Abstract | BACKGROUND: OBJECTIVE: METHODS: This prospective, open-label study was conducted at a Veterans Affairs Medical Center. Male patients with diabetes and a lower-extremity infection were randomized to receive MTZ/CTX 1 g once daily or T/C 3.1 g every 6 hours. Treatment success was determined at 96 hours or on discontinuation of antibiotic. Success was measured in terms of body temperature <38.3 degrees C (100.6 degrees F), normalization of the finger-stick blood sugar concentration, improvement in wound staging, or a white blood cell count <10,000 cells/mm3. Medication acquisition costs per treatment arm were calculated and compared. RESULTS: Seventy patients were enrolled in the study (36 MTZ/CTX, 34 T/C). The study population had a mean (SD) age of 63.8 (10.8) years, a duration of diabetes of 12.4 (9.1) years, 0.5 (0.7) diabetes-related comorbidities, and an initial creatinine clearance of 67.1 (26.0) mL/min. There were no significant differences between groups at randomization. At 96 hours, treatment success was achieved in 31 (86%) patients in the MTZ/CTX group, compared with 28 (82%) patients in the T/C group (P=NS). Twenty-six patients were considered successfully treated on the final day of therapy in both the MTZ/CTX group (72%) and the T/C group (76%) (P=NS). There were no significant differences in primary or secondary measures of success between the 2 groups. No single or multiple baseline factors predicted treatment success or failure. No patient experienced adverse events considered related to study medication. MTZ/CTX was associated with savings of $61.06 per hospital admission, or $2198.05 for all patients who received this combination. CONCLUSION: In this population of older males, once-daily MTZ/CTX was as well tolerated and effective as T/C in the treatment of diabetic lower-extremity infections and was associated with reduced institutional costs.
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Authors | Patrick G Clay, Maqual R Graham, Cameron C Lindsey, Kenneth C Lamp, Collin Freeman, Alan Glaros |
Journal | The American journal of geriatric pharmacotherapy
(Am J Geriatr Pharmacother)
Vol. 2
Issue 3
Pg. 181-9
(Sep 2004)
ISSN: 1543-5946 [Print] United States |
PMID | 15561650
(Publication Type: Clinical Trial, Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Anti-Bacterial Agents
- Clavulanic Acids
- Drug Combinations
- Metronidazole
- Ceftriaxone
- ticarcillin-clavulanic acid
- Ticarcillin
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Topics |
- Aged
- Anti-Bacterial Agents
(adverse effects, economics, therapeutic use)
- Bacterial Infections
(drug therapy, etiology)
- Ceftriaxone
(administration & dosage, economics, therapeutic use)
- Clavulanic Acids
(administration & dosage, economics, therapeutic use)
- Cost Savings
- Diabetic Foot
(complications)
- Drug Administration Schedule
- Drug Combinations
- Drug Costs
- Drug Therapy, Combination
- Hospital Costs
- Hospitalization
- Humans
- Male
- Metronidazole
(administration & dosage, economics, therapeutic use)
- Prospective Studies
- Ticarcillin
(administration & dosage, economics, therapeutic use)
- Treatment Outcome
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