The efficacy and safety evaluation of ceftriaxone and sulbactam combination (1.5 gram) in patients with skin and soft tissue infections: an open label, parallel, randomized, prospective comparative trial

Not Applicable

Completed

• Conditions: Skin and soft tissue infections; Infections and Infestations

• Registration Number: ISRCTN76443564
• Lead Sponsor: Ranbaxy Laboratories Ltd (India)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-06-27
• Study Completion: 2007-12-31
• Last Update Posted: 8 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

1. Male and female patients aged >18 years
2. Diagnosis of skin and skin structure infections of sufficient severity and with signs of systemic illness requiring injectable antibiotics. The diagnosis of Skin and Soft Tissue Infections (SSTI) should be made on the basis of clinical and microbiological criteria as follows:
a. Infection that involves soft tissue (including deep and extensive cellulitis; abscesses, necrotizing fasciitis, surgical site infections; burns [<10% of total body surface area]) or
b. Requiring surgical interventions or
c. Associated with significant underlying disease/s such as diabetes mellitus, peripheral vascular disease, peripheral neuropathy or venous insufficiency.
A surgical intervention is not necessary for entering this study, but it will be allowed at the start of the study.
3. At least two of the following signs and symptoms:
3.1. Drainage or discharge
3.2. Fever (oral temperature >38.50 °C or 101.40 °F)
3.3. Erythema
3.4. Swelling / fluctuation
3.5. Local warmth
3.6. Pain / tenderness
3.7. White Blood Cell (WBC) count of >10.0000 cells / mm3
4. Patients of SSTI requiring parenteral antibiotic administration for minimum of 5 days
5. All patient should have a microbiological specimen (culture material) obtained from skin lesions prior initiation of therapy

Exclusion Criteria

1. Unwilling or unable to give informed consent
2. Female patients of childbearing potential who are not practicing a reliable form of contraception
3. Significant mental retardation
4. Less than 18 years old
5. Hypersensitivity to ceftriaxone, sulbactam or any other beta-lactam agents
6. Presenting with sustained shock (Systolic Blood Pressure (SBP) <90 mm Hg for 2 hours, despite adequate fluid resuscitation)
7. Concomitant infection that requires treatment with another antimicrobial agent
8. Pseudomonas aeruginosa as a baseline isolate
9. Severely impaired arterial blood supply and insufficiency (absence of arterial pulse) such that the likelihood of amputation of the infected anatomical site is within one month
10. Presence of hepatic disease, acute hepatic failure or acute decompensation of chronic hepatic failure
11. Abnormal laboratory values at admission to study:
11.1. Serum Glutamic-Oxaloacetic Transaminase (SGOT), Serum Glutamic Pyruvic Transaminase (SGPT) >45 IU
11.2. Alkaline phosphate or serum bilirubin >2 mg/dl
11.3. Hemoglobin <9 g/dl, WBC<1000 /mm3
11.4. Platelet count < 75000 /mm3
12. Impaired renal function (serum creatinine >1.5 ml/min) or those requiring peritoneal dialysis or hemodialysis
13. Use of other antimicrobial drugs after wound specimen for culture has been obtained. Prior anti-infective use, (<3 days of oral antibiotics and <1 day any injectable antibiotics) even up to the day of patient enrollment, would be acceptable if a culture is obtained showing the persistence of pathogen.
14. Clinical laboratory determinations outside of an acceptable range should be excluded unless the finding can be attributed to current drug(s) therapy
15. Patients requiring further surgical intervention that might influence the evaluation of response to study medication
16. Any other underlying conditions compromising the ability to respond to a bacterial infection. e.g. AIDS, corticosteroid, chemotherapy, immunocompromised.
17. Any concomitant condition that, in the opinion of the investigator, would preclude an evaluation of a response or make it unlikely that the contemplated course of therapy could be completed
18. Any patient not reasonably expected to complete the trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified