Skin and soft tissue infections Infections and Infestations Skin and soft tissue infections
Conditions
Interventions
Intervention group: Ceftriaxone (1 gram) and sulbactam (0.5 gram) every 12 hours for maximum of 7 days
Control group: Ceftriaxone (1 gram) every 12 hours for maximum of 7 days
Sponsors
Ranbaxy Laboratories Ltd (India)
Eligibility
Sex/Gender
All
Inclusion criteria
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 [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
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) 45 IU 11.2. Alkaline phosphate or serum bilirubin >2 mg/dl 11.3. Hemoglobin 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical cure: The criterion for the clinical cure requires total resolution of all signs and symptoms of the infection associated with complete healing of lesions (i.e. lesions disappear or are completely dry), or improvement of the above to such an extent that no further antimicrobial therapy is necessary, as assessed at the end of therapy. Clinical assessments will be carried out four times during the trial period: on admission into the study (Day 1), therapy assessment on Day 3 and Day 5, and end of therapy at Day 7. The following sings and symptoms are examined during follow up visits for clinical response: 1. Fever 2. Chills 3. Malaise 4. Number of lesions 5. Length and width of largest lesion 6. Pain at the site of lesion 7. Ulceration of lesion 8. Type of discharge 9. Crust/scrub formation 10. Erythema around lesion 11. Warmth 12. Tenderness 13. Induration 14. Regional lymphadenopathy 15. New lesions | — |
Secondary
| Measure | Time frame |
|---|---|
| Bacteriological cure: The secondary efficacy measure is microbiological outcome. To be considered microbiologically evaluable, patients should be clinically evaluable, have microbiological diagnosis based on isolation of a susceptible pathogen in the wound culture at study admission and should have end of therapy (Day 7) microbiological assessments. Microbiological outcome will be classified as follows: Eradication: The absence of original pathogen(s) from post treatment wound culture performed at the end of therapy assessment. Presumed Eradication: Presumed eradication of pathogen(s) isolated at study admission in the absence of a repeat wound culture due to inability to perform sampling at the end-of therapy assessment and definition of clinical cure/improvement is met. Persistence: Lack of eradication of the original pathogen(s) isolated at the post treatment wound culture at the end of therapy assessments. Presumed persistence: In a patient who is judged to be clinical failure, and wound culture is not possible or is not done, it is presumed that there is persistence of the pathogen. Indeterminate: Wound culture was negative at study admission, or culture was not done at the end-of-therapy assessment even if the lesion has not healed at that assessment. Super Infection: Isolation of a pathogen other than the original pathogen from post-treatment wound culture at the end-of therapy assessment. | — |
Countries
India
Outcome results
None listed