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1 Clinical Trial Details (PDF Generation Date :- Mon, 11 Mar :06:55 GMT) CTRI Number CTRI/2009/091/ [Registered on: 15/09/2009] - Last Modified On Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study Randomized, Parallel Group, Active Controlled Trial A clinical trial to study the effects of drug in pediatric subjects with complicated Skin & skin structure infection caused by Gram-positive Pathogens Study DAP-PEDS-07-03: An Evaluation of the Safety, Efficacy and Pharmacokinetics of Daptomycin in Pediatric Subjects Aged Seven to Seventeen Years with Complicated Skin and Skin Structure Infections Caused by Gram-Positive Pathogens Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) Details Contact Person (Public Query) NCT DAP-PEDS Designation Affiliation ClinicalTrials.gov Protocol Number Details of Principal Investigator Ms. Thanuja Naidu Phone Fax Designation Affiliation Pharm-Olam International () Pvt Ltd No. 217, 19th Main, 4th Cross, 6th Block Koramangala thanuja.naidu@pharm-olam.com Details Contact Person (Scientific Query) Ms.Tanuja Balachandra Phone Fax Designation Affiliation Pharm-Olam International () Pvt Ltd Pharm-Olam International () Pvt Ltd No. 217, 19th Main, 4th Cross, 6th Block Koramangala tanuja.balachandra@pharm-olam.com Details Contact Person (Public Query) Ms. Thanuja Naidu Pharm-Olam International () Pvt Ltd No. 217, 19th Main, 4th Cross, 6th Block Koramangala page 1 / 6

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Phone Fax > NIL Type of Sponsor NIL List of Countries of Principal Investigator Dr. Rachita Dhurat Source of Monetary or Material Support Primary Sponsor Details Cubist Pharmaceuticals of Site Site Phone/Fax/ BYL Nair Charitable & T N Medical College Mumbai Central, Mumbai Dr. S Sacchidananda CITI # 25/91, 20th Main Road,II Block Rajaji Nagar Dr. Ajai Gopal Jeevan Jyoti & 162 Bai Ka Bagh,Lowther Road Allahabad UTTAR PRADESH Dr. K Satyanarayana Kamineni, L.B Nagar, Hyderabad ANDHRA PRADESH Dr. Madhumati S Otiv Dr. Paras Kothari Dr. T K Sumathi Dr. Rajeev Agarwal Dr. Mukesh Kumar Gupta KEM and Lokmanya Tilak Municipal Medical College & General M S Ramaiah Memorial M V and Mahatma Gandhi Medical College & Rasta Peth,Nil Pune Sion, Mumbai MSRIT Post,New BEL Road #314/30,MIRZA mandi chowk Lucknow UTTAR PRADESH RIICO Institutional Area,Sitaapura rachitadhurat@yahoo.c o.in sacchi1260@gmail.com kamineni@kamineni.or g madhu_otiv@hotmail.c om drparaskothari@rediffm ail.com tksumathy@gmail.com drrajeeva1@rediffmail.c om page 2 / 6

3 Details of Ethics Committee Regulatory Clearance Dr. D N Balraj Medisys Clinisearch Private Limited Jaipur RAJASTHAN Dr. B S Raita Ruby Hall Clinic Department of Urology,#40 Sassoon Road Pune Diabetes Centre,#426, 4th Cross, nd Block, Kalyan drbalraj@rediffmail.com Nagar drratta@gmail.com of Committee Approval Status Date of Approval Is Independent Ethics Committee? Ethics Committe, KEM & Research Centre, Pune Ethics Committee of BYL Nair Charitable & T N Medical College Ethics Committee Poona Medical Research Foundation, Ruby Hall Clinic Ethics committee, Lokamanya Tilak Municipal Medical College & General Ethics Committee, M S Ramaiah Memorial IEC & IRB, Jeevan Jyoti & Recearch Centre IEC Consultants, CITi Institutional Ethics Committee for Clinical Research of Lucknow for MV & Institutional Ethics Committee, Kamineni Medisys Clinisearch Ethical Review Board, MediSys Clinisearch Private Limited Office of theinstitution Ethics Committee, Mahatma Gandhi Medical College & page 3 / 6

