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PubMedDate not supplied

Aztreonam plus clindamycin versus tobramycin plus clindamycin in the treatment of intraabdominal infections.

In a multicenter, randomized clinical trial, aztreonam and tobramycin were compared for efficacy and safety in the treatment of intraabdominal infections. Patients were randomly assigned to one of the drug regimens, and all but two patients were treated concomitantly with clindamycin. Efficacy of treatment could not be evaluated for 107 of the 316 patients enrolled in the study. Among the 209 patients who could be evaluated (104 treated with aztreonam and 105 with tobramycin), microbiologic cure was achieved in 93% and 86%, respectively, and a favorable clinical response was noted in 85% of the patients in both groups. The frequency of adverse drug reactions in the two groups was similar. In this study, the efficacy and safety profiles of aztreonam plus clindamycin were comparable to those of tobramycin plus clindamycin.

Abdomen↗

PubMed1987

Surgically treated gangrenous or perforated appendicitis. A comparison of aztreonam and clindamycin versus gentamicin and clindamycin.

A randomized, double-blinded, controlled clinical study of 84 patients with surgically treated gangrenous or perforated appendicitis was done to compare the efficacy of the combination of aztreonam, the first monobactam antibiotic, with gentamicin when either was combined with clindamycin. Fifty-six patients who were treated with aztreonam and clindamycin (A/C) and 28 patients who were treated with gentamicin and clindamycin (G/C) fulfilled criteria for evaluation. A matched historic control group of 56 G/C patients was also included for comparison. All measures of outcome, including days of fever, hospitalization, antibiotic therapy, and the incidence of antibiotic failures, were similar. It was concluded that aztreonam was as effective as gentamicin in this study and may offer some advantages with regard to toxicity and serum drug level monitoring.

Adult↗

PubMed2005

Potential clindamycin resistance in clindamycin-susceptible, erythromycin-resistant Staphylococcus aureus: report of a clinical failure.

The erm gene product confers clindamycin resistance on Staphylococcus aureus. We report a clindamycin clinical failure where resistance developed on therapy in a D-test-positive strain. D tests of 91 clindamycin-susceptible, erythromycin-resistant S. aureus isolates showed that 68% of methicillin-susceptible and 12.3% of methicillin-resistant S. aureus strains were D-test positive.

Adult↗

PubMed2001

A combination benzoyl peroxide and clindamycin topical gel compared with benzoyl peroxide, clindamycin phosphate, and vehicle in the treatment of acne vulgaris.

A topical gel combining 5% benzoyl peroxide and 1% clindamycin as phosphate was evaluated in a 10-week randomized double-blind trial involving 287 patients with moderate to moderately severe acne. The combination agent demonstrated significantly greater reductions in inflammatory lesions than either of its active constituents (5% benzoyl peroxide and 1% clindamycin) or vehicle when used alone. Significantly greater reductions in comedos and improvements, as measured by both physicians' and patients' global evaluations, were obtained with the combination agent than with clindamycin or vehicle. The reduction in comedos and the global improvements were similar between the combination agent and benzoyl peroxide. The combination agent was well tolerated; the incidence of dry skin was similar to that found with benzoyl peroxide, and other adverse events were similar to that with vehicle. The improved efficacy obtained with combination therapy was accompanied by a safety profile similar to that of either constituent used alone.

Acne Vulgaris↗

PubMed1990

Efficacy of dactimicin plus clindamycin compared with gentamicin plus clindamycin in the treatment of experimental intra-abdominal infections in rats.

A reproducible experimental model of intra-abdominal infections in rats has been developed in order to simulate intra-abdominal sepsis in patients. A 1-cm segment of ileum was isolated on its vascular pedicle. The intestine was then divided at each end of the segment and intestinal continuity was re-established by an end-to-end anastomosis. Dactimicin is a new aminoglycoside antibiotic with a broad antibacterial spectrum including both aerobic Gram-positive and Gram-negative bacteria. The experimental model was used to compare the efficacy of dactimicin in combination with clindamycin with the combination gentamicin/clindamycin in the treatment of intra-abdominal infections. Of the untreated animals, 70% died within two days. Animals treated with dactimicin plus clindamycin or gentamicin plus clindamycin exhibited significantly decreased mortality and increased cure rates during the experimental period. Only 5% of these animals died. Thus the combination dactimicin/clindamycin seems to be useful in the treatment of intra-abdominal infections.

