PHASE II OPEN LABEL, MULTI-CENTERIC CLINICAL TRIAL OF ORAL WCK 2349(1000 mg BID and 1200 mg BID)TO EVALUATE SAFETY AND EFFICACY IN THE TREATMENT OF COMPLICATED SKIN AND SOFT TISSUE INFECTIONS CAUSED BY GRAM POSITIVE BACTERIA.
- Conditions
- Health Condition 1: null- Patient of cSSTIs caused by Gm+ve bacteria, including MRSA.
- Registration Number
- CTRI/2011/09/002012
- Lead Sponsor
- Wockhardt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 120
1.Subjects of either sex with 18 -70 years of age.
2.Weighing at least 40 kgs
3.Clinical diagnosis of cSSTIs as one of the conditions given below
(i)infections involving deeper soft tissues such as subcutaneous tissue, fascia and skeletal muscles.
(ii)requiring significant surgical intervention such as infected ulcers, burns upto 30%, and deep abscess.
(iii)SSTIs with a significant underlying disease state (such as diabetes) that complicates the response to treatment.
(iv)superficial infection or abscess in rectal area.
4.Suspected or proven Gm +ve bacterial infection as per following criteria:
i.Subject receiving antimicrobial therapy in last 72 hrs or on long acting antimicrobial therapy and not responding to antimicrobial therapy for cSSTIs will be considered microbiologically eligible can be enrolled, but to be continued only if the results of tissue culture show growth of gram positive bacteria by central laboratory.
ii.Naïve cases with no antimicrobial therapy in last 72 hrs and not on long acting antimicrobial therapy will be enrolled in the study if direct smear or tissue culture growth confirms the presence of the Gm +ve bacteria by gram staining or bacterial identification.
4.Subjects with at least one of the following symptoms or sign:
(i)Fever, i.e., oral temperature > 38 degree centigrade or 100.4 degree fahrenheit hypothermia i.e., oral temperature <36 degree centigrade or 96.8 degree fahrenheit
(iii)Respiratory rate more than 20/minute
(iv)Heart rate > 90/minute hypotension (SBP < 90 mm of Hg)
(vi)a white blood cell count of >12,000/mm3 or < 4000/ mm3
(vii) >10% immature neutrophils regardless of white blood cell count
5.Justified need of antimicrobial therapy for cSSTIs with Gm +ve bacteria as judged byinvestigator.
6.Subjects, who in the opinion of the PI, are most likely to tolerate oral therapy
7.Subject willing to participate in the study and subject or legally acceptable representative willing to give written informed consent.
1.Subjects not requiring antimicrobial therapy
2.Medical conditions leading to difficulty in interpreting response such as superinfected eczema and atopic dermatitis.
3.Diagnosed subjects of immunosuppressive conditions like AIDS.
4.Subjects receiving or requiring immunosuppressive therapy.
5.Subjects with osteomyelitis, septic arthritis, necrotizing fasciitis, gas gangrene and infected prosthetic device or foreign body at the infected site.
6.Subjects with endocarditis or meningitis
7.Diagnosed subjects of active complicated cardiovascular disease like IHD, CCF,arrhythmias and severe hypertension (Systolic Blood Pressure more than or equal to 160 mmHg OR Diastolic Blood Pressure more than or equal to 100 mmHg)
8.Subjects with any of the following abnormality in clinical laboratory parameters
a.SGOT (AST) and SGPT (ALT): more than 3 times the upper limit of normal laboratory range, Serum bilirubin and Serum alkaline phosphatase 15% of upper limit of normal laboratory range.
b.Blood urea and Serum creatinine 15% of upper limit of normal laboratory range.
c.Subjects with uncontrolled diabetes as determined by post prandial plasma or random(casual) plasma glucose 200 mg/dl (11.1 mmol/l)
d.Subjects with platelet count 100, 000/ cu.mm.
9.Subjects with history of Seizures,
10.History of hypersensitivity to fluoroquinolones or quinolones
11.Treatment within last 30 days with an investigational new drug.
12.Previous treatment with WCK 2349 or WCK 771.
13.Pregnant women or nursing mothers and women not practicing effective contraception, including but not limited to implants, injectables, combined oral contraceptives, intrauterine device, sexual abstinence or a vasectomized partner during the trial.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical outcome is the primary efficacy variable at test of cure visit.Timepoint: Test of Cure (Day 25)
- Secondary Outcome Measures
Name Time Method Microbiological Outcome. <br/ ><br>Timepoint: End of treatment (Day 14) and test of cure (Day 25) visit