Health Condition 1: null- adult subjects with uncomplicated Staphylococcus aureus skin and skin structure infections will participate in this study
Conditions
Interventions
Intervention1: Lysostaphin 120 µg/gel: Lysostaphin 120 µg/gel applied topically twice daily for 10 days + Standard treatment (Ampicillin + Cloxacillin 500mg QID) from day 1 for10±2 days.
Interventi
Sponsors
Council of Scientific and Industrial Research
Bharat Biotech International Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1Subjects 18 years and above, of either sex 2Informed consent given in written form 3Should have a confirmed uncomplicated Staphylococcus aureus skin and skin structure (wounds, burns, ulcer, abscess, etc) infection of not less than 2 cm2 and no more than 60 cm2 area over assessable and evaluable site of body. 4.Signs and symptoms consistent with infection (pain out of proportion to clinical findings, tenderness on palpation, swelling, erythema, indurations and pus formation -at least three of these should be present. 5.All subjects regardless of the disease type should have appropriate cultures obtained with Staphylococcus aureus isolate and susceptible to lysostaphin. 6.Women of child bearing age must have a negative urine pregnancy test and should agree to use effective contraceptive measures during study. 7.Post operative uncomplicated surgical wound
Exclusion criteria
Exclusion criteria: Exclusion Criteria: History: 1. Cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease. 2.Alcohol dependence, alcohol abuse or drug abuse within past one year. 3.Moderate to heavy smoking (10 cigarettes/day) 4.Clinically significant illness within 4 weeks before the start of the study 5.Asthma, urticaria or other allergic type reactions after taking any medication. 6.Subject with diabetes. 7.Positive HIV, Hepatitis B & C tests. 8.Any history of hypersensitivity to study drugs 9.Subjects with necrotizing mastitis, gas gangrene and osteomyelitisSite of infection other than skin like bacteramia, endocardites and meningitis. 10.Subject treated with previous antibiotics (systemic or topical) with Staphylococcus aureus activity for 24 hours and treatment extending in to 72 hours prior to first dose of study drug. Unless documented to be a treatment failure (72 hours of treatment and not responding) 11.Prior isolation of Staphylococcus aureus with resistance to lysostaphin. 12.Infections that have high cure rate after surgical incision alone should not be Included in the study. 13.Subject who has participated in any other clinical trial or bioequivalence study involving drug administration and collection of blood samples or has donated blood in the preceding 12 weeks period of the study. Subjects who have: 1.Systolic blood pressure less than 90 mm of Hg and more than 150 mm of Hg 2.Diastolic blood pressure less than 60 mm of Hg and more than 94 mm of Hg. Minor deviations (1-3 mm Hg) at check-in may be acceptable at the discretion of the physician /investigator. 3.Pulse rate below 50/minute and above 105/minute
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1Complete eradication of the organism and the time taken for the complete eradication. 2 Microbiological assessment for Staphylococcus aureus on 4th, 6th day of treatment, and at end of treatment 11±2 days and 21±2 days after first application (End of study) NOTE: End of treatment response to assess the effectiveness of the treatment to eliminate the infection. End of study at 21±2 days post treatment to assess the effectiveness of the treatment to prevent relapses Timepoint: three weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of safety by Adverse Event monitoring throughout the study period. Immunological response at baseline and 21±2st day after first application. Clinical response with rate of healing of lesion on 4,6,11±2 & 21st day Timepoint: Three weeks | — |
Countries
India
Contacts
Public ContactDr K venkatesh
Bharat Biotech International Ltd
Outcome results
None listed