patients were treated with scaling and clindamycin 150 mg qid for 7 days. Patients served as their own controls. Twenty four patients demonstrated further attachment loss following scaling alone and were treated with clindamycin hydrochloride. Scaling and clindamycin treatment decreased the incidence of active disease from an annual rate of 8.0% to 0.5% of sites per patient (P less than .001). The mean time required to detect the first active site increased from 4.9 +/- 3.7 months following scaling alone to 16.7 +/- 7.6 months following scaling and clindamycin (P less than 001). Active sites lost an average of 3.1 mm of probing attachment following scaling alone but "gained" back 2.0 mm at 6 months and 1.5 mm at 24 months post-antibiotic and scaling treatment. Bleeding on probing was significantly reduced (P less than .05) from 31.8% of sites pre-clindamycin treatment to 12.3% at 12 months and 17.9% of sites at 24 months post-clindamycin treatment.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗

Prevalence of inducible clindamycin resistance in staphylococcal isolates at a Korean tertiary care hospital.

Clindamycin resistance in Staphylococcus species can be either constitutive or inducible. Inducible resistance cannot be detected by the conventional antimicrobial susceptibility test. In this study, we determined the prevalence of inducible clindamycin resistance in staphylococcal isolates at a Korean tertiary care hospital. Between February and September 2004, 1,519 isolates of Staphylococcus aureus and 1,043 isolates of coagulase-negative staphylococci (CNS) were tested for inducible resistance by the D-zone test. Overall, 17% of MRSA, 84% of MSSA, 37% of MRCNS, and 70% of MSCNS were susceptible to clindamycin. Of the erythromycin non-susceptible, clindamycin-susceptible isolates, 32% of MRSA, 35% of MSSA, 90% of MRCNS, and 94% of MSCNS had inducible clindamycin resistance. Inducible clindamycin resistance in staphylococci was highly prevalent in Korea. This study indicates importance of the D-zone test in detecting inducible clindamycin resistance in staphylococci to aid in the optimal treatment of patients.

Anti-Bacterial Agents↗

Impact of a target drug monitoring program on the usage of clindamycin.

The use of parenteral clindamycin at the Health Sciences Centre had not been amendable to traditional cost containment strategies. Clindamycin was targeted through a Target Drug Monitoring (TDM) Program to improve its appropriate use. A retrospective audit was conducted to serve as a baseline. In the concurrent phase, the TDM pharmacist reviewed and assessed clindamycin cases based on approved criteria. Those cases which failed to meet the criteria were targeted in order to convert clindamycin to alternative agents. The concurrent TDM program reviewed 339 cases of clindamycin over a 32-week period, of which 76 cases (22.4%) failed to meet the criteria and were targeted. Of the 76 recommendations, 48 (63.2%) were accepted. Cost-avoidance due to direct intervention was approximately $16,000 annualized compared to $28,000 estimated from the retrospective audit. Fiscal year-end antibiotic usage indicated a dramatic decline (32%) in clindamycin use. Net savings of $37,600 were attributed to modification of physician prescribing. The TDM program was successful in identifying areas of inappropriate clindamycin use and correcting them by direct interaction with the prescriber(s).

Adult↗

Bioavailability and selected pharmacokinetic parameters of clindamycin hydrochloride after administration of a new 600 mg tablet formulation.

The study was conducted to investigate the pharmacokinetics and relative bioavailability of clindamycin after administration of two oral clindamycin HCl formulations. A new tablet preparation containing 600 mg clindamycin (Clinda-saar 600, test) was compared to a marketed capsule containing 300 mg clindamycin (Sobelin 300, reference). Both preparations revealed comparable in vitro dissolution profiles with high batch conformity and homogeneity. Twenty healthy male volunteers received single doses of 600 mg clindamycin (test: 1 tablet, reference: 2 capsules) in an open, randomized, two-period crossover design. Blood samples were drawn up to 14 h p.a. and clindamycin plasma concentrations were measured using a sensitive and specific HPLC-UV method. Pharmacokinetic characteristics were similar for both preparations, arithmetic mean values (standard deviation) were computed as: AUC(0-infinity) 12.2 (4.2) and 13.1 (4.6) microg x h/ml, Cmax 3.1 (0.8) and 3.4 (0.8) microg/ml, t(max) 0.83 (0.24) and 0.85 (0.34) h, t(1/2) 2.3 (0.4) and 2.3 (0.6) h for test and reference, respectively. Mean relative bioavailability (point estimate) was 93% for AUC and 91% for Cmax. 90% confidence intervals for AUC and Cmax were within the predefined bioequivalence acceptance limits. Bioequivalence of test and reference preparations could be demonstrated. Single doses of 600 mg clindamycin orally were well tolerated without relevant differences between both preparations.