4 Status from DCGI Status Date Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Exclusion Criteria Approved/Obtained Health Type No Date Specified Condition Complicated Skin and Skin Structure Infection caused by Gram-positive pathogens Type Details Intervention Daptomycin: Experimental Drug: Daptomycin i.v. daptomycin given at 5 mg/kg (ages years) or at 7 mg/kg (ages 7-11 years) Comparator Agent Age From Age To Gender Details Details Comparator: Active Comparator Drug: Vancomycin, Clindamycin or semi-synthetic Penicillins administered per Standard of Care Inclusion Criteria Written parental (or appropriate legal representative) informed consent prior to any study-related procedure not part of normal medical care; Written subject assent (as appropriate); Male or female between the ages of 7 and 17 years old, inclusive; If female of childbearing potential (defined as post-menarche), not lactating or pregnant, documented negative pregnancy test result within 48 hours prior to study medication administration and willing to practice reliable birth control measures (at the discretion of the Principal Investigator) during study treatment and for at least 28 days after study completion; Able to comply with the protocol for the duration of the study; Skin and skin structure infections of a complicated nature known or suspected to be caused by Gram-positive pathogen(s) that require intravenous antibiotic treatment. Complicated infections are defined as infections either involving deep soft tissue or requiring significant surgical intervention (e.g. infected ulcers, burns, and major abscesses) or infections in which the subject has a significant underlying disease state that complicates the response to treatment. The Investigator may contact the Medical Monitor to discuss infections not meeting this definition but which otherwise appear appropriate for inclusion; At least three of the following clinical signs and symptoms associated with the csssi: pain;tenderness to palpation;temperature >37.5 degrees C (99.5 degrees F) oral or >38 degrees C (100.4 degrees F) rectal; white blood count (WBC) >12,000/mm3 or 10% bands; swelling and/or induration;erythema (>1 cm beyond edge of wound or abscess); pus formation Exclusion Criteria Investigational drug use (including daptomycin) or participation in any experimental procedure in the 30 days preceding study entry; Known allergy/ hypersensitivity to daptomycin; Known infection caused solely by Gram-negative pathogen(s), fungus(i) or virus(es); Previous systemic antimicrobial therapy exceeding 24 hours duration administered anytime during the 48 hours prior to the first dose of study drug (exception: a subject is eligible if on previous antibiotics without any clinical improvement and/or a wound culture is available and the pathogen is not sensitive to prior therapy); Known or suspected pneumonia, osteomyelitis, meningitis or endocarditis; Known bacteremia (exception: any subject enrolled in the study that page 4 / 6

5 Method of Generating Random Sequence Method of Concealment Blinding/Masking Stratified randomization Other Participant and Outcome Assessor Blinded is subsequently found to have a blood culture positive for bacteremia may be continued as described in section ); Subjects with current or known clinically significant abnormal laboratory test results (including ECGs) that would expose the subject to unacceptable risk as determined by Investigator; History of clinically significant cardiovascular, renal, hepatic, pulmonary (well-controlled asthma is acceptable), gastrointestinal, endocrine, hematological, autoimmune disease or primary immune deficiency [unless the Investigator considers that the subject would not be at risk by participating in the study (Note: HIV infected subjects must not be enrolled)]; History of or current clinically significant (at the discretion of the Investigator) muscular disease, nervous system or seizure disorder; Unexplained muscular weakness, history of peripheral neuropathy, Guillain-Barre or spinal cord injury; Administration of intramuscular injection between baseline and study drug administration or expected intramuscular injection through TOC/Safety visit; Suspected or known renal insufficiency; History of or current rhabdomyolysis; History of (within one year prior to first dose of study drug) or current myositis; Current septic shock; Known or suspected CPK elevation Primary Outcome Outcome Timepoints Safety of daptomycin Time Frame: First dose through end of study Secondary Outcome Outcome Timepoints Target Sample Size Phase of Trial Phase 4 Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary Efficacy of daptomycin Pharmacokinetics of daptomycin [ Total Sample Size=150 Sample Size from = No Date Specified 07/07/2008 Years= Months=0 Days=0 Completed Time Frame: End of Therapy and Test-of-Cure Visits Pharmacokinetics of daptomycin [ This is a multi-center, evaluator-blinded, randomized, comparative study designed to assess the safety, efficacy and pharmacokinetics of daptomycin in pediatric subjects ages 7-17 years, inclusive, with csssi caused by Gram-positive pathogens. Subjects will be enrolled into two age groups and given age dependant doses over a period of up to 14 days. Subjects will be stratified by age group to receive either daptomycin or standard of care (recommended as vancomycin, clindamycin or semi-synthetic penicillin) in a ratio of 2:1, respectively. Subjects may continue on oral therapy following completion of i.v. study drug administration and provided that the subject meets all criteria for conversion to oral therapy including clear clinical improvement and availability of an oral agent to which the pathogen is susceptible. The choice of oral therapy will be left to the discretion of the Investigator. This is a global trial conducted in USA, South Africa &. Estimated Study Completion date: April 2010 Estimated Primary completion date: January 2010 (Final data collection date for primary outcome measure) 100 patients are proposed to be enrolled from. Anticipated page 5 / 6

6 Powered by TCPDF ( date of enrollment for the n arm will start from 16th September page 6 / 6