Abdomen↗

PubMedDate not supplied

Pharmacoeconomics of aztreonam-clindamycin versus gentamicin-clindamycin in the treatment of penetrating abdominal injury.

STUDY OBJECTIVE: To evaluate the pharmacoeconomic implications of using aztreonam-clindamycin (A-C) versus gentamicin-clindamycin (G-C) from the perspective of the hospital and pharmacy directors. DESIGN: Pharmacoeconomic analysis performed at one of the sites participating in the prospective, randomized, double-blind, comparative, multicenter efficacy study. SETTING: Referral hospital with level 1 trauma center. PATIENTS: Eight-five adults with a suspected penetrating intraabdominal injury requiring laparotomy. INTERVENTIONS: Patients were randomized to receive aztreonam 2 g intravenously every 8 hours or gentamicin 2 mg/kg intravenous load followed by 5 mg/kg/day intravenously initially adjusted to peak concentrations of 6-8 micrograms/ml. All patients received clindamycin 900 mg intravenously every 8 hours. MEASUREMENTS AND MAIN RESULTS: Charge data were gathered from the hospital billing system and converted to cost data using an institutional cost:charge ratio of 0.6. Study drug and aminoglycoside monitoring costs were also calculated. Overall, 43 (97%) of 44 patients receiving A-C had a favorable clinical response compared with 35 (85.4%) of 41 receiving G-C (p = 0.052). The mean hospital cost of $66,336 for 7 infected patients was significantly higher than that of $8014 in 78 noninfected patients (p < 0.0001). Mean hospital costs of $12,058 and $13,742 for A-C and G-C groups, respectively, were not significantly different (p > 0.05) despite having only a single failure (total cost $162,666) in the A-C group. Similarly, mean pharmacy costs of $1411 and $1604, respectively, were not significantly different (p > 0.05). CONCLUSIONS: Hospital costs for infected patients with penetrating abdominal trauma exceed those of noninfected patients by 5-fold. Despite a lower infection rate in the A-C group, neither hospital nor pharmacy costs were significantly different compared with those in the G-C group.

Abdominal Injuries↗

PubMed1997

High-performance liquid chromatographic determination of clindamycin in human plasma or serum: application to the bioequivalency study of clindamycin phosphate injections.

This paper presents an assay of clindamycin phosphate injection in human plasma or serum. A 0.5-ml volume of plasma was used with the internal standard, propranolol. The sample was loaded onto a silica extraction column. The column was washed with deionized water and then eluted with methanol. The eluates were evaporated under nitrogen gas. The residue was reconstituted with the mobile phase and injected onto the high-performance liquid chromatographic system: a 5-micron, 25 cm X 4.6 mm I.D. ODS2 column was used with acetonitrile, tetrahydrofuran and 0.05 M phosphate buffer as the mobile phase and with ultraviolet detection at 204 nm. A limit of quantitation of 0.05 microgram/ml was found, with a coefficient of variation of 11.6% (n = 6). The linear range is between 0.05 and 20.00 micrograms/ml and gives a coefficient of determination (r2) or 0.9992. The method has been successfully applied to the bioavailability study of two commercial preparations of clindamycin phosphate injection (300 mg each) in twelve healthy adult male volunteers.

Adult↗

PubMedDate not supplied

Aztreonam plus clindamycin vs. tobramycin plus clindamycin for the treatment of intraabdominal infections.

Sixty-six patients with acute intraabdominal infections due to gram-negative aerobic organisms were treated with aztreonam plus clindamycin or with tobramycin plus clindamycin in a multicenter, comparative, randomized study. The patients had undergone a variety of surgical procedures; most of them had peritonitis. Thirty-three of the 36 patients in the aztreonam group and 26 of the 30 patients in the tobramycin group had satisfactory clinical responses. Only one gram-negative aerobic pathogen, a strain of Pseudomonas aeruginosa, persisted after treatment; the patient involved was in the tobramycin group. The incidences of adverse reactions, superinfections, and abnormal laboratory values were low in each treatment group. The difference between the efficacies of the two regimens was not statistically significant. This study suggests that aztreonam may be a useful alternative to the aminoglycosides in the treatment of gram-negative intraabdominal infections.

