A clinical trial which is for various bacterial infections

Phase 3

Completed

Conditions: bacterial infections like Urinary Tract Infections , skin and Skin structure infections, Lower respiratory tract infection,Surgical infections

Registration Number: CTRI/2010/091/001046

Lead Sponsor: Venus Remedies Limited

Brief Summary: This an open labeled, randomized, comparative study to evaluate efficacy and safety of test drug (Etimicin Sulphate) vs Amikacin sulphate. A total of 200 patients which lies in the age group of 18 to 60 years and are suffering from various bacterial infections will be enrolled at this multi centric two arm comparative phase-3 trial. In arm A 100 patients will be treated with Etimicin 4.5mg/kg/day while another 100 patients (Arm B) will receive treatment of Amikacin 15 mg/kg/day divided into 2 or 3 equal doses administered at equally-divided intervals. The primary objective is to establish the efficacy of test drugs , while secondary objectives of the study is to confirm the safety of both the drugs.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 200

Inclusion Criteria

Male and female subjects in the age group of above 18 years till 60 years shall be selected.
Presence of an abnormal chest x-ray (CXR) as determined by the primary care team in case of LRTI patients Clinically diagnosed subjects with Respiratory tract infections mainly LRTI (Lower respiratory tract infections) , skin & skin structure infections, UTI (Urinary tract infections), surgical infections Patients or legal guardian or LAR (Legally acceptable representative) ready to give written informed consent.

Exclusion Criteria

History of hypersensitivity reaction or any specific contraindication to Aminoglycosides or Etimicin or AmikacinPresence of hepatic or renal disordersHistory of hearing lossPregnant or lactating women.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the Efficacy of Etimicin Sulphate vs Amikacin in patients suffering from various bacterial infections	nil

Secondary Outcome Measures

Name	Time	Method
To evaluate the Safety and tolerability of Etimicin Sulphate vs Amikacin in patients suffering from various bacterial infections

Trial Locations

Locations (6): Department of Pulmonary Medicine
🇮🇳
Meerut, UTTAR PRADESH, India
Department of Surgery
🇮🇳
Gwalior, MADHYA PRADESH, India
Dr. Deepak Bhambe
🇮🇳
Delhi, DELHI, India
Dr. P.K. Jain, Professor & H.O.D
🇮🇳
Jhansi, UTTAR PRADESH, India
Dr. SidhRaj Singh
🇮🇳
Mandhi, India
Dr. Tanu Raj Sirohi
🇮🇳
Meerut, UTTAR PRADESH, India
Department of Pulmonary Medicine
🇮🇳Meerut, UTTAR PRADESH, India
Dr. Mahip Saluja
Principal investigator
09837360657
drmahip@hotmail.com