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Efficacy and safety study of fixed-dose combination of ceftriaxone-vancomycin injection in patients with various
Manu Chaudhary1, Sanjay Mohan Shrivastava, Rajesh Sehgal
1Intellectual Scientific Division, R & D Centre, Venus Remedies Limited, Haryana, India.
Abstract:
Pathogens can infect almost all tissues and cause serious infections. Objective was to evaluate efficacy and safety of fixed-dose combination of Ceftriaxone-Vancomycin in patients with various infections. Patients (n=305) suffering from different bacterial infections (serious respiratory tract disease, bronchitis, gastrointestinal tract infections, urinary tract infection, cellulites and meningitis) were enrolled. Patients were randomized into two groups depending on severity of illness. Group A (n=106) and Group B (n=199) patients were given intravenous dose of fixed-dose combination 1.5 g B.D. and 3.0 g B.D. respectively for 3-10 days. Hemoglobin, total leukocyte count, erythrocyte sedimentation rate, urea, creatinine levels serum glutamyl oxaloacetic transaminase and glutamyl pyruvic transaminase activities were recorded before and on completion of the treatment. Most of patients (70%) were cured in seven or less than seven days of the treatment. Significant decrease in total leukocyte count, erythrocyte sedimentation rate levels were observed indicating patients were cured from the infections. No significant alterations were observed in hemoglobin, serum urea, creatinine levels, glutamyl oxaloacetic transaminase and glutamyl pyruvic transaminase activities on completion of treatment. The fixed-dose combination of Ceftriaxone-Vancomycin, is found to be effective in treating various bacterial infections without any toxic effect on liver and kidney. Patients well tolerated the drug without major adverse effects.
Insights
The fixed-dose combination of Ceftriaxone-Vancomycin effectively treats various bacterial infections. This antibiotic combination showed significant improvement in patients with infections, with no observed liver or kidney toxicity.
Area of Science:
- Infectious Diseases
- Pharmacology
- Clinical Medicine
Background:
- Bacterial infections pose significant health risks across various tissues.
- Effective antimicrobial therapy is crucial for managing diverse infections.
- Evaluating fixed-dose combinations can optimize treatment regimens.
Purpose of the Study:
- To assess the efficacy and safety of a fixed-dose combination of Ceftriaxone-Vancomycin.
- To evaluate treatment outcomes in patients with multiple types of bacterial infections.
- To determine the impact of the combination therapy on key clinical and biochemical markers.
Main Methods:
- A randomized study involving 305 patients with bacterial infections.
- Patients received intravenous Ceftriaxone-Vancomycin at 1.5 g B.D. or 3.0 g B.D. for 3-10 days.
- Clinical cure rates and biochemical parameters (hemoglobin, leukocyte count, ESR, renal and liver function tests) were monitored.
Main Results:
- 70% of patients achieved cure within seven days.
- Significant reductions in total leukocyte count and erythrocyte sedimentation rate indicated infection resolution.
- No adverse effects on hemoglobin, urea, creatinine, or liver enzymes were observed.
Conclusions:
- The fixed-dose combination of Ceftriaxone-Vancomycin is an effective treatment for various bacterial infections.
- The therapy demonstrated a favorable safety profile, with no significant toxicity to the liver or kidneys.
- Patients tolerated the drug well, with minimal major adverse effects reported.
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