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

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

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.