Health Condition 1: null- Uncomplicated Staphylococcus aureus and Methicillin resistant Staphylococcus aureus skin and skin structure infections
Conditions
Interventions
Intervention1: Lysostaphin: Anti-staphylococcus Recombinant Product. Dose (150ug/g) will be used. Lusostaphin will be applied topically twice daily for 10 days.
Control Intervention1: Mupirocin 2% cre
Sponsors
Bharat Biotech International Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Informed consent given in written form Should have a confirmed uncomplicated Staphylococcus aureus skin and skin structure (wounds, burns, ulcer, abscess). infection of not less than 2 cm2 and no more than 30 cm2.area over assessable and evaluable site of body. 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. All subjects regardless of the disease type should have appropriate culture obtained with Staphylococcus aureus isolates susceptible to both Lysostaphin and Mupirocin. Women of child bearing age must have a negative urine pregnancy test and should agree to use effective contraceptive measures during study.
Exclusion criteria
Exclusion criteria: I. Cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease. II. Alcohol dependence, alcohol abuse or drug abuse within past one year. III. Moderate to heavy smoking ( >10 cigarettes/day) or consumption of tobacco products IV. Clinically significant illness within 4 weeks before the start of the study V. Asthma, urticaria or other allergic type reactions after taking any medication. VI. Positive urine drug screening, HIV, Hepatitis B & C tests. VII. Any history of hypersensitivity to study drugs VIII. Subjects with necrotizing fastitis, gas gangrene and osteomyelitis IX. Site of infection other than skin like bacteramia, endocarditis and meningitis. X. 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) XI. Prior isolation of Staphylococcus aureus with resistance to lysostaphin and Mupirocin.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical response rate at 10±2 days at end of treatment (EOT). End of treatment response assess the effectiveness of the treatment to eliminate the infection.Timepoint: Clinical response rate at 10±2 days at end of treatment (EOT). End of treatment response assess the effectiveness of the treatment to eliminate the infection. | — |
Secondary
| Measure | Time frame |
|---|---|
| Microbiological eradication rate of Methicillin sensitive and resistant Staphylococcus aureus at 10±2 days at end of treatment (EOT) â?¢Clinical cure rate and microbiological relapse rate at end of study (EOS) 21±2 days after first application. End of study at 21±2 days post treatment assess the effectiveness of the treatment to prevent relapses. â?¢Adverse drug reaction monitoringTimepoint: on Day 0, 3, 6, 10 and 21 | — |
Countries
India
Contacts
Public ContactDr Binod Sah
Bharat Biotech International Ltd
Outcome results
None listed