| CTRI Number |
CTRI/2011/10/002055 [Registered on: 11/10/2011] Trial Registered Retrospectively |
| Last Modified On: |
07/09/2011 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Garenoxacin Tablets in patients with Community acquired pneumonia |
|
Scientific Title of Study
|
COMPARATIVE, RANDOMISED, OPEN LABEL, PARALLEL, MULTICENTRIC STUDY, EFFICACY AND SAFETY OF ORAL GARENOXACIN VS LEVOFLOXACIN IN PATIENTS WITH COMMUNITY ACQUIRED PNEUMONIA |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CPT-NIMS-HETERO / 08 / 13 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shobha Jagadish Chandra |
| Designation |
Additional Professor |
| Affiliation |
Nizams Institute of Medical Sciences |
| Address |
Dept of Clinical Pharmacology & Therapeutics Nizams Institute of Medical Sciences
Panjagutta
Hyderabad
Hyderabad
ANDHRA PRADESH
500082
India |
| Phone |
04023355600 |
| Fax |
04023355600 |
| Email |
jcshobha@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shobha Jagadish Chandra |
| Designation |
|
| Affiliation |
NIMS |
| Address |
Dept of CP&T Nizams Institute of Medical Sciences
Panjagutta
Hyderabad
Hyderabad
ANDHRA PRADESH
500082
India |
| Phone |
04023355600 |
| Fax |
04023355600 |
| Email |
jcshobha@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
B Mohan Reddy |
| Designation |
Project Manager |
| Affiliation |
Hetero Labs Limited |
| Address |
Hetero Drugs Ltd Plot No. 80 81
APIE Balanagar
Hyderabad
Hyderabad
ANDHRA PRADESH
500037
India |
| Phone |
04023778611 |
| Fax |
04023778011 |
| Email |
b_mohanreddy@heterodrugs.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Hetero Labs Ltd |
| Address |
Hetero Corporate, Sanath Nager Industrial Estate
hyderabd |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 18 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Govind Saini |
Amar Medical & Research Center |
MD (General Medicine),
Dept. of General medicine
Kiran Path mansarovar
Jaipur
RAJASTHAN |
0141-2391892
govind.amrc@gmail.com |
| Dr Jayesh B Pavra |
Bopal Multispeciality Hospital |
M.D(Medicine), Consultant Physician,
Dept. of General medicine
Opp. Inductotherm, Bopal
Ahmadabad
GUJARAT |
02717-233043
drpavra@gmail.com |
| Dr ARTI Dhawal Shah |
Dhawal nursing home |
MBBS, DTCD, Consultant Pulmunologist
DNB,39-40, Sahajanand society
Vadodara
GUJARAT |
0265-2480235
artichest@gmail.com |
| Dr Vipin Kumar Jain |
Dr. Vipin kumar Jain Clinic |
MD (Internal Medicine) MRCPI (2) Dublin Sr. Consultant Physician, Janak 1/634 Vidhyadhar Nagar
Jaipur
RAJASTHAN |
9414055208
jainvipin17@hotmail.com |
| Dr Ajaykumar B Jain |
Gujarat Pulmonary & Critical care clinic |
MD (Tuberculosis & Respiratory Diseases, 301, swapnil-5, Nr. Commerce six roads, Navrangpura
Ahmadabad
GUJARAT |
91-97-26400108
drajaybjain@gmail.com |
| Dr Vipul M Patel |
Infectious Disease Care Clinic, Shubham super speciality Hospital, |
MD ( Medicine), F.I.I.D, Near sardar Patel Statue, IIIrd floor, Naranpura
Ahmadabad
GUJARAT |
079-29299410
vipulkaminidr@yahoo.co.in |
| Dr BLN Prasad |
King George Hospital |
M.D(General Medicine)
Dept. of General medicine
Prof. of Medicine, Civil Surgeon, Maharanipeta
Visakhapatnam
ANDHRA PRADESH |
9848211931
drnm7878@yahoo.com |
| Dr Ashok Arbat |
KRIMS Hospital |
MBBS, MD, Consultant Pulmunologist
175 central bazar RD, Ramdaspeth
Nagpur
MAHARASHTRA |
0712-2451188
ashok_arbat@yahoo.com |
| Dr Ramesh Kumar Gupta |
Marudhar hospital |
MD (Gen. Medicine),
Dept. of General medicine
A-93-99, Singh Bhoomi, Khatipura
Jaipur
RAJASTHAN |
0141-2356944
info@marudharhospital.com |
| Dr Tejas Kakkad |
Metro Hospital & Research Institute |
MD (TB & Pulmonary Medicine), Consultant Pulmunologist
Sama Savla road
Vadodara
GUJARAT |
9925207953
kakkadtejas@rediffmail.com |
| Dr GSGrewal |
S.A.S GREWAL MULTI SPECIALITY HOSPITAL |
M.D(Medicine)P.G.I., Member Newyork Academy of Science Consultant Physician and Gastroenttrologist, 96, gurdev nagar
Ludhiana
PUNJAB |
161-2404831
grewalg34@yahoo.com |
| Dr Narendra Khippal |
S.M.S. Medical College & Hospital |
M.D(Chest & Respiratory Disease),Consultant pulmunologist respiratory physician, Assistant Professor, Department of
Chest & Respiratory Disease
B-2, infront of krishna-kripa-2, Subhash nagar shopping center
Jaipur
RAJASTHAN |
141-2711299
drnkhippal@rediffmail.com |
| Dr Vasudha Sardesai |
Sardesai Clinic |
11, mulay chamber, 419 Narayan peth, shagun chowk, Laxmi Road, pune - 411030
Pune
MAHARASHTRA |
02024450220
drvasudhasardesai@gmail.com |
| Dr Praveen Garg |
Shashwat Hospital & Research |
MD (Medicine), Consultant Physician, 323, Satyam Mall, Opp. Vishwehwar Mahadev Temple,
Mansi cross road, Vastrapur
Ahmadabad
GUJARAT |
079-26610039
praveen_k_garg@yahoo.com |
| Dr Akash L Balki |
Shree Hospital & Critical Care Center |
MBBS, DNB-pulmonalogist, 799, om nagar, opp. Tajshree building, Sakkardara sq
Nagpur
MAHARASHTRA |
0712-2705904
akash_balki@yahoo.com |
| DrPratik S Desai |
Shreeji Hosital |
MD Medicine, Dept. of General medicine