Administration, Oral↗

Treatment with 2% clindamycin vaginal cream prior to first trimester surgical abortion to reduce signs of postoperative infection: a prospective, double-blinded, placebo-controlled, multicenter study.

BACKGROUND: Bacterial vaginosis (BV) and intermediate flora is known risk-factor for postoperative infection after surgical termination of pregnancy. Vaginal application of 2% clindamycin cream is an efficacious treatment for BV, but it is not known whether preoperative administration of clindamycin cream might reduce the signs of post-abortion infection after surgical termination of pregnancy. AIM: To evaluate whether preoperative treatment with clindamycin cream might reduce the signs of post-abortion infection after legal abortion. DESIGN: Prospective, double-blinded, placebo-controlled, multicenter study. MATERIAL AND METHODS: Consecutive women attending for surgical termination prior to 11+4 gestational weeks were approached. We randomized participants to preoperative vaginal treatment with 2% clindamycin cream or placebo cream in a double-blinded fashion. At all visits vaginal smears were air dried on microscopy slides to be stored. The rate of postoperative pelvic infection according to our definition was the main outcome variable, the cure rates of BV and of intermediate flora were secondary outcome variables. RESULTS: Of 1655 enrolled women, 1102 were evaluable for analyses. Fifty-eight women developed signs of post-abortion infection. Preoperative treatment with clindamycin cream significantly (RR: 4.2, 95% C.I. 1.2-15.9) reduced the risk of post-abortion infection among women with abnormal vaginal flora (BV and intermediate flora). Treatment with clindamycin cream in women with normal lactobacilli flora did not demonstrate any difference compared to the non-treatment group. CONCLUSION: Preoperative treatment for at least three days with clindamycin cream significantly reduced the risk for developing signs of post-abortion infection only among women with preoperative abnormal vaginal flora (BV and intermediate flora).

Abortion, Induced↗

Clindamycin treatment of osteomyelitis and septic arthritis in children.

Forty-eight children, 1 month to 14 years of age, including 11 patients with untreated acute osteomyelitis, 8 with pretreated acute osteomyelitis, 12 with septic arthritis, and 11 with cellulitis or soft tissue abscess, were treated with clindamycin. Staphylococcus aureus was isolated from the blood, synovial fluid, bone, or soft tissues of 27 of these individuals while group A, beta-hemolytic streptococci or Clostridia were isolated from 9 patients. Clindamycin was provided intravenously until patients were afebrile for three days followed by orally administered clindamycin for one week in patients with cellulitis to as long as six months in patients with chronic osteomyelitis. Clinical and bacteriologic responses to treatment generally were excellent, most likely reflecting the excellent serum and tissue concentrations of clindamycin which were achieved. Serum concentrations of clindamycin following intravenous infusion at 20 to 30 mg/kg/day in three divided doses were 8- to 32-fold in excess of the minimal inhibitory concentrations of all organisms isolated in this study. Bone and synovial fluid concentrations of clindamycin were 60% to 85% of the serum concentrations measured concomitantly. Clindamycin provides an effective alternative treatment of osteomyelitis and septic arthritis in children who are sensitive to penicillin.

Abscess↗

Treatment of toxoplasmic encephalitis with intravenous clindamycin.

At present, therapy for toxoplasmic encephalitis (TE) is the combination of pyrimethamine with sulfadiazine or trisulfapyrimidines. Unfortunately, due to adverse reactions to sulfonamides, many patients with acquired immunodeficiency syndrome (AIDS) are unable to receive a complete course of therapy. The promising results with clindamycin phosphate therapy in a mouse model of TE prompted us to seek further information about patients with AIDS with TE who had been treated with clindamycin. Fifteen such patients were identified in whom clindamycin was used to treat 18 episodes of TE. Eleven patients showed clinical or radiologic improvement after receiving clindamycin therapy, either alone or in combination with pyrimethamine. Twelve received oral clindamycin as suppressive therapy after discharge from the hospital. Adverse reactions possibly related to clindamycin therapy included diarrhea, reversible granulocytopenia, and skin reactions. The results of this retrospective study suggest that clindamycin, either alone or in combination with pyrimethamine, may represent an effective alternative therapy for TE in patients with AIDS. Whether this supposition can be substantiated by appropriately designed studies is presently being determined.