Abdomen↗

PubMed2000

A multicentre, single-blind, randomized comparison of a fixed clindamycin phosphate/tretinoin gel formulation (Velac) applied once daily and a clindamycin lotion formulation (Dalacin T) applied twice daily in the topical treatment of acne vulgaris.

BACKGROUND: A successful phase III pilot study compared the efficacy and safety of a fixed clindamycin 1%/tretinoin 0.025% gel formulation (CTG; Velac gel) applied once daily and a clindamycin 1% lotion formulation (CLN; Dalacin T lotion) applied twice daily in the treatment of moderate to severe acne vulgaris. OBJECTIVES: We aimed to follow up this study. METHODS: The two treatment regimens were compared in a multicentre, single-blind, randomized 12-week investigation of patients with moderate to severe acne vulgaris. RESULTS: At week 12, the mean percentage reduction in non-inflamed lesions (open and closed comedones) was greater in the CTG group compared with the CLN group (P = 0.05). Absolute reductions in open and closed comedones were also greater in the CTG group, consistent with the comedolytic activity of tretinoin. There was a significantly greater absolute reduction in inflamed lesions (pustules, papules and nodules) from baseline to both end-point (last observed efficacy outcome; P = 0.043) and week 12 (P = 0.018) in the CTG group compared with the CLN group. Evaluation of the calculated overall acne severity score, considering all five lesion subtypes, demonstrated a significantly greater mean percentage reduction in the CTG group compared with the CLN group, both at end-point (P = 0.01) and at week 12 (P < 0.01). The more subjective assessment of overall acne severity according to the Cook scale also demonstrated a significantly greater mean reduction in the CTG group than the CLN group after 12 weeks of therapy (P = 0.007). CTG had a more rapid effect on the onset of improvement compared with CLN; a 50% reduction in total lesion counts by day 60 was found in 77% of patients on CTG compared with 56% receiving CLN (P = 0.003). This was largely due to the reduction in open comedone counts (P = 0. 0006). For all other variables, CTG was at least as effective as CLN. Both treatments were well tolerated. CONCLUSIONS: A single daily topical application of Velac gel was superior to Dalacin T lotion applied twice daily in reducing overall acne scores, and was faster acting. The simpler dosing regimen of Velac gel and its rapid effect are likely to have a positive effect on both patient compliance and cost.

Acne Vulgaris↗

PubMed1982

In vitro activity of pipecolic acid amide of clindamycin (U-57930E) on anaerobic bacteria compared with those of clindamycin, cefoxitin, and chloramphenicol.

In vitro activity of pipecolic acid amide of clindamycin (U-57930E) against 265 isolates of anaerobic bacteria, including 66 strains of Bacteroides fragilis, was compared with those of clindamycin, chloramphenicol, and cefoxitin. At therapeutically achievable concentrations, the activities of all four antibiotics against anaerobic bacteria were similar.

Bacteria, Anaerobic↗

PubMed1989

Comparison of aztreonam plus clindamycin with tobramycin plus clindamycin in the treatment of intra-abdominal infections.

The activity of aztreonam (a beta-lactam antibiotic with specific activity against gram-negative bacteria) was evaluated and compared with that of tobramycin in hospitalized patients with severe intra-abdominal infections due to gram-negative pathogens, either alone or in association with other bacteria. Of a total study population of 156 patients, 76 were assigned to treatment with aztreonam + clindamycin, and the remaining 80 were treated with tobramycin + clindamycin. Patients underwent a variety of surgical procedures involving the peritoneal cavity. The final clinical evaluation revealed similar percentages of satisfactory results: 86.8% for the patients in the aztreonam-treated group and 86.2% for the tobramycin-treated patients. Among the patients who had a poor therapeutic result, gram-negative bacteria, either alone or associated with gram-positive pathogens, were considered responsible for 50% of the infections in the aztreonam group; the percentage increased to 82% among those treated with tobramycin. The incidence of side effects and laboratory alterations was not significant and was similar in both groups. The results of this study suggest that aztreonam may be an effective and safe drug for the treatment of bacterial infections due to gram-negative pathogens.