B/h. Sangam Bus Stand
Sangam Char Rasta, Harni Road
Vadodara
GUJARAT |
6549559
pratikk73@indiatimes.com |
| DrManjusha Sunit Yadav |
Shreenath Hospital |
General Medicine, Uttans Building,Anandvan Complex, New IPCC Road,Subhanpur
Vadodara
GUJARAT |
0265-2395055
yadav.manjusha@gmail.com |
| Dr D Sudeena |
Teresa Health Clinic |
Cement Road, Vidyadharapuram
Krishna
ANDHRA PRADESH |
08662417729
08662417729
drsudeenaravi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| King George Hospital, Vishakapatnam |
Approved |
| VCEC, Visakhapatnam |
Approved |
| Visakha Central Ethics Committee, Visakhapatnam |
Submittted/Under Review |
| Visakha Central Ethics Committee, Vishakapatnam |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Communite Aquired Pneumonia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Garenoxacin |
Garenoxacin 2x200mg tab once daily, duration 7-10 days |
| Comparator Agent |
Levofloxacin |
Levofloxacin 500mg tab once daily, duration 7-10days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient’s atleast 18 years of age with Community Acquired Pneumonia. (Acute bronchitis, acute exacerbation of chronic bronchitis, Community Acquired pneumonia).
2. Clinical signs and symptoms consistent with Community Acquired Pneumonia suspected of being caused by bacteria susceptible to Garenoxacin and where investigator deemed oral Garenoxacin to be appropriate therapy by clinical suspicion with or without positive culture results.
3. Clinical diagnosis - Patient should have atleast two of the following signs and symptoms:
a. Cough
b. Production of purulent sputum or change in character of sputum
c. Auscultator findings of rales and / or evidence of consolidation (dullness of percussion, bronchial breath sounds or egophony)
d. Fever defined as oral temperature 380C
e. Dyspnoea or tacypnoea
f. Total WBC count 10,000 /cumm
4. Radiological diagnosis - Chest radiograph showing the presence of a new alveolar or patchy infiltrates suggestive of acute pneumonia
5. Microbiological diagnosis - Gram stain examination of sputum specimen showing presence of micro-organisms, squamous epithelial cells and polymorph nuclear cells
6. Biochemistry, haematology, and urine analysis test results without clinically significant abnormalities.
7. Patients willing to give informed written consent. |
|
| ExclusionCriteria |
| Details |
1. Pregnant and lactating women.
2. Patients with clinically significant renal or hepatic disease.
3. Patients who have shown immediate hypersensitivity reactions to the quinolone class of antibiotics.
4. Patients with bronchialasthma,bronchiectasis, cystic fibrosis, and lung abscess, AIDS, Pneumocystis caranii pneumonia, pulmonary tuberculosis, primary or secondary lung malignancy.
5. Patients with extensive bilateral consolidation and pleural effusion.
6. Patients with severe neurological or cardiovascular disease and uncontrolled diabetes mellitus
7. History of having received any investigation drugs in previous one month or has donated blood in last 3 months.
8. Patients with abnormal lab values (2 times of upper limit of normal).
9. Non co-operative attitude of the patient.
10. Any condition that, in the opinion of the investigator, does not justify the patient’s inclusion for the study.
11. Patients with any condition or concomitant infection, which in the opinion of the investigator could preclude evaluation of response to study medication |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary efficacy outcome will be clinically relevant reduction in signs and symptoms of Community Aquired Pneumonia from baseline to end treatment |
0, 4, 7/10 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The Secondary outcome is to evaluate safety by assessing the laboratory parameters, treatment emergent adverse events, and overall response of the patient & investigator at the end of the study |
0, 4, 7/10 days |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
21/07/2011 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a Comparative, Randomised, Open-label, Parallel, Multicentric study of efficacy and safety of oral Garenoxacin versus Levofloxacin in patients with Community Aquired Pneumonia. 2. The proposed number of subject to be enrolled in to the study is 250 (this number includes the expected no. of dropouts) and data will be submitted 200 completed patients. Study population will comprise of Patients with Community Aquired Pneumonia. 3. The recommended dose of Garenoxacin in dose of 2x200mg in comparison with Levofloxacin in dose of 500mg once daily for 7/10 days. 4. The primary efficacy outcome will be clinically relevant reduction in signs and symptoms of Community Aquired Pneumonia from baseline to end treatment and the secondary efficacy outcome is to evaluate of the safety by assessing the laboratory parameters, treatment emergent adverse events, and overall response of the patient & investigator at the end of the study. |