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CTRI Number  CTRI/2017/11/010388 [Registered on: 06/11/2017] Trial Registered Retrospectively
Last Modified On: 19/05/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Clinical Study to Evaluate the Efficacy and Safety of PLENMOXI (Moxifloxacin Intravenous Infusion 0.4% w/v) in the Treatment of Bacterial Infections.” 
Scientific Title of Study   A Prospective, Double Blind, Randomized, Active Controlled Clinical Study to Evaluate the Efficacy and Safety of PLENMOXI (Moxifloxacin Intravenous Infusion 0.4% w/v) of Unosource Pharma, India and AVELOX (Moxifloxacin 400mg /250 ml solution for infusion) in the Treatment of Bacterial Infections. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
ICBio/CR/UPL/0407/52 , Version 01 dated 07 Apr 2016  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr G Sreenivasa Kumari 
Designation  Physician 
Affiliation  Sri Venkateshwara Hospital 
Address  #86, Hosur main road, Madiwala

Bangalore
KARNATAKA
560068
India 
Phone  9448954282  
Fax    
Email  srinivasakumari28@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Harisha S 
Designation  Director Operations 
Affiliation  ICBio Clinical Research Pvt. Ltd. 
Address  #16 & 18 ICBio Tower,Yelahanka Main Road,Chikkabettahalli, Vidyaranyapura,

Bangalore
KARNATAKA
560097
India 
Phone  9900111997  
Fax  08023641033  
Email  harish@icbiocro.com  
 
Details of Contact Person
Public Query  
Name  Dr Harisha S 
Designation  Director Operations 
Affiliation  ICBio Clinical Research Pvt. Ltd. 
Address  #16 & 18 ICBio Tower,Yelahanka Main Road,Chikkabettahalli, Vidyaranyapura,

Bangalore
KARNATAKA
560097
India 
Phone  9900111997  
Fax  08023641033  
Email  harish@icbiocro.com  
 
Source of Monetary or Material Support  
UNOSOURCE PHARMA LTD. 503/504, 5th floor, Hubtown solaris, N.S Phadke marg, Andheri(E),Mumbai-400069, India  
 
Primary Sponsor  
Name  UNOSOURCE PHARMA LTD 
Address  503/504, 5th floor, Hub town Solaris, N.S. Phadke Marg, Andheri (East), Mumbai- 400069, India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr G Sreenivasa Kumari  Sri Venkateshwara Hospital  #86, Hosur main road, Madiwala
Bangalore
KARNATAKA 		 9448954282

srinivasakumari28@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRI VENKATESHWARA HOSPITAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Notified 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  , Bacterial Infections,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Avelox (Solution for infusion)   (Moxifloxacin 400 mg/250ml solution for infusion) Solution for infusion once daily for 14 days  
Intervention  Plenmoxi (intravenous infusion)  Moxifloxacin Intravenous Infusion 0.4% w/v, 400mg/100ml, infused once daily for 14 days  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Male or female 18 years of age or older
Evidence of acute onset of CABP with 2 or more of the following symptoms (new or worsening)
Cough
Production of purulent sputum or change in the character of sputum consistent with bacterial infection
Difficulty in breathing
Chest pain due to pneumonia and have at least 3 of the following findings:
1.Fever (oral temperature greater than 38.0°C)
2.Hypothermia (oral temperature less than 35.0°C)
3.Tachycardia (heart rate more than 100 beats/min)
4.Tachypnea (respiratory rate more than 18 breaths/min)
Hypoxemia (oxygen saturation less than 90% or PaO2 less than 60 mmHg on room air or with subject baseline [pre-CABP under study] supplemental oxygen
Clinical evidence of pulmonary consolidation and/or presence of pulmonary rates
An elevated white blood cell count (WBC) greater than 10,000/ mm³ or 15% immature neutrophils (bands), regardless of total peripheral WBC count or leukopenia with WBC less than 4500/mm³
 
 
ExclusionCriteria 
Details  A medical history of significant hypersensitivity or allergic reaction to antibiotics of the quinolone or oxazolidinone class
Any infection expected to require other systemic antibiotics in addition to study drug
Receipt of systemic antibiotic therapy in the 7 days before enrollment
One dose of a single potentially effective, short-acting antibacterial drug or drug regimen for CABP within 24 hours before enrollment is allowed
Respiratory infection confirmed or suspected to be secondary to hospital-required or ventilator-associated pneumonia or requires treatment in an intensive care setting, or mechanical ventilation
Current or suspected diagnosis of viral, fungal, or aspiration pneumonia, noninfectious causes of pulmonary infiltrates, lung cancer, cystic fibrosis, tuberculosis, empyema (not including sterile parapneumonic effusions)
Known anatomical or pathological obstruction or history of bronchiectasis or GOLD Stage 4 COPD or history of post obstructive pneumonia
Severely compromised immune system
Other exclusions include those described in the safety label for drugs in the quinolone and /or oxazolidinone classes such as QT prolongation, proarrhythmic conditions, concomitant use of drugs known to cause QT prolongation, peripheral neuropathy, tendon disorders, history of myasthenia gravis, liver disease, severe renal disease, seizures and concomitant use of MAO A or B inhibitor agents and adrenergic serotonergic agents
Subjects who are having positive serology
Pregnant and lactating women  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Assessment of changes in Clinical Evaluation in respiratory tract infections   Screening to End of Treatment  
 
Secondary Outcome  
Outcome  TimePoints 
Assessment of Changes in the microbial response in respiratory tract infections
Incidence and rate of adverse events  		 Screening to End of Treatment  
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   28/06/2016 
Date of Study Completion (India) 04/08/2016 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="0"
Days="24" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  		 A Prospective Double blind, Randomized, Active controlled Clinical Study to evaluate the Efficacy and safety of Plenmoxi ( Moxifloxacin  Intravenous Infusion 0.4 %  w/v )   and Avelox ( Moxifloxacin 400 mg / 250 ml solution for infusion ) in the  Treatment of Bacterial Infections.

Purpose of the Study :- To Compare the Safety and Efficacy of drug Plenmoxi ( Moxifloxacin Intravenous Infusion 0.4 % w/v ) and Avelox (Moxifloxacin 400 mg / 250 ml solution for infusion ) in the treatment of Bacterial Infections.

A Total of 50 subjects are enrolled in the study and followed up for 24 days.

the data will be analyzed for Non inferiority with 5 5 significance level and 80 % power for study using SAS . The difference within the groups will be assessed using paired T-test . The Difference  between the groups will be assessed using Independent T- Test
 
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