Acquired Immunodeficiency Syndrome↗

Clindamycin pharmacokinetics and tissue penetration after head and neck surgery.

Penetration of clindamycin into surgical wounds was studied in 10 patients undergoing radical head and neck surgery. Patients received one preoperative and three postoperative intravenous doses of clindamycin 600 mg. During surgery, samples of plasma and sternocleidomastoid muscle were obtained. Additional plasma samples were collected just before the fourth dose of clindamycin, just after that dose was infused, and 1, 2, 4, 6, 8, and 12 hours after dosing. Samples of wound exudate were collected at 2, 4, 6, 8, and 12 hours after the fourth dose. The muscle, plasma, and wound exudate samples were assayed for clindamycin base by a gas-liquid chromatographic method. Plasma and wound exudate samples obtained during surgery and one and eight hours after the fourth dose were assayed by a radial immunodiffusion technique for content of alpha 1-acid glycoprotein (AAG), the major binding protein for clindamycin. Pharmacokinetic values for plasma and wound drainage were calculated and compared. Concentrations of clindamycin in muscle (three to six hours after the first dose) ranged from 0.6 to 5.1 micrograms/g; the ratio of tissue to plasma concentrations ranged from 0.24 to 0.82. The highest mean clindamycin concentration in wound drainage was 4.9 micrograms/mL after the fourth dose, approximately 90% of simultaneous plasma concentrations. Concentrations in wound exudate exceeded those measured in plasma four hours after the dose, and elimination from the wound was slower than from plasma. AAG concentrations in plasma increased from a mean of 89 mg/dL intraoperatively to 134 mg/dL postoperatively. AAG was present in wound exudate in concentrations that were approximately 53% of those observed in plasma.(ABSTRACT TRUNCATED AT 250 WORDS)

Aged↗

A prospective randomized study of moxalactam versus gentamicin and clindamycin in penetrating abdominal trauma.

We conducted a randomized, prospective study of moxalactam versus gentamicin plus clindamycin in 42 patients with penetrating abdominal trauma. Patients were randomized to receive intravenously either 2 grams of moxalactam every 12 hours or 80 milligrams of gentamicin every eight hours and 600 milligrams of clindamycin every six hours. Antibiotics were administered preoperatively and continued for a minimum of five days if hollow viscus injury occurred. For those without hollow viscus injury, only those patients receiving a minimum of three days of antibiotics were evaluated. A single intramuscular dose of 10 milligrams of vitamin K was also administered to all patients in the moxalactam group. There were 39 males and three females with a mean age of 33 years. Twenty patients received moxalactam and 22 received gentamicin plus clindamycin. The mechanism of injury was gunshot wound in 32 patients and stab wounds in ten patients. Eight patients in each group sustained injuries to the small intestine or colon, or both. The mean injury severity score was 22.6 and 21.2 in the single and double antibiotic regimen, respectively. The mean duration of antibiotic therapy was 5.8 and 7.0 days in the single and double antibiotic group, respectively. No infectious complications occurred in the moxalactam group whereas five infections occurred in four patients in the gentamicin plus clindamycin group (p less than 0.05). These infections included one intra-abdominal abscess, two wound infections and two episodes of necrotizing fasciitis of the wound and abdominal wall. There were no complications attributable to moxalactam therapy. The over-all mortality rate was zero per cent. The total pharmacy cost of a five day course of moxalactam plus a single dose of vitamin K is $204.67 compared with $226.00 for a similar course of gentamicin plus clindamycin. We conclude that: moxalactam is at least, if not more, effective in preventing infectious complications after penetrating abdominal trauma compared with gentamicin plus clindamycin; moxalactam is safe in the doses used when combined with vitamin K, and 3, moxalactam is more cost-effective than gentamicin plus clindamycin dual antibiotic therapy.

Abdominal Injuries↗