Abdomen↗

PubMed1991

A randomized clinical trial of ampicillin, gentamicin and clindamycin versus cefotaxime and clindamycin in children with ruptured appendicitis.

This prospective, randomized, double-blind study compares the efficacy, safety and cost-effectiveness of ampicillin, gentamicin and clindamycin (AGC) or cefotaxime and clindamycin (CC) for the treatment of children with complicated appendicitis. Ninety-seven children were randomized. Forty-seven were assigned to the AGC regimen and 50 received CC. Forty-two patients in the AGC group had an appropriate therapeutic outcome, whereas 48 of 50 children who received CC completed the trial successfully (p = NS). There were no differences between the groups with reference to the duration of antibiotic administration, fever, leukocytosis or length of hospitalization. Complications of therapy were uncommon and neither regimen demonstrated a significant advantage from an economic standpoint. We concluded that, in childhood, complicated appendicitis can be treated with either CC or AGC with equal efficacy.

Adolescent↗

PubMed1995

A Double-Blind, Randomized Comparison of Aztreonam Plus Clindamycin with Tobramycin Plus Clindamycin in Abdominal Infections.

Seventy patients with intraabdominal infections were randomly assigned in double-blinded fashion to receive either the combination of tobramycin plus clindamycin (TM/C) or aztreonam plus clindamycin (AZ/C). Thirty-four patients received AZ/C and 36 were given TM/C. Average ages were 62 years (TM/C) and 66 years (AZ/C). In approximately one-half of both groups, the source of infection was perforated colon or perforated appendix. There were no significant differences in demographic factors between these groups, although those given AZ/C had a more serious long-term prognosis due to underlying diseases. The average lengths of treatment were 10 days (TM/C) and 9 days (AZ/C). Clinical response to therapy did not differ, as 84% of the TM/C patients and 78% of the AZ/C patients had satisfactory clinical responses. The two regimens differed in adverse effects, as an elevated PT/PTT was more frequently (p < 0.05) observed in AZ/C. All PT/PTT elevations responded to injections of vitamin K, and no serious bleeding occurred. Choice between these regimens depends on differences in cost and the risk of adverse effects, as both regimens appear equally effective for treatment of abdominal infections in conjunction with appropriate surgical intervention.

Journal Article↗

PubMed1999

Determination of clindamycin in human plasma by liquid chromatography-electrospray tandem mass spectrometry: application to the bioequivalence study of clindamycin.

A simple, sensitive and specific liquid chromatography-electrospray tandem mass spectrometry (LC-MS-MS) method for the determination of clindamycin (I) was developed. Both I and verapamil (II, internal standard) were analyzed using a C18 column with a mobile phase of 80% acetonitrile-0.01% trifluoroacetic acid. Column eluents were monitored by electrospray tandem mass spectrometry. Multiple reaction monitoring (MRM) using the parent to daughter combinations of m/z 425-->126 and 455-->165 was used to quantitate I. A limit of quantitation of 0.0500 microgram/ml was found. The assay exhibited a linear dynamic range of 0.0500-20.0 micrograms/ml and gave a correlation coefficient (r2) of 0.998 or better. The chromatographic run time was approximately 2 min. The intra-batch precision and accuracy of the quality controls (QCs, 0.0500, 0.150, 1.50, 15.0 and 20.0 micrograms/ml) were characterized by coefficients of variation (CVs) of 5.13 to 13.7% and relative errors (REs) of -4.34 to 4.58%, respectively. The inter-batch precision and accuracy of the QCs were characterized by CVs of 4.35 to 8.32% and REs of -10.8 to -4.17%, respectively. The method has successfully been applied to the analysis of samples taken up to 12 h after oral administration of 300 mg of I in healthy volunteers.

Anti-Bacterial Agents↗

PubMedDate not supplied