Health Condition 1: null- MRSA Infection Health Condition 2: A403- Sepsis due to Streptococcus pneumoniae
Conditions
Interventions
Intervention1: Arbekacin Sulphate: Arbekacin Sulphate 200mg OD belongs to class of broad spectrum antibiotics and will be used as interventional drug
Intervention2: Arbekacin Sulphate: Arbekacin Sulph
Sponsors
Alkem Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: •Patients who are able and are willing to comply with the protocol and have signed IEC/IRB approved Informed Consent Form. •Both male and female patients from 18 to 65 years of age. •Patients with negative pregnancy test confirmed by urine dipstick at enrollment. •Patients with normal Rinne and Weber test. •Once the patient has been diagnosed with MRSA infection and the same confirmed by a microbiologist in the conditions given below: ï?¼Post operative patients. ï?¼Systemic infections such as pneumonia (HAP and CAP). ï?¼Infections involving deeper soft tissues such as subcutaneous tissue, fascia, skeletal muscles, and bones. ï?¼Requiring significant surgical intervention such as infected ulcers, and deep abscess.
Exclusion criteria
Exclusion criteria: •Patients who are unable and are unwilling to sign IEC or IRB approved Informed Consent Form. •Patient has a history of allergy or serious adverse reaction to aminoglycoside antibiotics. •Patient is currently participating in another investigational new drug study. •Patient with medical conditions leading to difficulty in interpreting response such as polymicrobial infection. •Patient with meningitis / endocarditis. •Patient with impaired renal function test (Creatinine Clearance •Patients who test positive for hepatitis B, hepatitis C, HIV or human leucocyte antigen B-27. •Patients with positive pregnancy test confirmed by urine dipstick, or the intention to become pregnant within the next 30 days. •Lactating women •Co-morbid illnesses such as, severe congestive heart failure (CHF) or/and uncontrolled diabetes (HbA1c >8.9%, or fasting plasma glucose [FPG] >250 mg/dL) etc •Abnormal otoscopic findings, otologic surgery, autoimmune inner ear disease, significant air bone gaps, abnormal tympanograms, history of fluctuant hearing or asymmetry in hearing worse than 25 decibel (dB) at any test frequency and patients of epilepsy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety and efficacy of the drug Arbekacin Sulphate in patient diagnosed with MRSA infection including septicemia and pneumonia where Vancomycin Hydrochloride is indicated.Timepoint: The primary efficacy variables will be clinical outcomes in terms of 1) Clinical cure rate of infection at 3rd day of treatment,EOT/discontinuation & followup visit i.e. 7 (±2) days after EOT. 2) Microbiological cure rate of applicable culture(s) in evaluable patients at follow-up visit i.e. on 3 day after EOT. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the safety and tolerability of Investigational drugs including laboratory investigationsTimepoint: Day of screening, Day 3, day 7, end of treatment (EOT) & on follow up 7 (±2) days after EOT follow-up visit i.e. on 3rd day after EOT. | — |
Countries
India
Contacts
Public ContactMukesh Kumar
Alkem Laboratories Limited
Outcome results
None listed